mdr faqs

FAQs - Medical Device Regulation (MDR)

Cách thức tiếp cận thị trường EU cho Thiết bị y tế

Cách thức tiếp cận thị trường EU cho Thiết bị y tế

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 EU’s MDR requirements were originally scheduled to take full effect in May 2020, providing manufacturers with a three-year transition period to bring existing medical devices into compliance with the MDR’s requirements. Due to the challenges presented by the global COVID-19 pandemic, 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.

However, the implementation of certain MDR provisions will be postponed until as late as December 2028 for medical devices that were previously approved under the Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or covered by Declaration of Conformity (DoC) issued before 26 May 2021. The extended transition periods are:

  • 26 May 2026 - for class III custom-made implantable devices
  • 31 December 2027 - for higher-risk products (class III devices and class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors)
  • 31 December 2028 - for medium and lower risk products (other class IIb devices, class IIa devices, and class ls, lm, lr)

It’s important to note that the extension of transition period to the new rules is subjected to certain conditions. More time will only be granted for products that are safe and for which manufacturers have already taken steps regarding the transition to MDR:

  • This means that the application has to be submitted latest by 26 May 2024 and the contractual agreement with TÜV SÜD has to be concluded latest by 26 September 2024.

Please note, that the extension of timelines does not apply to Class I devices that do not require a MDR certificate from a notified body. New devices and devices without a former MDD/AIMDD certificate are also required to meet the MDR requirements from 26 May 2021.

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 not 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 II and III 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 ultimately responsible for all aspects of compliance with the requirements of the MDR. 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 - Depending on the product classification, manufacturers of any medical devices previously certified under either the MDD or the AIMDD, as well as devices for which a DoC was drawn up prior May 2021 and under MDR need the involvement of a NB, have up to December 2028 to ensure that their devices have been newly certified 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 likely 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 ” 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 did not require the involvement of a Notified Body. With the MDR an involvement is necessary for those devices (Class Ir). Further these are subject to the provisions of the amendment REGULATION (EU) 2023/607 and may continue to be placed on the market until 31 December 2028. Afterwards, the device needs a certification by a MDR Notified Body, and the respective labelling with the number of the NB.

The amendment REGULATION (EU) 2023/607 applies also to devices that fall under Class I sterile (Is) and Class I with a measuring function (Im). The new timelines do not apply to Class I devices that do not have a current MDD certificate and do not require a MDR certificate. 

However, extension of transition period to the new rules is subjected to certain conditions. More time will only be granted for products that are safe and for which manufacturers have already taken steps regarding the transition to MDR:

  • This means that the application has to be submitted latest by 26 May 2024 and the contractual agreement with TÜV SÜD has to be concluded latest by 26 September 2024.  

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 31 December 2028, subjected to certain conditions mentioned in section 7.

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 the following pages for the latest MDR certification cost:

12. HOW TO REQUEST FOR 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.

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