MDCG Guidance for Manufacturers of Class I Medical Devices

MDCG Guidance for Manufacturers of Class I Medical Devices

A medical device’s intended use and inherent risks must be considered when determining its MDR classification. Class I devices pose less risk to patients and end users, as under the previous MDD. The new Regulation EU MDR 2017/745 has added extended rules, leading some devices to fall under Class IIa, IIb, or even III. 

This document is intended to guide Class I medical device manufacturers (excluding custom-made devices) that sell products bearing their name or trademark on the Union market to comply with MDR requirements. This guidance should also apply when an importer, distributor, or any other legal entity takes on the obligations owed by manufacturers.

The class I manufacturer must also hire a Notified Body (NB) to perform a conformity evaluation if medical devices are to be provided sterile, have measuring functions, or are reusable surgical instruments. For the NB to be qualified to conduct such a conformity assessment, the specific medical device in question must come within the purview of the Notified Body’s designation.

Large and mid-sized medical device manufacturers must also properly designate at least one individual in charge of regulatory compliance, but micro and small companies can function better by having a regulatory expert.

It is also important to designate an authorised representative residing within the EU if the manufacturer is registered outside of the EU. A foreign manufacturer must specifically issue a mandate outlining the representative’s duties and authority. It is also crucial to note that not all responsibilities associated with the medical equipment can be assigned.

The manufacturer must adequately preserve all the records required to verify compliance with the relevant requirements so they may be made available to the regulatory body upon request.

Steps to placing Class I medical devices on the market:

Manufacturers must ensure compliance with each of the following requirements if they plan to commercialise Class I medical devices. Please be aware that some of the outlined requirements are interconnected and can be completed in a different sequence than that which is shown.

The manufacturer will carry out a gap analysis for Class I devices that have already been released onto the market in compliance with the MDD to ensure that all of the below-listed requirements were satisfied at the time the MDR was applied.

The whole procedure includes a set of mandatory steps, including:

Step 0: Integrate MDR in the Quality Management System (QMS)

The manufacturer’s QMS should be appropriately linked with the standards outlined in the MDR. To ensure compliance with the following requirements, this will enable the correct assessment or decision to be taken and the appropriate documented evidence to be produced.

Step 1: Confirm product as a medical device

The intended purpose and the product’s mode of action are reviewed as per Article 2(1) of the MDR to ensure that the product qualifies as a medical device. If a product is assigned multiple intended purposes, it will qualify as a medical device only if all the intended purposes are covered in Article 2(1). In the case of products identified as more than one category, the relevant legislation requirements will have to be followed. Despite not being medical devices in and of themselves, accessories to medical devices are subject to MDR regulations and qualify as devices under the MDR definition. However, the MDR does not include accessories to devices covered by it as per Annex XVI of the MDR.

Step 2: Confirm product as a Class I medical device

The product has to be confirmed if it can be classified as a class I device as per Annex VIII of the MDR. Products previously classified as class I under MDD should be reviewed according to the classification rules of MDR to confirm if reclassification is required. The MDD guideline cannot be used for devices that were moved from Class I to higher risk classes by the adoption of the MDR. The intended use of the device and any inherent risks related to the period of use, the part of the body, whether it is active or not, and whether it is invasive or non-invasive will determine how the classification standards are applied. The classification rule with the highest class should be applied if the device in question falls under the purview of more than one classification rule due to its attributes.

Step 3: Procedures before placing on the market

a)   Meet the General Safety and Performance Requirements (GSPR)

The devices will adhere to the general safety and performance standards outlined in Annex I of the MDR, considering the intended purposes that their manufacturers had provided. The Risk management system is a continuous iterative process throughout the entire lifecycle of the product, established by the manufacturer that will enable the identification and analysis of the risks related to each device, the estimation and assessment of the risks associated with those risks, the elimination or control of residual risks, and the evaluation of the adopted measures based on the data gathered from the PMS system.  

When a harmonised standard is in place, but a manufacturer chooses to use another reference, implementing that reference should, at the very least, ensure the same level of performance and safety. Compliance with the relevant harmonised standards will give rise to a presumption that the MDR’s requirements, or portions of them, are also complied with. If there are available standard specifications, the manufacturer must adhere to them unless they can adequately demonstrate that they have chosen a solution at least as effective and safe. The clinical evaluation processes, risk management, and PMS must be interdependent and updated regularly.

b)   Conduct clinical evaluation

As part of the MDR’s technical documentation requirements, all devices—regardless of risk classification—require a clinical evaluation. The level of clinical evidence required to show compliance with the pertinent general safety and performance requirements listed in Annex I, which is obtained by considering the characteristics of the device and its intended purpose, shall be specified, and justified by the manufacturer. Manufacturers must prepare, carry out, and record a clinical evaluation in compliance with Article 61 and Part A of Annex XIV to accomplish this.

Conformity to Annex I requirements can only be assumed when the following items are aligned with each other.

Consideration of available alternative treatment options, the incorporation of clinical data and the acceptability of the benefit-risk ratio are required for carrying out a clinical evaluation.

Additional clinical data will be acquired or developed by clinical investigations if the currently available clinical data are insufficient to establish compliance with the MDR. If the clinical data currently available for a device that is currently certified under Directive 93/42/EC is insufficient to show compliance with MDR, then post-market clinical follow-up studies of the device may be used to gather more clinical data. Even data from the general post-market follow-up may occasionally be enough to close the difference.

a)   Prepare technical documentation

The manufacturer is responsible for creating and maintaining the technical documentation to prove that their products adhere to the MDR’s technical specifications. Under Annex II and III, this technical documentation must be prepared before the EU declaration of compliance is drawn.

The manufacturer will develop and provide the technical documentation and, if applicable, it’s summary in a way that is unambiguous, clear, well-organised, and easy to search. The manufacturer shall provide the CA, the authorised representative (where applicable), and NB with access to the technical documents (when applicable). After reviewing the general safety and performance standards, as well as the pertinent technical provisions of the MDR, the technical documentation will be developed.

b)   Request Notified Body involvement

Class I devices do not require the engagement of an NB for MDR compliance. But the manufacturer must follow the guidelines outlined in Chapters I and III of Annex IX or Part A of Annex XI of MDR when the product is a sterile equipment, measuring instrument, or reusable surgical tools.

For the relevant codes and corresponding types of devices as established by Regulation (EU) 2017/2185, manufacturers may select any NB designated in accordance with the MDR.

c)    Prepare Instructions for Use and Labelling

Any safety and performance information required for a device’s safe usage and identification of the device should be provided along with the device by the manufacturer and/or the authorised representative, considering the possible users’ training and knowledge. This data is included on the label, in the device packing, and in the instructions for use. Class I devices do not need instructions for use if they may be operated effectively and securely without them, deviating from the general rule. Since Class Ir devices will need instructions for reprocessing (cleaning and sterilisation), an exception is most likely proposed.

Labelling and instructions for use must be written in accordance with national language regulations. There will be versions of the labelling and IFU in the technical documentation (in each pertinent national language). The requirements regarding the information to be supplied with the device will be found in Annex I, Chapter III (23).

Step 4: Check compliance with general obligations for manufacturers

The manufacturer shall ensure that the general obligations for manufacturers outlined in Article 10 are met before releasing a device for sale.

Implementing a suitable QMS that will most effectively assure compliance with the MDR, such as through an internal audit, will receive special consideration. The QMS shall be documented, applied, maintained, updated regularly, and developed continuously, and it will at least include the following elements:

  • A strategy for regulatory compliance
  • Identification of applicable general safety and performance requirements and exploration of options to address those requirements
  • Responsibility of the management
  • Resource management, including selection and control of suppliers and sub-contractors
  • Risk management
  • Clinical evaluation, including post-market clinical follow-up (PMCF)
  • Product realisation, including planning, design, development, production and service provision
  • Verification of the UDI assignments
  • Setting up, implementation and maintenance of a post-market surveillance system
  • Handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders
  • Processes for reporting serious incidents and field safety corrective actions in the context of vigilance
  • Management of corrective and preventive actions and verification of their effectiveness
  • Processes for monitoring and measurement of output, data analysis and product improvement.

According to applicable Union and national law, either natural or legal persons may seek compensation for harm brought on by a defective equipment. In order to protect themselves against potential responsibility under Directive 85/374/EEC, manufacturers must take precautions that are commensurate to the risk class, type of device, and size of the business. These steps must not compromise further protective measures under national legislation.

Step 5: Draw-up the EU Declaration of Conformity

The process by which the manufacturer, who complies with the standards established by Article 52(7), certifies that the devices in question comply with the requirements of the MDR that apply to them is referred to in Article 19 as the EU declaration of conformity. The CA will have access to the declaration of compliance, which must include, at a minimum, all of the data referred to in Annex IV. The manufacturer will regularly update the EU declaration of conformity and translate it into the official language(s) required by the Member States where the product is sold.

Suppose a device is subject to additional Union laws in addition to the MDR that also call for an EU declaration of conformity. In that case, the manufacturers will create a single EU declaration of conformity that refers to all applicable Union laws.

By creating the EU declaration of conformity, the manufacturer accepts liability for the device’s regulatory compliance with all relevant Union legislation.

For class Ir, Im, and Is devices, the manufacturer must obtain an EC certificate from NB per Annex IX, Chapters I and III, or Annex XI, Part A before applying a CE mark.

Step 6: Affix the CE marking

All Class I medical devices on the market must display the CE conformity label, which must be visible, readable, and permanent. It may be applied to the item or its sterile packaging. The CE marking must be applied to the package in cases where such affixing is impossible or unwarranted due to the nature of the device. The CE certification must be visible on all sales packaging and the instructions for use.

Placing the CE mark on a medical device signifies that it complies with all applicable safety and performance standards and is approved for marketing in the EU. The CE marking will be accompanied by the identification number of the relevant NB in the case of Class I medical devices placed on the market in a sterile condition, devices with measurement functions, and/or reusable surgical tools.

Affixing marks that could lead third parties astray about the significance of the CE marking is banned. Other extra markings may be applied to the product, the packaging, or the usage instructions, but they must not obscure or obstruct the CE marking.

The CE marking format will follow Annex V requirements. The minimum dimensions required for the CE mark may not apply to very small devices.

Step 7: Registration of devices and manufacturers in Eudamed

A streamlined approach might be used for medical devices that were previously put on the market per the Directives, provided that the manufacturer evaluates the gap and ensures that all regulations are properly followed.

A Class I medical device manufacturer must register the product with Eudamed before putting it on the market. Suppose the information listed in Section 1 of Part A of Annex VI has not already been registered in accordance with Article 31. In that case, the manufacturer must submit it to the electronic system in order to register the device. The information referred to in Section 1 of Part A of Annex VI will be given to that electronic system before applying to the NB in situations where the conformity assessment method necessitates the engagement of an NB in accordance with Article 52.

Following the CA’s validation of the manufacturer’s data in Eudamed, the manufacturer will receive an SRN from the aforementioned electronic system. To fulfil its duties under Article 29, the manufacturer will use the SRN when submitting an application to an NB for a conformity assessment and to gain access to Eudamed.

The registration of a device in Eudamed by the manufacturer includes:

  • Assigning a UDI-DI (with a Basic UDI-DI) as described in Part C of Annex VI to the device in accordance with the issuing entity’s policies mentioned in Article 27(2) and adding the UDI-DI (with a Basic UDI-DI) to the UDI database along with the other core data elements pertaining to that device mentioned in Part B of Annex VI.
  • Entering the data referred to in Section 2 of Part A of Annex VI, excluding Section 2.2 thereof, or, if previously provided, validating the data, and then keeping the data current up to date.

This document summarises the information presented above and outlines how Class I medical devices should be introduced to the EU market. The guidance’s scope also includes reusable surgical instruments (Class Ir), sterile medical devices (Class Is), and devices with measurement capabilities. These medical devices all need a Notified Body to be involved in pre-marketing procedures.

Registration of Legacy Devices in EUDAMED

Registration of Legacy Devices in EUDAMED

Legacy Devices are the medical devices covered by a valid Directive certificate under Directive 93/42/EEC or Directive 90/385/EEC and continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR). Those devices should be registered under EUDAMED without Basic UDI-DI and a UDI-DI within 18 months after the application is placed or 24 months if the EUDAMED is not fully functional before the date of application. This registration is mandatory for the manufacturer in case of any serious incidents and if any field safety actions have been taken, at least before the final vigilance report is submitted.

As per MDR device requirements, any medical device registered under EUDAMED will require Basic UDI-DI and UDI-DI, which gets reflected on the database design for future reference.

These legacy devices will need two other unique access keys (UI) to replace basic UDI-DI and UDI-DI to register under EUDAMED. Instead of Basic UDI-DI, the legacy devices will be assigned EUDAMED DI, and instead of UDI-DI, the legacy devices will be assigned EUDAMED ID.

As per the flowchart above, 

  • If the manufacturer already has UDI-DI assigned to the legacy device, then the EUDAMED DI will be automatically generated based on UDI-DI in the standard format, placing the character “B-“ in front of UDI-DI
  • If the manufacturer does not have an assigned UDI-DI for the legacy device, then they will be assigned both EUDAMED DI and EUDAMED ID

The EUDAMED DI can be completely assigned by the EUDAMED or partially taken from the manufacturer using their DI code. But the EUDAMED ID should be completely generated by the EUDAMED. The EUDAMED DI will start with the character “B”, whereas the EUDAMED ID will start with the character “D” other than the first character EUDAMED DI and the ID will include the SRN number, a number assigned to the manufacturer and check digit. In addition, the manufacturer should enter their directive certificate identification, such as NB number, revision number, certificate number, and expiry date.

EUDAMED allows the linking of the regulation device with the legacy devices, if the regulation device is exactly the same as the legacy device, they can have the same UDI-DI. This link may happen automatically by EUDAMED, or the manufacturer can create a link manually by assigning a legacy device identifier, which should happen at the level of UDI-DI.

FAQ

What is the difference between Basic UDI-DI and a UDI-DI?

Basic UDI-DI is a DI assigned to the level of unit use of the device, which is a primary identifier for the device model/family . It is mentioned in the reference CE certificates and the Declaration of Conformity. In contrast, UDI-DI is a unique numeric or alphanumeric code of each device itself , which is used as an access key for the UDI database.

What is EUDAMED?

EUDAMED is a European Database of Medical devices operated by the European Commission to register relevant information on medical devices and to ensure the medical devices’ safety, traceability, and transparency as per MDR 2017/745.

When can a manufacturer register under EUDAMED?

The manufacturer can register their device information/UDI voluntarily in EUDAMED. Moreover, it is mandatory to register legacy and regulatory devices within 24 months after the Commission publishes that the EUDAMED is completely functional.

Vigilance in EU MDR

Vigilance in EU MDR

Introduction

The Medical Device Vigilance System’s goal is to lower the risks of using medical equipment and serious incidents while it strives to improve protection for patients, healthcare providers, and other users. A National Competent Authority Report is one way that adverse occurrences are evaluated and, where necessary, information is shared according to the Medical Devices Directives/Regulations (NCAR). The implementation of suitable field safety corrective measures aims to prevent the repetition of such events. To facilitate and harmonise the execution of the EU regulations on Medical Devices by manufacturers and competent authorities, general recommendations on vigilance are added to the Medical Devices Regulations.

Manufacturers of medical devices are obligated by law to report adverse incidents and Field Safety Corrective Actions (FSCAs) to EU Competent Authorities in accordance with the European Medical Devices Regulations and the In-Vitro Diagnostic Devices Regulations. Regulators are frequently perplexed by the “when, what, and to whom” part of EU incident reporting. Companies that disclose incidents incorrectly risk serious repercussions. RA professionals must take the initiative because ignorance is not a valid justification for failing to report problems.

Requirements for Vigilance Reporting According to EU MDR 2017/745

The following events are considered as “reportable events” in accordance with the new EU MDR when they directly involve a medical device:

  • The event resulted in death or a severe decline of the health of the patient, user, or any other person involved.
  • Although the specific event had no adverse effects on any individual, it could result in death or a severe decline of the health of the patient, user, or any other individual if it were to occur again. The manufacturer is responsible for determining whether a given occurrence could seriously impact a patient or user; this assessment must be based on risk management and a medical examination of the particular event.

The Timeline For Vigilance Reporting (as per MDR ARTICLE 87)

  • Events that pose a serious risk to public health must be notified immediately but no later than two days after becoming aware of them.
  • Events involving the death of a patient, a user, or any other person, or the serious deterioration of their health, must be notified immediately but no later than 10 days after becoming aware of them.
  • Events that had little or no impact on the patient or user but were likely to result in death or a major decline in health if they happened again must be reported right away but no later than 15 days after becoming aware of them.

When are EU vigilance reports necessary?

In accordance with MEDDEV 2.12/1, an incident report must be made if a device malfunction, decline in device performance, inadequate instructions, or inadequate labelling results in death or serious injury, or if it could result in death or serious deterioration of state of health if it were to occur again. The incident has to be notified to the member state’s Competent Authority (CA), depending on where it happened.

In Europe, below are the fundamental procedures to report an incident:

  • The appropriate reporting deadline, which will depend on the severity of the incident, can be found in MEDDEV 2.12/1.
  • Notify the relevant Competent Authorities of the incident.
  • Respond to Competent Authorities’ inquiries on the devices implicated, their time on the market, and any design alterations.
  • Appropriate communication with the Competent Authorities and determine whether a Field Safety Corrective Action (FSCA) and Field Safety Notice (FSN) are required.
  • Send a Final Incident Report or a FSCA Report to the appropriate authorities.
  • Include vigilance reports in ISO 13485 or equivalent quality system records and any correspondence with Competent Authorities.
  • Unless Class 1 self-certified, report any accidents or FSCAs to the respective Notified Body.

Vigilance as per EU MDR compared to the MDD

It was challenging to distinguish between Vigilance and PMS in the Medical Device Directive (MDD). In the European Union Medical Device Regulation (EU MDR), a distinction is made between “post-market surveillance” (PMS), which is the periodic reconfirmation that the benefits of the device continue to outweigh its risks, and “vigilance,” which is the identification, reporting, and trending of serious incidents and the conduct of safety-related corrective actions.

The 10-day limit for reporting a death or a major health deterioration and the 2-day reporting deadline for serious threats to the public’s health have not changed since the MDD. The MDD’s 30-day reporting deadline for all other reportable occurrences is replaced by a 15-day reporting deadline for all other major incidents.

When the frequency or seriousness of additional incidents significantly increases, the EU MDR also mandates vigilance reporting. As opposed to the MDD, trend reporting (Article 88) and analysis (Article 89) were already directed by MEDDEV 2.12/1 and had been anticipated by European Competent Authorities and Notified Bodies for some time.

The necessity to submit vigilance reports to the EUDAMED database (Article 92), as opposed to each national Competent Authority, as required under the MDD, is a new requirement in the EU MDR. The national vigilance reporting methods will continue to be used, though, until the vigilance module of EUDAMED is available.

FAQs

To Whom Should Medical Device-Related Incidents Be Reported?

Medical device-related adverse events must be reported to the relevant national competent authorities where they occurred.

EU IVDR’s First certification for the type of IVD and Notified bodies procedures

EU IVDR’s First certification for the type of IVD and Notified bodies procedures

A short article based on MDCG 2021-22 guidelines on “first certification for the type of devices and the corresponding procedures to be followed by the Notified Bodies, ” established based on Article 106 of Regulation 2017/745  for Class D IVDR devices.

Additionally, this guide talks about the conditions to be followed by the Notified bodies, whether to consult the expert panel for the performance evaluation report of the IVDR devices.

  • If the type of the device comes under the first certification in the market (AND)
  • There is no CS for the class D devices.

According to Article 48(6) of IVDR 2017/746, the first certification for the type of device means that the product has no similar product with the same intended use or technology around the European market. Also, the notified bodies should submit the performance evaluation report to the expert panel within five days of receiving it from the manufacturer. The same intended purposes include

  • Device functions like monitoring, diagnosing, screening etc.
  • If the device is quantitative, semi-quantitative or qualitative
  • It is automated or semi-automated, or not
  • If it is used for any measurement
  • If the device is used for any specific disorder
  • What is the specimen type, or if it is applicable for some testing purpose
  • What all the intended users
  • Or if the device has the same principle of operation

Suppose the device has met the above-mentioned purposes under Directive 98/79/EC or has an ongoing consultation with the expert panel under EU 2017/746. In such case, the notified bodies need not consult the expert panel for the certification.

However, if the class D device is with similar intended purpose but one of the devices has some additional intended purpose along with the common intended purpose, which falls outside Rule 1 or 2 of IVDR Annex VIII then, this type of device should be considered under the “type of device” while consulting the expert panel.

Other examples for the same type of purposes include

  • Automated and semi-automated devices
  • Technologies
  • Multiplex and single analyte devices
  • Kits and class D components of those kits
  • Control materials

Hence, the notified body issuing the certificate should check if the product meets the criteria stated above to classify it as the “type of device” for the first time. For the final decision, they can use their knowledge and expertise, consider the information provided by the manufacturer, or if the device has already undergone an expert panel consultation. Post assessments, if the notified bodies decide that the product is given the first certification, they need to consult the expert panel and document the certification with the conclusion.

Table

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Fig 1: Notified body template for the expert consultation 

If the expert panel has been kept in consultation for the first certification of the IVDR device, the notified body cannot issue the second or third certificate without considering the views of the expert panel on the type of device. 

What are class D IVDR devices? 

Class D devices are high-risk devices, including devices used for blood screening for grouping, to screen cells & organs to manage infectious outbreaks or for transplantation. 

What is an expert panel? 

Expert panel advisors are appointed by the EU commission who can provide scientific, technical, and clinical evaluation guidance for high-risk devices and their performances. 

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

EU MDR Market Surveillance Activities

EU MDR Market Surveillance Activities

Market surveillance is the activity carried out by the competent authorities according to Article 93 of MDR 2017/745 to ensure that products on the market comply with the relevant laws and regulations and with the current EU health and safety requirements. Maintaining market security in Europe and promoting consumer safety and business trust is vital.

Suppose the medical device poses an unacceptable risk to the health or safety of the patients, users, or other people or any other aspects of the protection of public health. In that case, the competent authorities shall immediately require the manufacturer of the medical devices concerned, its authorized representative (AR), and all other relevant economic operators to take appropriate and duly justified corrective actions to bring the device into compliance with the MDR Regulation or withdraw or recall the medical device from the market.

Depending on the severity of the incident, the regulatory authorities require reports of serious adverse events or accidents to be submitted within 48 hours to 15 days. The most crucial aspect of market surveillance efforts is the evaluation and examination of the adverse event or incidence investigation reports, risk management reports, and vigilance data from medical device manufacturers and consumers.

If they disagree with the national legislation notified, they must immediately communicate their complaints to the European Commission and the other Member States via the electronic system referred to in Article 100 of MDR. Any measures taken by a Member State that has not been objected to by either a Member State or the Commission within two months of receiving the notification are justified.

If necessary, the authority may start a public field safety corrective action (FSCA). For significant product non-conformities, the responsible authority must evaluate if further regulatory action is necessary, which can be taken by destroying hazardous or non-compliant products, confiscating medical equipment, or assisting the manufacturer in bringing the product back into compliance with the law.

Obligations of the competent authorities are

  • Monitoring devices and incidents that occur while using them
  • Analyzing market data and identifying the possible potential issues
  • Reviewing technical documentation
  • Identifying unsafe or non-compliant medical devices
  • Reactively or proactively inspecting economic operator facilities
  • Removing unsafe devices from the market

The competent authorities shall develop annual surveillance activity plans and allocate adequate materials and qualified human resources to carry out those activities above. Also, they shall prepare a summary of the surveillance activities performed with the required corrective action to be set out by the economic operators and make them available on the electronic system.

The Member States will review and evaluate the effectiveness of their market surveillance efforts, which are carried out at least every four years, and be informed to the Commission and other Member States of their outcomes. Each Member State must summarise the results available to the public via the electronic system, as mentioned in Article 100 of MDR 2017/745.

The electronic system EUDAMED shall collate and process the following information on market surveillance.

  • Surveillance activity results
  • Final inspection report
  • Unacceptable risks associated with the medical devices
  • Non- compliance product information
  • Results of reviews and assessments carried out by the Member states on market surveillance.

To ensure a high-quality and uniform level of market surveillance across all Member States, the competent authorities must coordinate their market surveillance efforts through joint market surveillance activities, work together, and share their results with one another and the Commission.

What is the difference between Post-market Surveillance (PMS) and Market Surveillance?

Market surveillance is the same as post-market monitoring, where they make sure that medical devices sold on the EU market are safe, effective, and compliant. Market monitoring is conducted by the appropriate competent authorities, whereas the manufacturer of the medical devices carries out PMS.

What is the role of vigilance in market surveillance activities?

Vigilance focuses on reporting serious adverse events or accidents and field safety corrective actions (FSCA). In contrast, market surveillance is entirely concerned with developing procedures that can ensure the compliance of medical devices.

Any serious incident involving a device marketed and sold in the European Union and any field safety remedial action carried out in the EU or other markets where the device is sold should be made available in EUDAMED.

What is a joint action of market surveillance?

The Joint Action on Market Surveillance of Medical Devices (JAMS) is created to strengthen market surveillance across European member states. The medical device industry carries out best practices, education, information, and resources to improve public health protection. Critical goals include enhancing coordination and assisting member states with limited resources in building their capacities and skills in the market surveillance network. It will facilitate the creation of clinical processes, equivalent resources, and a consistent and balanced approach to manufacturer inspections.

MDCG 2022-16 Guidance for Authorised Representatives (AR)

Article 11 of the Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) outlines the obligations and responsibilities for the Authorised Representative (AR).

Key points are taken in accordance with the guidance:

  1. A ‘sole’ authorised representative means a manufacturer can have more than one AR for different generic device groups. However, for one specific generic device group, the manufacturer should designate only one AR.
  2. On behalf of the manufacturer, AR can lodge an application for conformity assessment according to Annex IX, X, XI MDR/IVDR with a notified body at the pre-market stage.
  3. AR who terminates the mandate may still cooperate with the competent authority for devices which was designated by them, particularly when no new AR has yet been designated for those devices.
  4. AR must be registered under EUDAMED as per Section 1 of Part A of Annex VI of the Regulations, which needs to be updated within one week of any change occurring and the accuracy of the data at intervals no later than one year after the initial submission of the information, and every second year thereafter.
  5. AR name shall appear on relevant documentation such as the EU DoC (Declaration of Conformity) and device labelling by the manufacturer.
  6. The legal representative established by the sponsor of the clinical investigation or performance study is not defined under the AR requirements.
  7. AR shall keep a copy of the technical documentation and the EU declaration of conformity for at least ten years after the last device covered by the EU DoC and 15 years for implantable devices.
  8. ‘Permanently available’ means it is mandatory for the manufacturer to provide the requisite documentation in their most recent versions and certificates. This includes amendments or supplements, either in hard or electronic copy to the AR. In practical terms having permanent access to such documents.
  9. When the liability of the AR is alleged within the framework of a specific legal regime for defective products, the AR is afforded the same rights to defend itself as the manufacturer under that regime.
  10. In the event of a problematic termination like non-compliance or non-traceability with the manufacturer, the out-going AR is also advised to inform the competent authorities and, where applicable, the notified body.
  11. In general, a tripartite agreement should exist, except in cases where this is ‘not practicable’ to involve the outgoing AR, the obligation under Article 12(d) to forward complaints to the manufacturer or incoming AR should apply.
  12. AR may be consulted for market surveillance measures taken by competent authorities to make documentation and information available to them. Also, AR may be subject to announced and unannounced inspections by the competent authorities as part of their market surveillance activities which is also covered for the legacy devices.