FAQs on Medical Device Regulation (MDR)

The EU's Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into force on 25 May 2017. The MDR replaced the EU’s Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).

Here are some frequently asked questions about the MDR and TÜV SÜD’s MDR services.

1. WHAT IS THE MEDICAL DEVICE REGULATION (MDR)?

The Medical Device Regulation (MDR) replaced the EU’s original Medical Device Directive (93/42/EEC MDD) and the EU’s Directive on active implantable medical devices (90/385/EEC AIMDD).

2. WHEN WAS THE MDR IMPLEMENTED?

The MDR came into force on 25 May 2017 and became applicable on 26 May 2021.

3. WHEN DID THE MDR TAKE EFFECT

The MDR was amended in April 2020 to extend the Date of Application to 26 May 2021. As of that date, new medical devices placed in the European market must meet the requirements of the MDR. Legacy device holding a certificate issued by an EU Notified Body under either the MDD or the AIMDD, may continue to be placed on the market until 26 May 2024, provided that the device manufacturer has fulfilled specific prerequisite requirements as detailed in the MDR Article 120.

4. HOW DO THE REQUIREMENTS IN THE MDR DIFFER FROM THOSE IN THE MDD/AIMDD?

Notable changes include:

• Product scope expansion—The definition of medical devices and active implantable medical devices has been significantly expanded to include devices that were note previously covered under the MDD and AIMDD. Specific examples of newly covered medical devices include those that do not have a medical intended purpose, as well as devices designed for the purpose of “prediction and prognosis” of a disease or other health condition.
• Reclassification of devices according to risk, contact duration and invasiveness–Annex VIII of the MDR details the requirements governing the classification of medical devices. In several instances, the MDR classification requirements are more rigorous than those in the MDD or AIMDD, resulting in the assignment of a higher risk class for some devices and the need to meet more stringent requirements than in the past.
• More rigorous clinical evidence for class III and implantable medical devices—Device manufacturers are now required to conduct clinical investigations to support claims of both safety and performance in a medical device in cases where sufficient clinical evidence is not available. Manufacturers are also required to collect and retain post-market clinical data as part of the ongoing assessment of potential safety risks.
• Systematic clinical evaluation of Class IIa and Class IIb medical devices—Manufacturers should carefully consider the MDR’s strict requirements on the use of evidence of equivalence in determining whether or not a clinical investigation is required.
• More stringent documentation—Annexes 2 and 3 of the MDR detail the technical documentation requirements applicable to all medical devices, including device description and specification, design and manufacturing information, general safety and performance requirements, risk management assessment, and product verification and validation. Of note is the MDR’s requirement that documentation be prepared in a clear, organized, and readably searchable manner to facilitate review by competent authorities.
• Identification of “person responsible for regulatory compliance”—Device manufacturers are now required to identify at least one person within their organisation who is at least be responsible for all aspects which are mentioned in MDR Article 15. The organisation must document the specific qualifications of this individual relative to the required tasks. Special relief for some of these provisions may be applicable to small enterprises and start-up entities.
• Implementation of unique device identification for better traceability and recall—The MDR mandates the use of unique device identification (UDI) mechanisms with medical devices. This requirement is intended to support the ability of manufacturers and Authorities to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk. In addition, the European Databank on Medical Devices (Eudamed) has been expanded to provide more efficient access to information on approved medical devices.
• More rigorous surveillance by Notified Bodies to reduce risks from unsafe devices—The MDR mandates increased post-market surveillance authority by the Notified Body. Unannounced audits, along with product sample checks and product testing will strengthen the EU’s enforcement regime and help to reduce risks from unsafe devices. Annual safety and performance reporting by device manufacturers is also required in many cases.
• No devices are exempt — After 26 May 2024, manufacturers of any medical devices previously certified under either the MDD or the AIMDD must ensure that their devices have been recertified as compliant with the MDR’s requirements in order to continue to legally market those devices in the EU.

5. WHAT ARE THE IMPLICATIONS OF THE MDR FOR MEDICAL DEVICE MANUFACTURERS?

The complexity in developing new and advance medical devices, combined with the rigorous requirements embodied in the EU’s MDR, are like to make the regulatory approval process challenging for many device manufacturers. Even manufacturers of medical devices that were previously approved under the MDD or the AIMDD are not exempt from the MDRs requirements, and legacy devices still being sold on the market must be recertified in accordance with the MDR’s provisions. 

Further, with the exception of Class I devices, an EU Notified Body must be involved in the approval and certification of all medical devices that fall within the scope of the MDR. Given the expanded scope of medical devices that require Notified Body review and approval, delays in the review and approval process should be anticipated. Device manufacturers are advised to consult with a Notified Body early in the product development process to plan the steps necessary to achieve timely and efficient MDR review and certification. Advanced preparation and early action are key.

6. WHAT CONSTITUTES A “SIGNIFICANT CHANGE” UNDER MDR TRANSITIONAL PROVISIONS, ARTICLE 120?

The Medical Device Coordination Group (MDCG) has published MDCG 2020-3, “Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD.” In its review of medical devices, TÜV SÜD will apply those criteria signifying “significant change in design or a significant change in the intended purpose” as detailed in the MDCG guidance.

7. BY WHAT DATE MUST THE NUMBER OF THE NOTIFIED BODY APPEAR ON CLASS I REUSABLE DEVICES?

Devices categorized under the MDD as a Class I reusable surgical instrument (Class Ir) that are subject to the provisions of the MDR 2^nd Corrigendum may continue to be placed on the market until 25 May 2024. In instances where there is no significant change to a given device, it must be labelled by 26 May 2024, as detailed in Article 120 of the MDR. Until the Date of Application, significant changes to a device’s design or intended use may be initiated and/or implemented under the MDD.

8. DO I NEED TO RECALL CLASS I REUSABLE DEVICES TO RE-LABEL THEM?

No, there is no requirement to recall Class I reusable devices which are placed on the market under the MDD before the Date of Application of the MDR. In general, devices that have been lawfully placed on the market under the MDD or the AIMDD before the MDR Date of Application can be made available and put into service until 25 May 2025.

9. WHERE CAN I GET MORE INFORMATION ABOUT MDR?

Download our guide on the expected changes of the MDR here. You can also follow the TÜV SÜD LinkedIn showcase page for Healthcare & Medical Devices for the latest information.

10. HOW DO I PREPARE FOR THE MDR?

It is highly advisable to stay informed about the requirements and deadlines of the MDR. A guide on the key changes of the MDR is available here. Additionally, it is important to perform an assessment of how your current product portfolio may be impacted by the regulations.

11. WHAT IS THE MDR IMPACT ON CERTIFICATION COST?

The MDR application and the auditing and designation processes require an extensive effort on the part of Notified Bodies, creating various unexpected costs that are reflected in the pricing for relevant services. Moreover, Notified Bodies have been required to restructure their organisations and increase resources to provide relevant services, thus increasing overall costs. Finally, the MDR requires increased regulatory oversight which involves additional and regular assessment, resulting in higher total certification costs over a 5-year period.

Please refer to TÜV SÜD Product Service GmbH Conformity Assessment Procedure page for the latest MDR certification cost.

12. How to request TÜV SÜD MDR SERVICES?

Since receiving designation and notification as a MDR Notified Body, TÜV SÜD has received a large number of requests for MDR certification. We take our responsibility as a designated Notified Body seriously and make every possible effort to support a smooth implementation of the regulation and avoid any negative impact on the European healthcare system. It is critical that a continued supply of safe and effective medical devices is available for patients.

Due to the extensive interest in our services, TÜV SÜD has introduced an online service registration to process MDR certification requests in an efficient and timely manner. If your company would like to work with TÜV SÜD to have your medical device certified in accordance with the requirements of the MDD, or would like to request further MDR services from TÜV SÜD, please register your interest at our online portal at www.tuvsud.com/mdrenquiry.