Market Surveillance of Medical Devices Under the EU MDR
The term market surveillance covers the activities carried out by national regulatory authorities to ensure the safety and efficiency of products placed on the market. In these activities, the national regulatory authorities put measures in place to verify and guarantee the regulatory compliance of products and to establish processes and appropriate measures for diminishing the risk of non-compliant products.
Medical devices in the European Union market must comply with article 93 of the Medical Device Regulation (MDR; 2017/745) and article 88 of the In Vitro Diagnostic Regulation (IVDR; 2017/746).
In this article, we review market surveillance as defined and required in the MDR. As the MDR and IVDR are extremely similar in this regard, even though only the MDR is discussed, it can be assumed that everything here also applies for in vitro diagnostic devices.
Even though they are not necessarily the same, competent authority and regulatory authority will be used interchangeably.
Market surveillance of medical devices in the European Union
Market surveillance is defined in the MDR as “…the activities carried out and measures taken by regulatory authorities to check and ensure that devices comply with the requirements set out in the relevant European Union harmonization legislation and do not endanger health, safety or any other aspect of public interest protection;” Article 93 of the MDR further outlines the market surveillance responsibilities of each regulatory authority.
Conformity and performance assessment
Every competent authority, i.e., every designated government department for an EU member state, must check the conformity characteristics and performance of the devices manufactured or available in their market. They should mainly consider risk assessment and management, vigilance data, and complaints when doing so.
This means making sure the economic operators of the products gather the documentation and information necessary to confirm the product’s conformity and make it available to the authorities. It also means that economic operators, such as manufacturers or importers, must provide the necessary medical device samples for testing, free of charge if required by the authorities.
The competent authority must perform announced and, if required, unannounced inspections of production lines, warehouses, and other facilities used by the economic operators to produce and distribute their medical devices. The inspections must be documented in reports summarizing the findings of the inspection and set out any corrective actions if needed. This report is made available to the economic operator subject to the inspection, and before finalizing and adopting the report, the economic operator has the opportunity to submit comments. Once finalized, the report is uploaded to EUDAMED (we’ll discuss EUDAMED later).
Annual surveillance activities
Similar to medical device manufacturers, they must establish a post-market surveillance system that includes a timely elaboration of post-market surveillance reports, vigilance data, and summaries of the activities they are pursuing to ensure their medical device complies with the current regulation. It is safe and efficient for patients and users; competent authorities are also required to draw up surveillance plans and reports.
Each regulatory authority is obligated to establish and maintain annual surveillance activity plans under the MDR. The surveillance activities carried out must also be summarized yearly and be made accessible to other competent/regulatory authorities through EUDAMED.
Likewise, the regulatory authority must allocate materials and human resources to carry out these activities.
Non-compliant medical devices
Even though medical device manufacturers do everything to ensure the safety of their devices, adverse events and malfunctions are bound to happen. Off-label use, unexpected errors, and faulty servicing or training happen to even the most tested medical devices.
The main job of the competent authority is to protect public health. Therefore, they must confiscate, destroy, or otherwise render inoperable devices that pose an unacceptable risk to the patient or user. Likewise, they are obligated to confiscate and destroy any falsified medical devices, or in vitro diagnostic devices they come across in their market.
Sharing information across borders in the European Union
The European Union market consists of many different cultures and countries. Therefore, in order to ensure the protection of public health in each country, an effort to communicate and coordinate activities across borders is necessary.
After reviewing and assessing the functioning of their market surveillance activities, the MDR requires each Member State to make a summary of their results and make it available to the other member states through EUDAMED.
Likewise, each regulatory authority must coordinate its market surveillance activities with other member states to “provide for a harmonized and high level of market surveillance in all Member States” (article 93.9). The authorities must also share their work, join their market surveillance activities and specializations, and share information where appropriate.
Lastly, the member states are also responsible for cooperation with competent authorities in countries or markets outside the European Union, exchanging information and technical support whenever needed.
EUDAMED is the European Databank on Medical Devices, created in May 2011 to strengthen market surveillance and transparency regarding devices placed on the European market. It is a secure, web-based portal acting as a central place the national competent authorities and the European Commission can share information. It cannot be accessed by the general public. EUDAMED provides the competent authorities of the EU member states with a database of relevant regulatory information and functions as an implementation aid for the MDR and its market and post-market surveillance system.
Depending on the classification of a medical device and which regulations and provisions it falls under, EUDAMED contains the following relevant data, where applicable:
- Quality Management System certificates
- Labeling and instructions for use
- Declarations of conformity
- Vigilance and traceability systems
- Registration of manufacturer, authorized representative, and device data lists
- Classification justification
- Clinical investigation data
- Any other information required for the device
As a medical device manufacturer, it might seem overwhelming to have to comply with the level of detail and requirements set out for your post-market surveillance system under the MDR, not to mention the burdens of incorporating post-market surveillance data into risk management, clinical evaluation, and post-market clinical follow-up documentation.
However, the national competent authorities in each Member State of the European Union are required by the MDR to perform many of the same actions as a medical device manufacturer, albeit on a larger scale, for market surveillance. Each authority is in charge of establishing a market surveillance process fitted to their market, delivering annual summaries of market surveillance activities, and coordinating and cooperating with other competent authorities to ensure the health of their population.