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

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.

MHRA Guidance on Stand-alone Software Medical Devices

MHRA Guidance on Stand-alone Software Medical Devices

Medical device apps are increasingly growing these days. MHRA has issued new guidance on the stand-alone software medical devices, including apps. This guidance is a crucial document for manufacturers and users of such medical devices.

In the UK, medical devices are subject to UKCA marking. The UKCA marking is no exception to software medical devices.

Software Medical Devices or not

Classifying software or a mobile app as a medical device can be challenging. If the software or app has a well-defined intended medical purpose, it is essential to mark CE or UKCA on the product.

This ensures that the device conforms to the requirements of the regulation of the EU and UK and is safe for use. The flow chart provided below helps determine if the software is a medical device, in vitro diagnostic device, active implantable, or accessory.

Flowchart on the classification of software into medical device
Source: MHRA Software flowchart

Intended purpose

A medical device is defined by the intended purpose on the device labelling, Instructions for use and any promotional materials, including brochures.

Depending on the intended purpose, the device can be classified as a device with a medical purpose if it:

  • Prevents disease
  • Diagnoses a disease, injury or handicap
  • Monitoring a disease, injury or handicap
  • Treats or alleviation of a disease, injury or handicap
  • Compensates an injury or handicap
  • Investigates replaces or modifies anatomy or physiological process
  • Controls conception

A software device is considered to have a medical purpose if it has one of the following features and looks into in vitro data:

  • Concerning a physiological or pathological state          
  • Concerning a congenital abnormality
  • To determine the safety and compatibility with potential recipients
  • To monitor therapeutic measures

Software Medical device classification and essential requirements

For software medical devices, the following classification rules of Medical Device Directive 93/42/EEC  apply.

  • Rule 9 includes active therapeutic devices intended to administer or exchange energy
  • Rule 10 includes active devices intended for the diagnosis
  • Rule 12 includes all other active class I devices
  • Rule 14 includes devices used for contraception or the prevention of the transmission of sexually transmitted diseases

One of the essential requirements for software apps is for the benefit to outweigh any risks. Essential requirements also state the risks of ergonomic features and the intended use environment.

Manufacturers of such devices must ensure that the user interface must be consistent, and graphics and text must be clear and legible. The software or app must be designed with safety in mind.

In addition, the clinical evaluation following Annex X of the UK MDR must be done. A similar set of requirements applies to IVDs.

Labelling requirements

The software labelling must be clear and visible to the user. Manufacturers must ensure the app meets relevant requirements and displays UKCA  marking on the landing page itself.

The following particulars must be present on the software label:

  • App name
  • Version number
  • Date of manufacture
  • Manufacturer name and address
  • UKRP name and address
  • Purpose of software
  • Warnings and precautions
  • UKCA or CE marking
Labelling for an app with medical purpose

Examples of Software with a medical purpose

Software with a medical purpose may be devices that:

  • Provide information for the calculation of drug dose using IVD data such as blood
  • Enables therapeutic drug monitoring
  • Monitor blood glucose levels
  • Provides medical conditions based on input user data
  • Indicate potential developing disease based on the entered data
  • Automate the pathway for treatment for an individual
  • Enables people with visual or hearing disabilities to read or listen by magnifying text or amplifying sounds

Software or app without an intended medical use would include:

  • General apps for recording patient images which later require the diagnosis of a clinician
  • Apps that give general recommendations instead of user-specific advise
  • Software that is intended to record heart rates, such as fitness or sports apps
  • Apps that remind patients of drug intake
  • Apps to treat non-medical conditions
  • Software that provides tips or advice

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

Article 61 Clinical Evaluation in the EU MDR

Article 61 Clinical Evaluation in the EU MDR

Article 61 Clinical Evaluation

The MDR reinforces the clinical data and evaluation process (article 61 and Annex XIV), and the manufacturer must confirm the device’s conformity to fundamental health and safety requirements using reliable clinical data and evaluation.

The clinical evaluation establishes the device’s safety and capacity to fulfil its intended function. It also evaluates adverse side effects and determines whether the benefit-risk ratio is acceptable.

Manufacturers must plan, carry out, and document a clinical evaluation in line with Article 61 and Part A of Annex XIV.

Clinical data for the medical device are created, compiled, examined, and ultimately evaluated through a systematic and organised process called a clinical evaluation.

The Clinical Evaluation Report (CER), which the manufacturer uses to show that the medical device complies with the general safety and performance requirements specified in Annex I of the MDR, is the end result of the clinical evaluation.

The Clinical Evaluation Report (CER) is an essential component of a manufacturer’s quality management system and an essential component of the technical documentation for the medical device (MDR Article 10 (3)). It must be actively updated on a regular basis utilising information from the post-market clinical follow-up and post-market surveillance of the medical device (PMCF).

Thus, clinical evaluation is a continuous procedure throughout a medical device’s life cycle.

The Objective of Clinical Evaluation

The clinical evaluation aims to show that the medical device can be used as intended while still being safe and effective, including in terms of its clinical advantages.

The clinical evaluation can also be used to reevaluate risks and find previously overlooked hazards or dangers. The acceptability of hazards must be reevaluated by manufacturers using the most recent clinical evidence.

The objectives of the clinical examination include:

  • The product’s use for its intended purpose under normal circumstances demonstrates conformity with the general safety and performance requirements listed in Annex I of the MDR
  • Evaluating or excluding undesirable side effects
  • Proof of the validity of the risk-benefit ratio
  • Proving the makers’ medical claims.

Alternative product methods and technologies that can be used in place of the treatment being evaluated are evaluated and documented as part of the clinical study.

The clinical evaluation must ensure that the tested product is not worse than the potential substitutes. The clinical evaluation needs to describe and assess the state of the art.

When assessing state of the art, clinical benefits, safety, and performance should be taken into account. When designing and producing their products, medical device makers must take the latest technological advancements into account.

Clinical Evaluation Data

Clinical information gathered while using the medical device forms the basis of the clinical evaluation. The following are some potential sources for these:

  • Clinical trial(s) conducted by the manufacturer of the medical device
  • Clinical trial(s) or other research on a known similar product from the scientific literature
  • Data from post-market surveillance (PMS) are clinically significant, particularly from post-market clinical follow-up (PMCF).
  • Reports regarding additional clinical trials using the product under review or a comparable product that has been published in the peer-reviewed scientific literature

Manufacturers must consider preclinical data in addition to clinical data when making their clinical evaluations.

For instance, this comprises the outcomes of the following tests: Testing for biocompatibility, electrical and mechanical safety electromagnetic compatibility in accordance with IEC 60601-1-2, usability, software, animal, simulation, and laboratory testing, as well as testing for durability and stability.

For absolutely non-critical products (stand-alone software, dental drills, oral spatulas, etc.) and must be justified by the manufacturer based on risk management, in accordance with MDR Article 61 “Clinical Evaluation” Section 10.

The manufacturer’s claims, the anticipated clinical performance, and the precise interactions the device has with the human body are all taken into account in this explanation.

According to Annex II of the MDR, the manufacturer in this situation must explain in the technical documentation why they believe it is appropriate to show compliance with the general safety and performance requirements based solely on the outcomes of non-clinical test methods, including performance evaluation, technical testing, and pre-clinical evaluation.

Clinical Evaluation Plan (CEP)

A medical device’s clinical evaluation is a continuous process for developing, collecting, analysing, and evaluating clinical data. It is systematic and well-planned.

Manufacturers are required to create and update a clinical evaluation plan in accordance with Article 61 (paragraph 12) and Annex XIV Part A “Clinical Evaluation” of the MDR (CEP).

Basic ideas like the goals and format of the clinical evaluation are already stated in this strategy. The manufacturer establishes the fundamental performance and safety standards that relevant clinical data in the CEP must back up.

With detailed clinical outcome metrics, it outlines the desired clinical advantages for the patient and specifies the intended purpose, intended target groups, and explicit indications and contraindications.

A new required component of the clinical evaluation plan is a clinical development plan (CDP) for organising pertinently planned clinical trials, including a post-market clinical follow-up plan (PMCF plan).

These adjustments give clinical findings more weight. The Clinical Development Plan (CDP) explains how the manufacturer will gather new or extra clinical data through clinical trials or observational studies to solve open “gap analysis” problems at the beginning of the development phase.

Human volunteers are used in clinical trials to assess the clinical effectiveness and safety of medical equipment.

Class III Devices and Implantable Devices

Clinical investigations must always be carried out in the case of implanted devices and class III devices, with the following exceptions:

  • The already marketed device has been altered by the same manufacturer, who has also shown that the altered device is equivalent to the marketed one.
  • The notified body has approved of this demonstration, and the clinical assessment of the marketed device is sufficient to show that the altered device complies with the necessary safety and performance requirements.
  • Additionally, there is no requirement for clinical testing for class III and implantable devices if a manufacturer can show that its product is functionally equivalent to a product that has already been marketed, provided that the notified body has approved the demonstration and the following requirements are met.
  •  The two manufacturers have a contract in place that expressly grants the manufacturer of the second product full access to the technical documentation on a continuing basis, and the original device manufacturer is still in business.

Additionally, No obligation for clinical investigation for Class III and implantable devices:

  • If the devices have been legitimately marketed under previous directives, the clinical evaluation is supported by enough clinical data, and they adhere to Common specifications where they are available.

Annex XIV

A clinical evaluation must be planned, continually carried out, and documented by manufacturers in order to:

Create and maintain a clinical evaluation plan,

Utilising a systematic, scientific literature study, determine the clinical data that is available that is pertinent to the device and its intended use, as well as any gaps in the clinical evidence;

Evaluate each relevant clinical study’s applicability for proving the device’s performance and safety;

To produce any additional or new clinical data required to address unresolved problems through adequately conducted clinical research in accordance with the clinical development strategy; and

In order to conclude the safety and clinical performance of the device, including its clinical advantages, all pertinent clinical data must be examined.

Equivalence

Equivalence for the EU MDR clinical evaluation must be proven in two distinct ways.

Clinical

  • Used for the same clinical condition (with equivalent severity and stage of disease).
  • Utilised for the same medicinal purpose, and utilised for the same intended purposes, and
  • Utilised at the same body location, and used in a population with similar features (e.g., age, gender, anatomy, physiology, etc.), and not anticipated to produce noticeably differing performances (in the relevant critical performances such as the expected clinical effect, the specific intended purpose, the duration of use, etc.).

Technical

  • Have similar specifications and properties (e.g., physicochemical properties such as type and intensity of energy, tensile strength, viscosity, surface characteristics, wavelength, surface texture, porosity, particle size, nanotechnology, specific mass, atomic inclusions such as nitrocarburising, oxidability),
  • Similar design
  • Used under the same conditions, similar deployment methods (if applicable), and similar operating principles).

Biological

  • Use the same tools or substances when in contact with the same body fluids or human tissues.

FAQs

What do you mean by clinical evaluation?

A clinical evaluation is a systematic and well-planned procedure used to acquire, gather, analyse, and ultimately evaluate clinical data for a medical device.

What is clinical evidence?

Clinical evidence is defined as clinical data and clinical evaluation results about a device of sufficient amount and quality to permit a qualified assessment of whether the device is secure and provides the expected clinical benefit(s) when used in accordance with the manufacturer’s instructions.

The ‘Blue Guide’ on EU product rules implementation 2022 

The ‘Blue Guide’ on EU product rules implementation 2022 

The amended ‘Blue Guide’ on the application of the product rules 2022’ (“Blue Guide”) was released by the European Commission on June 29, 2022.

The Blue Guide allows a better understanding of EU product regulations and their uniform and coherent application across various sectors throughout the EU single market.

The Blue Guide has undergone significant changes, including the definition of new terms, the addition of information on which economic actors will be responsible for compliance in a complicated product supply chain, and the incorporation of Regulation (EU) 2019/1020 on market surveillance and product compliance.

Technical Documentation of The ‘Blue Guide’

The manufacturer must compile the technical documentation, including details proving the product complies with all relevant specifications.

If the law mandates a conformity assessment process based on a quality system, this paperwork may be a component of the quality system documentation.

Regardless of the product’s origin or location, technical documentation must be available when the product is put on the market.

The technical documentation must be preserved for ten years following the date the product was placed on the market. The manufacturer or the authorised representative based in the Union oversees this. 

The documentation must include 

  • Description of the product 
  • Intended use of the product
  • Design and manufacture of the product
  • Operation of the product

The requirements in Annex II of Decision No. 768/2008/EC concern the technical documentation necessary to demonstrate the product’s compliance with the relevant harmonisation legislation.

If only part of the harmonised standard is applied or does not cover all relevant essential requirements, then the way applicable essential requirements not covered by it are dealt with should be documented in the technical documentation.

The technical documentation must reflect all versions of the product, including the changes made, information on how the various conformity assessments can be identified, and information on how the different versions of the product can be identified to avoid scenarios in which, during a product’s life, a market surveillance authority must deal with product versions for which the technical documentation given to it does not apply.

Even if it isn’t explicitly stated in the Union harmonisation legislation, the documentation must always be in a language the notified body can understand.

EU Declaration of Conformity

As part of the conformity assessment process outlined in the Union harmonisation legislation, the manufacturer or the authorised representative formed within the Union must prepare and sign an EU Declaration of Conformity.

This document is required to show the product’s compliance with the applicable legislation requirements.

Unless the legislation specifies otherwise, the manufacturer must maintain the EU Declaration of Conformity for 10 years after the product is placed on the market. The importer is accountable for the Declaration of Conformity for products they have brought in.

It is necessary to keep the EU Declaration of Conformity updated. Even if they are produced in series, each product has its own EU Declaration of Conformity.

The version of the EU declaration of conformity must be updated for products put on the market after any modifications have been made to any elements of the EU declaration of conformity.

Either the model declaration found in Annex III of Decision No. 768/2008/EC or a model declaration directly annexed to the in question sectoral Union harmonisation legislation have to be referred to understand the contents in the EU Declaration of Conformity.

The declaration must include enough details to allow the identification of all the products it covers, whether in the form of a document, label, or equivalent.

To ease the administrative burden on economic operators, where multiple pieces of Union harmonisation legislation apply to a product, the manufacturer or the authorised agent must produce a single declaration of conformity.

The surveillance authority must access the EU declaration of conformity upon request. The declaration must always be made in the language(s) that the Member state(s) where the product is marketed requires.

Marking requirements

Before many products may be marketed on the European market, a CE Mark must be affixed to them. The label identifies a product as:

  • Complies with the relevant standards of European product directives
  • Satisfies all requirements outlined in Europe’s applicable, recognised, and harmonised performance and safety standards.
  • Appropriate for its intended use and won’t threaten people or property

The CE Mark is mandated conformity marking used by the European Union (EU) to control the sale of goods inside the European Economic Area (EEA).

A manufacturer certifies that their products conform with the EU’s New Approach Directives by placing the CE mark on them. These directives include products made in or intended for sale in the EEA and those sold in the EU. As a result, the CE symbol is identifiable everywhere, even by those unfamiliar with the EEA.

The manufacturer is ultimately in charge of the product’s compliance with the provisions of the Union harmonisation legislation and the use of the CE marking, regardless of whether they are based inside or outside the Union.

The manufacturer has the right to direct an authorised agent to apply the CE marking on his behalf. By placing the CE marking on a product, a manufacturer certifies that it complies with all applicable regulatory requirements for CE marking, on his sole responsibility.

Suppose the importer or distributor or another operator places products on the market under his name or trademark or modifies them. In that case, he then takes over the manufacturer’s responsibilities, including the responsibility of affixing the CE marking.

The definition, the format, and the general guidelines governing the CE marking are outlined in Regulation (EC) No. 765/2008. Procedures for conducting conformity assessments that result in its affixing are outlined in Decision No. 768/2008/EC.

The Regulation (EC) No 765/2008 and Decision No 768/2008/EC’s guiding principles are primarily upheld by the sectoral Union harmonisation legislation requiring the application of the CE marking.

If a notified body participates in the production control phase following the appropriate Union harmonisation law, its identification number must come after the CE marking.

If the legislation so demands, the manufacturer or the authorised agent must attach the identifying number under the supervision of the notified authority.

A notified body may participate in the production stage depending on the conformity evaluation techniques. Only if it engages in manufacturing must the notified body’s identification number come after the CE marking.

  CE marking appears on products without an identification number  CE marking appears on products with an identification number
Either no notified body intervened in the design or production phase (module A)Either upon manufacturer’s choice, a notified body intervened in the production phase (modules A1, A2)
Upon manufacturer’s choice, the in-house accredited body intervened in the production phase (modules A1, A2)A notified body intervened in the design phase (module B), and upon the manufacturer’s choice, a notified body (not necessarily the same one but the one whose identification number appears) intervened in the production phase (modules C1, C2 following module B)
A notified body intervened in the design phase (module B), but no notified body intervened in the production phase (module C following module B);  A notified body intervened in the design phase (module B), and a notified body (not necessarily the same one but the one whose identification number appears) intervened in the production phase (modules C1, C2, D, E, F following module B)
A notified body intervened in the design phase (module B), and upon the manufacturer’s choice, the in-house accredited body intervened in the production phase (modules C1, C2 following module B)A notified body intervened in the design and production phase (modules D1, E1, F1, G1 H, H1)

 

Modules for Conformity Assessment

A conformity assessment is any procedure by the manufacturer to evaluate a product, system, service, or perhaps even a person’s compliance with the standards and specifications outlined in a standard or specification.

Testing or inspection is frequently used for verification. Conformance assessments are performed on products during the design and manufacturing phases.

A conformity assessment procedure’s primary goal is to show that products that have been put on the market adhere to the standards set out in the existing legislation.

Conformity assessment processes comprise one or two conformity assessment modules under Union harmonisation legislation. A conformity assessment encompasses both the design and production phases since products are subject to conformity evaluation during both phases.

In contrast, a module may cover just one of the two phases or both. A “horizontal menu” of conformity assessment modules and how processes are constructed from modules is outlined in Decision No. 768/2008/EC.

Union harmonisation legislation creates conformity assessment processes either by foreclosing on the manufacturer’s options or by defining a range of options from which the manufacturer must select.

The manufacturer is responsible for conformity evaluation. However, a third party must be included in the compliance evaluation process if required by the applicable legislation.

FAQs

What is the significance of CE marking?

By applying the CE marking to a product, the manufacturer declares solely on his responsibility that the product complies with the essential requirements of the applicable Union harmonisation legislation requiring its application and that the relevant conformity assessment procedures have been completed. Products bearing the CE mark are presumed to comply with the applicable Union harmonisation legislation and thus have free circulation in the European Union.

Can I, as a manufacturer, personally affix the CE marking to my products?

After the required conformity assessment procedure has been completed, the manufacturer or his authorised representative can apply the CE marking. This means that the product must go through the conformity assessment procedure outlined in one or more of the relevant Union harmonisation acts before being given the CE marking and put on the market. The latter determines whether the manufacturer himself may conduct the conformity assessment or whether the involvement of a third party (the notified body) is necessary. The published ‘Blue guide’ helps product manufacturers understand how to place their products in conformity with the applicable product regulation.


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

Risk Management of medical devices under MDR

Risk Management of medical devices under MDR

All medical devices are associated with inherent risks of some level. It is imperative to understand the medical device’s specific risks to a patient. Under EU MDR 2017/745, risk management is a continuous and iterative process.

Manufacturers are expected to plan, document, and implement risk management strategies in this process. These strategies may either eliminate the risk or mitigate the overall severity of the risk.

Medical Device Risk- Definition      

As per Article II of EU MDR 2017/745, medical device risk is defined as ‘the combination of the probability of occurrence of harm and the severity of that harm’.

According to the definition, the strategies help prevent particular harm or risk and prevent severe harm.

Risk Management under MDR

Annex I section 3 of EU MDR 2017/745 mentions its requirements specific to the European medical device regulations. Manufacturers, under MDR, must implement the following aspects of risk management to be fully compliant.

  • Establish and document its plan for each device
  • Identify the known and foreseeable hazards associated with the device
  • Estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse
  • Eliminate or control the risks 
  • Evaluate the impact of information from the production phase to the post-market phase on hazards and the frequency of occurrence of associated risks, the overall risk, benefit-risk ratio, and risk acceptability
  • Amend risk control measures if necessary

While implementing risk control measures to design and manufacture devices, the following aspects must be considered. Manufacturers must:

  • Eliminate risks through safe design and manufacture of the device
  • Take adequate protection measures (such as including alarms) if the risks cannot be eliminated
  • Provide information for safety (warnings/precautions/contra-indications) and training to users.

Certain medical device risks may be due to device usage errors. In Annex I Chapter I, MDR clearly states that such risks can be prevented by:

  • Reducing risks related to the ergonomic features of the device and the environment in which it is intended for use
  • Consideration of technical knowledge, experience, education, training and use environment, and the medical and physical conditions of intended users

How are device risks managed?

Risk management can be considered a 5-step procedure.

Step 1: Risk management plan

All these activities must be planned. The plan lays forth a strategy for risk management activities to be carried out throughout the product lifecycle.

This plan is documented in a risk management file containing the risk management plan and a risk management report.

Step 2: Risk assessments

Risk assessments evaluate the risk identified in normal and abnormal medical device use. Normal use of a medical device is the intended application of the device following all instructions by the manufacturer.

In contrast, abnormal use is when the medical device was used, violating the device instructions.

Step 3: Risk Control

Risks are controlled by implementing its plan. The risk-control measures chosen must be executed, and their effectiveness must be validated. This is done for an effective quality management system.

Step 4: Evaluation of residual risks

Complete elimination of risk may not be possible all the time. Therefore, it is imperative to identify the residual risk so that small and expected rather than massive, unexpected risks.

Step 5: Risk management review

As risk management is an iterative process, reviewing the risk control measures adopted and their effectiveness is imperative. This is ensured by post-market surveillance systems, clinical evaluation, and vigilance systems.

Maintaining updated risk systems and documents constitutes an effective quality management system for any medical device.

FAQs

How are risks categorised?

Risks are classified based on the occurrence and severity of harm caused. The figure below is a risk matrix used to illustrate a matrix on all foreseeable risks. This is useful for evaluating residual risks posed by the medical device on the patient.

What is the EU MDR harmonized standard adopted for Risk Management?

EU MDR has adopted ISO 14971 for the Application of risk management to medical devices. This ISO standard allows manufacturers to identify hazards of a medical device and implement control measures for the same.

What is the role of Risk management in a clinical evaluation procedure?

Clinical evaluation is imperative to risk management as this allows the manufacturer to identify all possible risks associated with the device. This data can be used for the identification of safety concerns and appropriate risk management methods can be implanted. In other words, clinical evaluation is one of the inputs to risk management.


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