EU Medical Device Regulation (MDR)
Our experts provide EU MDR guidance at each step of the way so your company transitions efficiently and successfully.
MDR Transition Timelines
• 26 May 2024: The manufacturer needs to comply with the quality management system (QMS) requirements of the MDR.
• 26 May 2024: The application for conformity assessment of the QMS must be initiated with the NB and should include the
documentation of the manufacturer’s QMS.
• 26 May 2024: All devices, except those covered by the extended transition period, must comply with the MDR.
• 26 May 2026: Class III implantable custom-made devices must comply with the MDR.
Which evidence does the manufacturer have to provide for having put in place a QMS in accordance with the MDR?
Pursuant to Article 120(3c), point (d), MDR the manufacturer must put in place a QMS in accordance with Article 10(9) MDR no later than 26 May 2024. Manufacturers must draw up the documentation on its QMS, which needs to be part of the application for conformity assessment. Compliance with QMS-related requirements concerning postmarket surveillance, market surveillance, vigilance and registration are part of the appropriate surveillance pursuant to Article 120(3e) MDR, while the assessment of the compliance with the MDR of the entire QMS will be done by the notified body as part of its conformity assessment activities.
Which devices can benefit from the extended transitional period?
Only “legacy devices” can benefit from the extended transitional period. In line with MDCG 2021-252 “legacy devices” should be understood as devices, which, in accordance with the MDR’s transitional provisions, are placed on the market after the MDR’s date of application (i.e. 26 May 2021) if certain conditions are fulfilled.
Those devices can be:
:• Devices which are class I devices under Directive 93/42/EEC (MDD), for which an EC declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body.
• Devices covered by a valid EC certificate issued in accordance with Directive 90/385/EEC (AIMDD) or the MDD prior to 26 May 2021.
The extension of the transitional period beyond 26 May 2024 only applies if the conditions laid down in Article 120(3c) MDR are fulfilled. In case of devices for which the relevant certificate has expired before 20 March 2023, also the conditions laid in the second subparagraph of Article 120(2), points (a) or (b), MDR need to be fulfilled.
What are the necessary elements of a formal application for conformity assessment lodged by the manufacturer?
Pursuant to Article 120(3c), point (e), MDR the manufacturer or the authorised representative must lodge a formal application for conformity assessment in accordance with Section 4.3, first subparagraph, of Annex VII MDR no later than 26 May 2024. Manufacturer and notified body must sign a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII MDR no later than 26 September 2024 to benefit from the extended transitional period.
Article 120(3c), point (e), MDR does not refer to a review of applications in accordance with Section 4.3, third subparagraph, of Annex VII MDR. That means that a full review of the application by the notified body is not required before the signature of the written agreement. The application should, in principle, include the elements listed in the relevant conformity assessment as referred to in Annexes IX to XI to the MDR. However, it needs to be taken into account that a full review of the application prior to the conclusion of the written agreement is not required and that the time span between the deadline for the application (May 2024) and the actual conformity assessment activities to be performed by manufacturers and notified bodies can be very long (until 2028 at the latest).
Therefore, the documentation that the notified body does not need for the conclusion of the written agreement with the manufacturer and that is likely to be updated by the manufacturer before the actual conformity assessment does not need to be submitted with the application. That means that the application does not need to include, for example, the technical documentation for each device covered by the application and which is subject to technical documentation review.
However, the application must clearly identify the manufacturer and the devices covered by the application for example by including the list of devices intended to be transferred to the MDR and, where applicable, the device(s) intended to substitute a ‘legacy device’. The information submitted with the application needs to allow the notified body to verify the qualification of the products as devices, their respective classification and the chosen conformity assessment procedure.
When lodging the application, the manufacturer should provide a timeline for possible submission of the individual technical documentation and any other relevant information. Notified body and manufacturer should agree on a plan for submission of the relevant technical documentation or other information needed for the conformity assessment activities in due time.
How we can help:
BioVision’s consultants are ready to fully support your CE Marking transition from the Medical Devices Directive (MDD) to the Medical Devices Regulation (MDR).
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EU MDR 2017/745 Gap Assessment and CE Transition Strategy for Medical Device Manufacturers.
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Helping with strategy planning and finance consulting.
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On-Site Medical Devices Regulation (EU MDR) Training for Manufacturers.
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Health Canada submissions.
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MEDDEV 2.7.1 rev 4 and Clinical Evaluation Reports (CER) for Medical Devices.
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EU MDR compliance consulting for devices that do not have a medical intended purpose (Annex XVI).
Key changes MDR versus MDD:
Product scope expansion
The definition of medical devices and active implantable medical devices covered under the MDR will be significantly expanded to include devices that do not have a medical intended purpose (Annex XVI).
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.
Clinical evidence for class III and implantable medical devices
Manufacturers will need to conduct clinical investigations if they do not have sufficient clinical evidence to support the claims for both safety and performance aspects of a dedicated device.
Clinical evaluation of Class IIa and Class IIb medical devices
Manufacturers will need to revise their clinical evaluation by considering the new wording of the regulation for an equivalence approach and under which circumstances it is possible to justify not to conduct a clinical investigation.
Post-market Surveillance
The MDR request increased post-market surveillance authority by the Notified Body.
Identification of the " Person Responsible for Regulatory Compliance (PRRC)"
Device manufacturers will be required to establish the role of the Person Responsible for Regulatory Compliance (PRRC) within their organization who is ultimately responsible for
all aspects of compliance with the requirements of the new regulation.
Implementation of unique device identification
The 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.