EU MDR: Medical Device Regulation

Be confident of medical device market approval in the European Union

Be confident of medical device market approval in the European Union

medical device regulation overview

Medical device manufacturers will soon be confronted with major changes in the EU's decades-old regulatory framework, which governs market access to the European Union (EU). The MDR will replace the EU's current Medical Device Directive (93/42/EEC) and the EU's Active Implantable Medical Devices Directive (90/385/EEC).

The Medical Device Regulation was officially published on May 5, 2017 and came into force on May 25, 2017. Currently approved medical device manufacturers had an initially three-year transition time to May 26, 2020 which was changed to May 26, 2021 to meet regulatory requirements. For some manufacturers, the new EU MDR provides additional time after the date of application, allowing them to place new products for a maximum of 4 more years on the market. More requirements will apply for this extended transition period. Click here to access the published MDR on the Official Journal of the European Union. The corrigenda for the MDR and IVDR have also been made public in this official journal.

NBOG best practice on designation and notification of conformity assessment bodies

Guide on the expected changes

our medical device certification services

EU MDR: Medical Device Regulation in the European UnionThe new EU MDR imposes strict demands on medical device manufacturers and the Notified Bodies whom they must involve in the approval process of medical devices other than self-declaration class I devices.

TÜV SÜD Product Service is among the world's first certification bodies to receive designation as a Notified Body for the new Medical Device Regulation by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG).

With more than 750 medical device professionals in more than 30 locations worldwide, we are the largest EU Notified Body globally authorized to provide certification services under the new regulation.

KEY CHANGES TO THE EU MEDICAL DEVICE directives

The EU MDR differs in several important ways from the EU’s current directives for medical devices and active implantable medical devices. The most significant changes in the regulation include:

  • Product Scope Expansion - The definition of medical devices and active implantable medical devices covered under the EU MDR will be significantly expanded to include devices that have not a medical intended purpose, such as colored contact lenses and cosmetic implant devices and materials. Also included in the scope of the regulation are devices designed for the purpose of “prediction and prognosis” of a disease or other health condition.
  • Identification of "Qualified Person" - Device manufacturers will be required to identify at least one person within their organisation who is ultimately responsible for all aspects of compliance with the requirements of the new regulation. The organisation must document the specific qualifications of this individual relative to the required tasks. Special relief may apply to so-called micro and small enterprises.
  • Implementation of Unique Device Identification - The EU MDR mandates the use of unique device identification (UDI) mechanisms. This requirement is expected to increase 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) is expected to be expanded to provide more efficient access to information on approved medical devices.
  • Rigorous Post-Market Oversight - The EU MDR request 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 will also be required in many cases.
  • Specifications - The EU MDR plans to allow the EU Commission or expert panels to be defined to publish Common Specifications which shall then be taken into account by manufacturers as well as Notified Bodies. These Common Specifications shall exist in parallel to the Harmonized Standards and the State of the Art.
  • Reclassification of Devices According to Risk, Contact Duration and Invasiveness - The EU MDR will require device manufacturers to review the updated classification rules and update their technical documentation accordingly by considering the fact that class III and implantable devices will have higher clinical requirements and a regular scrutiny process.
  • More Rigorous Clinical Evidence for Class III and Implantable Medical Devices - Manufacturers will need to conduct clinical investigations in case they do not have sufficient clinical evidence to support the claims done on both safety and performance of a dedicated device. Device manufacturers will also be 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 - Manufacturer will need to re-prepare their clinical evaluation by considering the new wording of the regulation on when an equivalence approach and under which circumstances it is possible to justify not conducting a clinical investigation.
  • No "Grandfathering" Provisions - Under the EU MDR, all currently approved devices must be recertified in accordance with the new requirements. Exemptions are under negotiation right now.

Conformity assessment procedures

The complex development process for most types of medical devices, combined with the need to address new regulatory requirements and obtain Notified Body approval, is likely to make the transition a complicated and time consuming process for most device manufacturers. Further, currently approved devices are not exempt from the requirements of the new regulation and will need to be re-evaluated and re-approved.

As manufacturers need to apply for an applicable conformity assessment procedure based on their product classification, a step by step information guide on each of the procedures is provided here

Speak to your notified body today

Since a large number of medical devices will now require Notified Body review and approval, delays in the review and approval process by Notified Body should be expected. Therefore, it is recommended that manufacturers of currently approved devices consult with their respective Notified Body to evaluate potential compliance issues and to develop a plan to address them promptly. Advanced preparation and early action will be key to ensuring a smooth transition to the new requirements. 

FAQ


  • What is the Medical Device Regulation (MDR)?

    The Medical Device Regulation (MDR) will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).

  • When was the MDR implemented?
    The MDR came into force on May 25, 2017.
  • When do medical device manufacturers need to comply with the MDR?

    The amendment to the MDR was published in April 2020, amending the MDR Date of Application to May 26, 2021. Since May 26, 2021, new devices must meet the requirements of the MDR in order to be placed on the European market. Devices holding a certificate from a European Notified Body under either the Medical Device Directive (93/42/EEC) or the Active Implantable Medical Devices Directive (90/385/EEC) have an additional grace period, and they may continue to be placed on the market until May 26, 2024 if the manufacturer fulfills the specific prerequisite requirements of the MDR.


  • What are the key changes in the new MDR?

    Some of the key changes include:

    • Product scope expansion. The definition of medical devices and active implantable medical devices will be significantly expanded to include devices that do not have a medical intended purpose.
    • Reclassification of devices according to risk, contact duration and invasiveness. The MDR will require device manufacturers to review the updated classification rules and update their technical documentation accordingly by considering the fact that class III and implantable devices will have higher clinical requirements and a regular scrutiny process.
    • More rigorous clinical evidence for class III and implantable medical devices. Manufacturers will need to conduct clinical investigations in case they do not have sufficient clinical data to support the claims done on both safety and performance of a dedicated device.
    • Systematic clinical evaluation of Class IIa and Class IIb medical devices. Manufacturer will need to re-prepare their clinical evaluation by considering the new wording of the regulation on when an equivalence approach and under which circumstances it is possible to justify not conducting a clinical investigation. 
    • More stringent documentation.
    • Identification of ‘person responsible for regulatory compliance’
    • Implementation of unique device identification for better traceability and recall
    • More rigorous surveillance by Notified Bodies to reduce risks from unsafe devices
    • Greater Scrutiny of Notified Bodies
    • No “grandfathering” provisions. All currently certified medical devices and active implantable medical devices must be recertified in accordance with the new requirements.
  • What are the implications of the new MDR for medical device manufacturers?

    The complex development process for medical devices, combined with the changes, make the transition a complicated and time-consuming process for most device manufacturers.

    Because of these complexities, medical device manufacturers are well-advised to stay current on the progress of the MDR. Since a large number of medical devices are expected to require Notified Body review and delays in the review and certification process by the Notified Body should be expected. Manufacturers of currently certified devices are therefore advised to consult with their respective Notified Body to evaluate potential compliance issues and to develop a plan to address them promptly. Advanced preparation and early action will be the key to ensuring a smooth transition to the new requirements.

  • What is 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. TÜV SÜD will be following the definition of significant changes outlined in the MDCG guidance.

  • From when does the number of the Notified Body need to appear on Class I reusable devices?

    If the 2nd Corrigendum to Regulation (EU) 2017/745 applies to the MDD Declaration of Conformity of a class Ir reusable surgical instrument, a grace period for continued placement into the market until May 25, 2024 applies. If following Article 120 of the MDR, there is no significant change to the device, the class Ir device must be labeled by May 26, 2024 at the latest. Significant changes such as device design or intended use changes (impacting reprocessing) may be initiated/implemented under MDD until the MDR Date of Application.

  • Do I need to recall Class I reusable devices to relabel them?

    No, you do not need 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/AIMDD before the MDR Date of Application, can be made available and put into service until May 25, 2025.


  • How long will TÜV SÜD accept submissions for MDD certificate renewals?

    TÜV SÜD stopped accepting limited MDD/AIMDD applications and submissions the end of October 2020. This includes renewals and change notifications. Our general recommendation would be for clients to apply for MDR certification despite the new MDR Date of Application (May 26, 2021) as the additional grace period until May 26, 2024 remains unaffected.


  • Where can I get more information about the 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.

  • How do I prepare for the MDR?

    In preparing for the MDR, it is important to inform yourself about the requirements and deadlines of the new 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 new regulations.

  • What is the MDR impact on certification cost?

    The MDR application, auditing and designation process required a large amount of effort from Notified Bodies, creating various unexpected costs that will be reflected in the future pricing for relevant services. Moreover, for the new regulation, Notified Bodies are required to restructure their organization and increase resources to provide relevant services thus increasing production costs. MDR demands higher regulatory oversight which requires additional and regular assessment, resulting in higher total certification costs within a period of 5 years.

    The following standard fees apply for the conformity assessment activities rendered out from Germany:

    Audit and QM System Assessment Services

    Hourly rate

    Audit

    290€

     Assessment of Change Notifications and Extensions for Quality systems, MDR

    290€ 

    Technical Documentation Assessment Service

     

    Technical Documentation Assessment Offsite 

     390€

  • How is the MDD-AIMDD/MDR transition affecting TÜV SÜD's review cycles of current projects?

    Earlier preparation for MDR/IVDR designation and ongoing implementation efforts for MDR certification services tie up resources which are involved in projects under the current legislative framework. This means that current assessment and certification decision timelines cannot be ensured and must be in most of the cases extended. Please consider this when communicating with your client manager and plan your project following the extended timelines.

  • When can TÜV SÜD provide MDR services?

    TÜV SÜD is currently in a transition phase where we are shifting and preparing our systems and resources to provide services under the new legislative framework. We have had and continue to clarify open questions and implement newly published information about the MDR into our processes.

    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 very 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 your request systematically in an appropriate time. In the event that your company is interested in the certification of your devices according to the Medical Device Regulation with TÜV SÜD, or would like to request further MDR services from TÜV SÜD, please contact us.

  • As a European manufacturer from a non-member country, can I apply for MDR certification with TÜV SÜD? Is there anything I would need to take note of?

    Under the MDD/AIMDD, the European Union had agreements in place with other countries like Switzerland and Turkey which provided regulations for different aspects, e.g. the EU authorized representative. Countries like Norway, Iceland and Lichtenstein belong to the EFTA countries and additional agreements are not necessary.

    However, no* agreements are finalized between the European Union and Switzerland respectively with Turkey  in regard to the MDR yet. Therefore, if a manufacturer from one of those non-member countries applies for MDR certification with a notified body, they are required to have the following installed till a mutual recognition is valid covering the new legislation:

    1. Authorized representative established within one of the EU 27 Member States
    2. PRRC in the EU 27 Member States which permanently available for their AR (see guidance MDCG 2019-7)
    3. Importer established within one of the EU 27 Member States

    * This information is accurate as of publication on January 14, 2020. Please always check the latest status regarding agreements between the EU and other non-member countries. 

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