Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023 

Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023 

Introduction

Recent amendments to Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), have introduced significant changes to the timelines and conditions for placing certain medical devices on the market or putting them into service. This comprehensive analysis explores the key points of these amendments, focusing on the intricate timeline considerations. 

Paragraph 3 Amendments

Paragraph 3 has undergone crucial revisions, introducing new provisions (3a to 3g) that outline conditions and timelines for the placement of medical devices on the market or into service.

Let’s delve into the details of these Regulation (EU) 2017/746 amendments: 

3a. Derogation and Conditions

By derogation from Article 5, devices falling under paragraphs 3b and 3c may be placed on the market or put into service, subject to the fulfilment of conditions specified in paragraph 3d. 

3b. Placing Devices with Certificates

Devices with certificates issued under Directive 90/385/EEC or Directive 93/42/EEC, valid by virtue of paragraph 2, can be placed on the market until specific dates: 

– Until 31 December 2027 for class III devices and class IIb implantable devices (excluding specific items). 

– Until 31 December 2028 for class IIb devices (excluding those covered by the previous point), class IIa devices, and class I devices in sterile condition or with a measuring function. 

3c. Conformity Assessment Procedure

Devices with conformity assessment procedures under Directive 93/42/EEC, not involving a notified body, may be placed on the market or put into service until 31 December 2028, provided certain conditions are met. 

3d. Conditions for Placement

Devices can be placed on the market until the specified dates (3b and 3c) if the following conditions are met by 26 May 2024: 

– Continued compliance with relevant directives. 

– No significant changes in design and intended purpose. 

– No unacceptable risk to health or safety. 

– Implementation of a quality management system by the manufacturer. 

– Lodgement of a formal application for conformity assessment by 26 May 2024 and a written agreement signed with a notified body by 26 September 2024. 

3e. Application of MDR Requirements

In derogation from paragraph 3a, devices in paragraphs 3b and 3c are subject to MDR requirements for post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices. 

3f. Responsibilities of Notified Bodies

The notified body issuing the certificate in paragraph 3b remains responsible for surveillance unless agreed otherwise. A transition of surveillance responsibilities is outlined in agreements between manufacturers and notified bodies. 

3g. Derogation for Class III Custom-made Implantable Devices

Class III custom-made implantable devices can be placed on the market until 26 May 2026 without a certificate, provided a formal application is lodged by 26 May 2024, and a written agreement with a notified body is signed by 26 September 2024. 

Paragraph 4 Replacement

Paragraph 4 stipulates that device lawfully placed on the market before 26 May 2021, and those placed afterward under paragraphs 3a, 3b, 3c, and 3g, may continue to be made available or put into service. 

Article 122 Amendments

Article 122 outlines amendments related to the repeal of Directives 90/385/EEC and 93/42/EEC, effective from 26 May 2021. Noteworthy points include the continuation of Directives’ application for devices in specific paragraphs of Article 120(3a) to (3f) and (4).

Article 123 Amendments

In Article 123(3), point (d), the amendment includes a reference to Article 120(3e), further emphasizing the continued application of certain requirements from the repealed Directives. 

Regulation (EU) 2017/746 Amendments

The amendments to Regulation (EU) 2017/746, also known as the In Vitro Diagnostic Devices Regulation (IVDR), focus on Articles 110 and 112. 

Article 110 Amendment

Devices lawfully placed on the market under Directive 98/79/EC before 26 May 2022, and those placed afterward under paragraph 3 of this Article, may continue to be made available or put into service. 

Article 112 Amendment

For devices referred to in Article 110(3) and (4) of the IVDR, Directive 98/79/EC shall continue to apply to the extent necessary for the application of those paragraphs. 

Conclusion

The recent amendments to MDR and IVDR introduce a complex framework of conditions and timelines for the placement of medical devices on the market. Stakeholders, including manufacturers and notified bodies, must carefully navigate these provisions to ensure compliance and a smooth transition to the new regulatory landscape. 

Reference Link: https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf

Navigating Medical Device Regulations: A Comprehensive Guide to Market Access in Europe, Switzerland, and the UK

Navigating Medical Device Regulations: A Comprehensive Guide to Market Access in Europe, Switzerland, and the UK

Introduction and Guide to Market Access

In the intricate landscape of medical device regulations, successfully bringing products to market requires a thorough understanding of the varying requirements in different regions.

This market access guide provides comprehensive insights into the European Union (EU), Switzerland, and the United Kingdom (UK) regulations, shedding light on crucial aspects such as Authorized Representatives, Importers, and other economic operators. 

Crafting your Marketing Strategy

A well-defined marketing strategy is the foundation for entering any market. It is essential to carefully consider the products you wish to sell and the targeted regions. While the instinct might be to reach every corner, strategic planning helps avoid unnecessary costs. 

 Post-Brexit, the complexity has increased, necessitating separate Authorized Representatives and Importers for each region. 

Understanding Economic Operators

Authorized Representatives

In the EU, a manufacturer outside the region must appoint an Authorized Representative.

The Authorized Representative, prominently identified on product labels, shoulders responsibilities such as verifying EU conformity, registration obligations, and cooperation with competent authorities. 

EU MDR Article 11: Key Responsibilities of Authorized Representatives

  • Verify the EU declaration of conformity and technical documentation. 
  • Keep copies of technical documentation and the EU declaration of conformity. 
  • Comply with registration obligations. 
  • Provide information to demonstrate device conformity. 
  • Forward requests from competent authorities to the manufacturer. 
  • Cooperate on preventive or corrective actions. 
  • Immediately inform the manufacturer about complaints and suspected incidents. 
  • Terminate the mandate if the manufacturer acts contrary to obligations. 

Importers

Importers situated within the EU play a pivotal role in ensuring products’ adherence to regulations before entering the market. They verify CE marking, proper labelling, and other compliance criteria.

Significantly, they are obliged to keep meticulous records and promptly address non-compliance concerns. 

EU MDR Article 13: Duties of Importers

  • Place on the market only devices in conformity with the regulation. 
  • Verify CE marking, EU declaration of conformity, and manufacturer’s identification. 
  • Ensure proper labeling and instructions for use. 
  • Verify UDI assignment by the manufacturer. 
  • Maintain a register of complaints, non-conforming devices, recalls, and withdrawals. 
  • Cooperate with authorities on corrective actions. 
  • Inform the manufacturer and authorities about non-compliance and serious risks. 

The European Market

EU MDR 2017/745 and IVDR 2017/746

For medical devices and in-vitro diagnostics, compliance with EU MDR and IVDR is paramount. Manufacturers must meticulously follow the regulatory requirements outlined in these legislations.

Initiating with Article 10 and ensuring conformity with EU standards is the cornerstone. 

EU MDR Article 10: General Obligations of Manufacturers

  • Verify compliance with legislation, specifically EU MDR or IVDR Article 10. 
  • Comply with the requirements of EU MDR or IVDR Article 10 for economic operators. 
  • Provide necessary information to authorized representatives and importers. 

Authorized Representative

The EU Authorized Representative must be well-versed in EU MDR and IVDR requirements. The role encompasses tasks from verifying documentation to cooperating with authorities.

Transparency is critical, with the Authorized Representative’s details prominently displayed on product labels. 

Importer

Importers act as the last line of defence before products hit the market. As per Article 13, their verification processes ensure that only compliant devices enter the EU.

The importer’s role includes handling complaints, cooperating with competent authorities, and maintaining a comprehensive register. 

EUDAMED Registration

EUDAMED, the European Database for Medical Devices, plays a pivotal role in the regulatory landscape. Manufacturers, Authorized Representatives, Importers, and other entities must register in EUDAMED to obtain the Single Registration Number (SRN).

This digital hub facilitates information exchange, ensuring transparency and traceability. 

EUDAMED Registration Process

EUDAMED, the European Database for Medical Devices, is pivotal for transparent information exchange among stakeholders. The registration process involves: 

1. Identify your Role

Determine if you’re a Manufacturer, Authorized Representative, or Importer, each with unique responsibilities.

2. Access EUDAMED

Create an account on the user-friendly EUDAMED platform

3. Provide Details

Enter essential company information and specify your role.

4. Verification

Undergo a verification process to confirm the legitimacy 

5. Get SRN

Receive a Single Registration Number (SRN) upon successful verification.

6. Maintain Compliance

Regularly update the information to stay compliant. 

7. Information Exchange

Utilize EUDAMED for efficient information exchange with authorities and stakeholders. This streamlined process ensures regulatory compliance and facilitates seamless interaction within the EU’s medical device landscape. 

Switzerland

Post-Brexit

Switzerland, no longer part of the Mutual Recognition Agreement, mandates manufacturers outside the EU to appoint Authorized Representatives and Importers within Switzerland. The regulations mirror EU MDR and IVDR, emphasizing compliance. 

Differences in Switzerland

While Switzerland aligns closely with EU regulations, distinctions exist. The CH-REP symbol stands in for the EC REP symbol, and a unique registration process, distinct from EUDAMED, adds a layer of complexity. 

UK Market Access: Navigating the Post-Brexit Scenario

The UK Responsible Person

Post-Brexit, the UK Responsible Person assumes a role akin to the EU Authorized Representative. The UK MDR 2002 sets out responsibilities, emphasizing conformity checks, complaint management, and immediate reporting of non-compliance. 

UK MDR 2002 Responsibilities of the UK Responsible Person

  • Ensure the declaration of conformity and technical documentation are in order. 
  • Keep copies of technical documentation and the declaration of conformity. 
  • Provide information to demonstrate device conformity to the MHRA. 
  • Cooperate with the MHRA on preventive or corrective actions. 
  • Immediately inform the manufacturer about complaints and suspected incidents. 
  • Terminate the legal relationship if the manufacturer acts contrary to obligations. 

Symbolic Absence

Unlike the EU, the UK lacks a designated symbol for the Responsible Person. The absence prompts a textual mention on labels. Notably, this requirement applies to UKCA-marked products post-Brexit. 

Conclusion

Navigating the regulatory landscape for medical devices demands a nuanced understanding of region-specific requirements.

From strategic marketing planning to compliance with EU, Swiss, and UK regulations, this guide provides a detailed roadmap for manufacturers aiming to ensure seamless market access while embracing the intricacies of post-Brexit realities.

EUDAMED is a pivotal component, serving as the digital nexus for regulatory information exchange, ensuring compliance and traceability. 

Mastering Medical Device Audits: A Roadmap to Preparedness and Compliance Excellence

Mastering Medical Device Audits: A Roadmap to Preparedness and Compliance Excellence

Facing a medical device audit can be daunting, but with meticulous preparation and strategic responses, companies can turn this challenge into an opportunity for building a robust quality system.

Tips for Mastering Medical Device Audits

This article provides a detailed roadmap for mastering medical device audits, covering essential steps from internal audits to adeptly handling regulatory findings.

1. Demystifying Audits

Understanding the fundamental concepts behind medical device audits is crucial. ISO 19011 defines audits as systematic, documented, and independent processes for obtaining objective evidence.

This section also outlines the different types of audits, including internal and external audits conducted by regulatory bodies.

2. Navigating US and EU Audits

Medical device audits are mandatory for all device classes, but specific requirements vary depending on regulatory bodies and device classification.

In the EU and US, audits for medium to high-risk devices typically involve Notified Body audits for MDR/IVDR compliance and ISO 13485:2016 certification, FDA inspections for 21 CFR 820 compliance and manufacturing capability verification, and periodic surveillance audits.

Additionally, manufacturers are subject to unannounced and “for cause” inspections triggered by various issues.

3. Strategic Audit Preparation

Thorough preparation for an audit or inspection involves continuous auditing practices, mock audits, and self-identification of issues. Internal audits should be conducted rigorously, acting as rehearsals for external audits.

Mock audits, conducted by independent third parties, can reveal areas for improvement. Self-identifying issues and implementing corrective actions promptly demonstrates a proactive approach to compliance.

4. Selecting the Ideal Audit Host

When selecting an audit host, it’s crucial to choose someone who represents the company well, possesses in-depth knowledge of its operations and quality management system, and can handle pressure effectively.

The audit host is pivotal in ensuring a smooth and successful audit, so selecting the right individual is essential.

5. Document Readiness for Audits

To ensure a smooth audit process and avoid delays, organizations should pre-identify and readily have all necessary documents, including regulatory information, certificates, and records.

A centralized regulatory information management (RIM) system can significantly streamline the process by storing and linking to relevant documents from other systems.

6. Audit In-Action

During an audit, it is crucial to actively manage the process. The company host should introduce the organization and conduct a facility tour. While the auditor directs the audit, the host should assist and guide them throughout the process.

For unannounced inspections, a procedure should outline the reception and handling of such audits, including designating primary contacts and alternates.

Ideally, multiple company representatives should accompany the auditor, and they should not be left alone at any point. A “front room” team should transcribe every interaction and relay information to a “back room” team for support.

7. Best Information Sharing Practices

Employees should provide requested information to auditors but should consult with executives before sharing sensitive documents. Auditors should access information through photocopies or limited computer access.

Original documents can be presented but should not be kept by auditors. All information should be prepared, verified, recorded, and marked “Confidential” or “Proprietary” before being provided to auditors. An extra copy should be made for audit files.

8. Addressing Gaps in Information

Address missing or incorrect information by acknowledging the issue and discussing appropriate actions under the existing quality system. Be prepared to receive findings from any inspection and ensure that they are understood by both parties.

Address all findings diligently and respond to the regulatory body in charge of the audit with a satisfactory plan for correcting and preventing the recurrence of the identified issues.

Conclusion

In conclusion, medical device audits, though challenging, can be navigated successfully with thorough preparation and strategic responses.

Embrace the audit journey as an opportunity for continuous improvement, showcasing a commitment to compliance and the delivery of safe and effective medical devices.

Mastering medical device audits is not just a regulatory requirement – it’s a pathway to excellence in quality systems and product lifecycle management.

Software As a Medical Device and Its Clinical Evaluation

Software As a Medical Device and Its Clinical Evaluation

As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely integrated into digital platforms serving both medical and non-medical purposes. Medical device software is one of three types of Software related to medical devices.

The other two types of medical device software include Software that is an integral part of the medical device (medical device software) and Software used in manufacturing or maintaining the medical device.

Software as a Medical Device Introduction

The International Medical Device Regulators Forum (IMDRF) defines SaMD as “software intended for one or more medical purposes that perform those purposes without being part of a hardware medical device.”

FDA defines SaMD as “Software that meets the definition of a device in 181 section 201(h) of the FD&C Act and is intended to be used for one or more medical purposes without being part of a hardware device.”

The use of SaMD is experiencing a steady rise, with its application extending to various technology platforms such as medical device platforms, commercial “off-the-shelf” platforms, and virtual networks, among others.

This kind of software was previously referred to as “standalone software,” “medical device software,” or “health software” by industry professionals, international regulators, and healthcare providers, often leading to confusion with other software categories.

How Do I Know if My Product is SaMD?

As a member of the International Medical Device Regulatory Forum (IMDRF), the FDA recognizes the structural similarity between the two organizations’ definitions of SaMD. The definitions provided by the FDA and IMDRF highlight two criteria that must be satisfied for software to be designated as SaMD.

To evaluate if the Software is a medical device, it is important to assess its compliance with the regulatory authority’s definition. The IMDRF emphasizes that the Software must be “intended for one or more medical purposes”. On the other hand, the FDA references FD&C, or the Federal Food, Drug, and Cosmetic Act, Section 201(h),  which outlines the definition of a device. This section defines a device as follows: 

According to Section 201(h) of the FD&C, a device encompasses various articles such as tools, implements, instruments, machines, devices, appliances, in vitro reagents and other similar or related items, including components and accessories.

  1. An article must also be legally recognised in the National Formulary, the United States Pharmacopoeia, or an analogous revision in order to meet the requirements of Section 201(h) of the FD&C Act’s definition of a device.     
  1. The product is intended to be used in the diagnosis of disease or other conditions as well as in the treatment, mitigation, treatment, or prevention of disease in people or animals, according to the definition of a device under FD&C Section 201(h).   
  1. In addition, a product must be intended to change any structure or function of the human or animal body without compromising its primary function for it to qualify as a device under Section 201(h) of the FD&C Act.

In addition, the definition of a device in Section 201(h) of the FD&C Act states that it must not achieve its primary purpose by chemical action in or on the human or animal body, nor must it rely on metabolism to achieve its purpose.

Note that the term “device” does not include software features that are excluded by Section 520(o). To apply this definition, it is essential to establish the intended use and indications for the use of your product. To refresh your understanding,

  • The intended use of a device refers to its designated purpose or the specific function for which the device is intended to be utilised. In other words, it defines the intended or intended application of the device
  • Indications for use pertain to the diseases or conditions that a device is designed to diagnose, treat, prevent, cure, or mitigate. These indications specify the target patient population and provide insights into why the device would be used on individuals with those diseases or conditions

Once the intended use and indications for the use of your product are defined, the second and third points in the FDA’s definition of a medical device will help determine whether your product falls under the regulatory scope of a medical device. These criteria will clarify whether your product meets the requirements for medical device regulation.

If you intend to market your software product in the United States, I recommend carefully reviewing the FDA’s guidance on Policy for Device Software Functions and Mobile Medical Applications.

This guidance provides valuable insights into the specific software functions that the FDA classifies as medical devices and functions that are not considered medical devices and, therefore, not subject to FDA regulation. Familiarizing yourself with this guidance will provide you having a thorough awareness of the regulatory environment for software products in the medical field.

If you’re still unsure about whether your product qualifies as a medical device, contacting the FDA directly for clarification is safest. Contacting the FDA now will provide reliable advice and ensure you receive accurate information tailored to your specific product and situation.

Is My Software Considered SaMD or SiMD?

When a product is found to fit the definition of a medical device, the second portion of the IMDRF and FDA definition of software as a medical device (SaMD) must be taken into account.

  1. According to the IMDRF definition, Software must be used for its intended purpose only and must not be an integral part of a physical medical device.  
  1. According to the IMDRF, the FDA makes it clear that Software as a Medical Device (SaMD) is not a part of a hardware device and is instead intended for standalone usage for one or more medical purposes.

This further limit the scope of Software as a medical device (SaMD), as the Software used to operate or control a hardware device does not fulfil the requirements to be categorised as a SaMD. Instead, this type of Software is referred to as SiMD or “software in a medical device.”

Here are some examples of Software that assist in operating a hardware medical device, which falls under the category of Software in a Medical Device (SiMD) and not Software as a Medical Device (SaMD):

  1. Software that controls the inflation or deflation of a blood pressure cuff
  2. Software that controls the delivery of insulin on an insulin pump
  3. Software used in the closed-loop control of a pacemaker.

“firmware,” or “micro-code,” indicating their classification as SiMD rather than SaMD.

To qualify as SaMD, a product must have standalone Software that independently carries out the functions defining it as a medical device, distinct from any associated hardware. The IMDRF guidance on “Possible Framework for Risk Categorization and Corresponding Considerations” further provides additional insights and clarifications regarding the SaMD definition.

1. SaMD is a medical device, including in-vitro diagnostic (IVD) medical devices.

2. SaMD can run on general-purpose computing platforms not specifically designed for medical purposes.

3. “Without being part of” means the Software is unnecessary for a hardware medical device to achieve its intended medical purpose.

4. Software intended to drive a hardware medical device does not meet the definition of SaMD.

5. SaMD can be combined, such as being integrated as a module, with other products, including medical devices.

6. SaMD can interface with other medical devices, including hardware medical devices, other SaMD software, and general-purpose Software.

7. Mobile apps that meet the defined criteria are considered SaMD.

Although it is crucial to distinguish between Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), both types of Software adhere to many common standards for development, including the global standard for software lifecycle procedures is IEC 62304.  lifecycle processes.

If your Software falls under the category of SiMD, you will still find the guidance documents and standards outlined in this guide valuable and applicable.

What are Some Examples of SaMD?

1. Software that enables a mobile device to view diagnostic images from MRI, ultrasound, or X-ray scans.

2. Software that utilizes image processing techniques to aid in detecting breast cancer.

3. Software that diagnoses a medical condition by analyzing data from the tri-axial accelerometer on a smartphone.

4. Software that collects real-time patient data monitored by a healthcare professional and utilized to develop treatment plans.

Clinical Evaluation

Clinical evaluation is a methodical and well-organized process that creates clinical evidence by continuously creating, collecting, analyzing and evaluating clinical data on SaMD to create clinical trials that review the clinical context and performance indicators of SaMD.

The quality and scope of the clinical assessment is based on the SaMD function for the clinical objective, which also ensures that the SaMD   score is clinically valid and can be used consistently and predictably. 

3 Clinical Evaluation Software

To qualify the software, the following three criteria must be met. To qualify your software, you must meet the three criteria outlined below.

  • Valid Clinical Association of a SaMD
  • Analytical/Technical Validation of a SaMD
  • Clinical Validation

1. Valid Clinical Association of a SaMD

Verifying that your software’s output corresponds to the targeted clinical conditions is the main goal here. Use of secondary data analysis, clinical trials (new data generated), professional society guidelines, original clinical research, literature searches, and/or secondary data analysis are all options for carrying out that task. All SaMD should show a reliable clinical association.

2. Analytical/Technical Validation

Does your software correctly process input data to generate accurate, dependable, and precise output data?” is the question we are attempting to answer in this context. Develop supporting documentation that demonstrates your SaMD’s output met your expectations in terms of technicality.

This action is being assessed by a manufacturer as part of the software’s validation and verification phase (V&V).

3. Clinical Validation

SaMD has been evaluated in your target population and for your intended use; users are able to achieve clinically significant results through consistent and dependable use.

Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices

Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices

According to European Union Medical Device Regulation (EU MDR) the term “Vigilance” is the identification, reporting and trending of serious incidents and the conduct of safety-related corrective actions (Market surveillance and vigilance).

An ‘incident’ as per article 2(64) MDR is any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.

A ‘serious incident’ as per Article 2(65) MDR is an incident as outlined in Article 2(64) MDR that has in addition, either led to or has the potential to lead to significant health or public health outcomes.

In essence, serious incidents refer to a particular category of incidents that have caused, have the potential to cause, or may cause death or severe harm to a patient, user, or any other person.

These incidents can also pose a significant threat to public health. As per Article 87(1) to (5) of the MDR, it is the responsibility of the manufacturer to report such serious incidents to the appropriate regulatory authority.

Any incident which meets all three basic reporting criteria A to C listed below is considered a serious incident and must be reported to the relevant competent authority:

  1. An incident has occurred

Examples:

  • A malfunction or deterioration in the characteristics or performance of the device, e.g. a device that fails or is losing its ability to achieve its intended purpose when used as indicated in the information supplied by the manufacturer
  • A deterioration in the characteristics of the device that is related to manufacturing errors, e.g. sterilization process failures
  • A use error due to ergonomic features, e.g. a use error caused by a mismatch between the user interface and the physical or medical condition of the intended user
  • Any inadequacy in the information supplied by the manufacturer, e.g. insufficient information on how to maintain, adjust or calibrate the device in the instructions for use
  • Unclear instructions in the labelling or the manufacturer’s instructions for use
  • Undesirable side-effects e.g. allergic skin reactions such as allergy to nickel or wound therapies
  • Incident directly or indirectly led, might have led or might lead to any of the outcomes of a serious incident such as death of a patient, user or other person; temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health; or a serious public health threat. Read more on the concept of vigilance in EU MDR on our website.

Examples of serious public health threats:

  • Contagious illnesses, such as HIV, Ebola, Zika virus, SARS and COVID-19
  • Events involving high risk of exposure to a disease (e.g., cancer) after use of a medical device, which affects a specific patient population (diabetics, cardiac patients, etc.) or a vulnerable population (children, pregnant women, etc.)
  • Exposure to toxic compounds with a potentially negative/harmful effect on humans
  • Widespread distribution of falsified or incorrectly labelled devices leading to multiple serious incidents, e.g. distribution of non-sterile devices labelled as sterile
  • Cyberattack related to life supporting or life-saving devices
  • Causal relationship between the serious incident and the manufacturer’s device has been established or is reasonably possible or suspected.

User, Use error and Abnormal use of a medical device

According to Article 2(37) of the MDR, a “User” refers to any healthcare institution, healthcare professional, or lay person (such as a caregiver or patient) who uses a device, as well as those who install or maintain the device. The term “operator” may also be used to refer to the user of a device.

A “use error” occurs when the actions or inactions of the user while using the device result in a different outcome than intended by the manufacturer or expected by the user.

This can be due to various reasons such as lack of attention, memory lapses, mistakes during device use, or insufficient knowledge or understanding of device use.

Such use errors are not considered incidents, but if they are caused by ergonomic features of a device, they are considered incidents and must be reported under Article 87(1) of the MDR in case of serious incidents.

“Abnormal use” refers to the intentional violation of the intended use of a device. This may involve deliberate acts or omissions that deviate from the normal use of the device and cannot be controlled by the manufacturer.

For example, when a doctor uses a device for an indication that is not specified in the manufacturer’s instructions for use.

“Use-error due to ergonomic features” refers to use errors caused by the physical features of a device that are designed to ensure safe, effective, and efficient interaction between the user and the device.

These errors may occur when there is a mismatch between the device features and the user profile or the environment in which the device is used.

Ergonomic features can be described as the physical features of a device that are designed to facilitate and ensure that the interaction between the user and the device is safe, effective and efficient.

Ergonomic features include components such as measurement and monitoring features, display scales, alarms, software menus, and other factors related to the user interface.

Reporting under MDR

The MDR mandates that the timeline for reporting serious incidents should be based on the severity of the incident. These reporting periods are counted as calendar days.

Typically, the reporting period begins the day after the manufacturer becomes aware of a potentially serious incident. The awareness date, which is considered day 0, is when the manufacturer first receives information about the incident, not after any investigation has been conducted.

The manufacturer’s awareness date is determined as the day when any employee or representative of the manufacturer’s organization first receives information, such as a complaint, about the potentially serious incident.

This can be illustrated with an example:

On June 1, 2022, a manufacturer receives a complaint but decides that it does not meet the criteria for a serious incident, so they do not submit a Manufacturer Incident Report (MIR) to the relevant authority.

However, on July 1, 2022, the manufacturer receives more information and reviews it, and now determines that the complaint is indeed a serious incident. The manufacturer must thus submit a MIR no later than July 16, 2022.

In the MIR, the manufacturer should provide the relevant dates in the following two fields:

  • ‘Manufacturer awareness date’ – in this field, the initial awareness date of the incident should be inserted by the manufacturer.
  • ‘General comments’ – in this field, the manufacturer should insert the date in which it received the information that determined that the incident is reportable

A ‘field safety corrective action (FSCA)’ is a corrective action taken by a manufacturer for technical or medical reasons to either prevent or reduce the risk of a serious incident, which is associated with a device that is made available on the market.

A Field Safety Corrective Action (FSCA) can involve various actions such as returning the device to the supplier or recalling it, exchanging the device, modifying it, retrofitting it with the manufacturer’s modification or design change, destroying it, giving advice on the device’s use, recommending inspections/examinations of the device by the user, making changes to the device’s software/firmware, and updating the device’s version (for example, rolling it back to an earlier version).

Example of an FSCA conducted by a manufacturer:

As a part of monitoring their products after they have been released to the market, the manufacturer has found a consistent issue with one of their devices.

If this issue could result in a serious problem and the affected devices are still being sold, the manufacturer is required to initiate a FSCA (Field Safety Corrective Action) to prevent or minimize the risk of such incidents.

This FSCA may involve making permanent or temporary changes to the device’s labeling or instructions for use, or recalling all of the affected devices from the market. The manufacturer must promptly inform the relevant authorities in the Member States where the FSCA is being carried out.

Vigilance Reporting in Eudamed

Eudamed is a recently established database by the European Union for medical devices, designed to gather all necessary information about devices that have been made available in the Union market.

The details of the database can be found in Article 33 MDR, while the rules regarding vigilance are described in Article 92 MDR. The Medical Device Coordination Group (MDCG) guidance provides suggestions on temporary measures that can be used to comply with certain MDR requirements related to Eudamed and information sharing.

These alternatives enable Member States and other stakeholders to fulfill their obligations under the MDR until the complete operation of the database.

Periodic Summary Report

A “Periodic summary report” (PSR) is another way for manufacturers to report serious incidents involving the same device or device type in a consolidated manner.

This reporting method is used when the manufacturer agrees with the relevant national competent authority that coordinates periodic summary reporting.

The PSR is based on certain criteria, which includes situations where the root cause of the incidents has been determined, a Field Safety Corrective Action (FSCA) has been implemented, or where the serious incidents are commonly known and documented.

A ‘common and well documented serious incident’ as referenced in Article 87(9) MDR, must be clearly identified in the manufacturer’s risk analysis and should have led to incident reports, which have been assessed by the manufacturer and the relevant competent authority.

FAQs

Who is responsible for vigilance activities related to medical devices?

The manufacturer of a medical device is responsible for vigilance activities related to that device. This includes monitoring the device’s performance, investigating any incidents or complaints related to the device, and reporting any adverse events to the relevant authorities.

What is a trend report?

A trend report is a summary of adverse event data related to a particular medical device or group of devices. It is used to identify patterns or trends in adverse events and to assess the potential risks associated with the device.

What are the basic reporting criteria for a serious incident?

·         An incident (Article 2(64) MDR) has occurred
·         The incident directly or indirectly led, might have led or might lead to any of the outcomes of a serious incident (Article 2(65) MDR)
·         A causal relationship between the serious incident and the manufacturer’s device has been established, is reasonably possible or suspected

Technical Documentation Requirements MDD Vs MDR

Technical Documentation Requirements MDD Vs MDR

Check out the difference between MDD vs MDR

MDD vs MDR

MDD

A MDD Technical documentation must include:

  • A general device description, including any information on any planned variants
  • Design drawings, details on the planned method of manufacture, diagram of components, sub-assemblies, circuits etc
  • Descriptions and explanations are required to understand the abovementioned drawings and diagrams and the operations of the product
  • Results of risk analysis and a list of standards that are applied in full or part (Standards are referred to in Article 5 MDD)
  • Description of the solutions adopted to meet the essential requirements of the Directive if standards have not been applied fully. (Standards are referred to in Article 5 MDD)
  • Sterility information, description, and methods of use of sterile products
  • Results of design calculations and inspections carried out
  • If the device is to be connected to other device(s) to operate as intended, then there must be proof provided to indicate that it conforms to the essential requirements when connected to any such device(s) having characteristics specified by the manufacturer
  • Test Reports
  • Clinical Reports wherever applicable and Clinical data as per Annex X of MDD
  • Label and Instructions for use

MDR

All Technical documentation requirements of MDD must be presented for the MDR alongside the below additional list:

Device Description and Specifications

  • Basic UDI-DI
  • the intended patient population and medical conditions to be diagnosed
  • contra-indications and warnings
  • principles of operation of the device and its mode of action
  • the rationale for the qualification of the product as a device
  • the risk class of the device and the justification for the classification rule(s) applied
  • an explanation of any novel features
  • A description of the accessories for a device, other devices and other products that are not devices intended to be used in combination with it.
  • a description or complete list of the various configurations/variants of the device
  • a general description of the key functional elements, e.g., its parts/components
  • a description of the raw materials incorporated into key functional elements and those making either direct contact with the human body or indirect contact with the body
  • Technical specifications
  • Reference to previous and similar generations of the device

Information to be supplied by the manufacturer

  • A complete set of labels or labels on the device and on its packaging
  • The instructions for use in the languages accepted in the country of sale

Design and Manufacturing Information

  • information to allow the design stages applied to the device to be understood
  • complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing
  • identification of all sites, including suppliers, sub-contractors and manufacturing sites.

General Safety and Performance Requirements

  • The general safety and performance requirements that apply to the device and an explanation as to why others do not apply
  • The method or methods used to demonstrate conformity with each applicable general safety and performance requirement
  • the harmonised standards, CS or other solutions applied
  • the precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity

Benefit-Risk Analysis and Risk Management

The benefit-risk analysis, the solutions adopted, and the results of the risk management

Product Verification and Validation

The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate the conformity of the device with the requirements of this Regulation.

Pre-Clinical and Clinical data

  • Results of tests
  • If applicable: biocompatibility report, physical, chemical and microbiological characterisation, electrical safety and electromagnetic compatibility, software verification and validation,
  • stability, including shelf life,
  • performance and safety
  • Where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and of the Council (1) shall be demonstrated
  • Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision
  • the clinical evaluation report and its updates and the clinical evaluation plan
  • the PMCF plan and PMCF evaluation report, and if not applicable, justification of why a PMCF is not applicable

Additional information required in specific cases

Data of the tests conducted to assess safety, quality and usefulness on:

  • Medicinal product used
  • Medicinal products derived from human blood or human plasma
  • Tissues or cells of human or animal origin or their derivatives
  • Substances or combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body
  • CMR (carcinogenic, mutagenic, or toxic for reproduction) substances
  • Endocrine-disrupting substances

A description of:

  • Sterility or defined microbiological condition to be maintained
  • Methods used in devices with measuring functions to ensure the accuracy as given in the specifications.
  • Combination/configuration of devices connected to other devices (s) to operate as intended, including proof that it conforms to the general safety and performance requirements when connected to any such device(s) having regard to the characteristics specified by the manufacturer

Post Market Surveillance

  • Post-market surveillance plan drawn up in accordance with Article 84

Post Market surveillance plan shall address:

  • Information concerning serious incidents, including information from PSURs, and field safety corrective actions
  • Records referring to non-serious incidents and data on any undesirable side-effects
  • Information from trend reporting
  • Relevant specialist or technical literature, databases and/or registers
  • Information, including feedback and complaints, provided by users, distributors and importers
  • Publicly available information about similar medical devices

The post-market surveillance plan shall cover at least:

  • A proactive and systematic process to collect any information
  • Effective and appropriate methods and processes to assess the collected data
  • Suitable indicators and threshold values shall be used in the continuous reassessment of the benefit-risk analysis and the risk management
  • Effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field
  • Methods and protocols to manage the events subject to the trend report
  • Methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators, and users
  • Reference to procedures to fulfil the manufacturer’s obligations
  • Systematic procedures to identify and initiate appropriate measures, including corrective actions
  • Effective tools to trace and identify devices for which corrective actions might be necessary
  • A PMCF plan, or a justification as to why a PMCF is not applicable

The PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85

Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.