As part of Qualtech’s webinar series for the year 2023, Qualtech has held its first online event of this year on February 7th with the designated topic “EU MDR Updates”. For the purpose of this event, Qualtech had invited Mr. Arkan Zwick of Austrian Manufacturer Croma-Pharma GmbH to share his expertise of the European regulations with our audience. Serving in the role of the Regulatory Affairs Corporate Director, Mr. Zwick has shared many useful hints and provided thorough advice based on his own experience pertaining to how to obtain MDR certification in the smoothest way possible.
Therefore, below we will share a brief summary of the conditions to be utilized when intending to attain approval under the MDR, while also outlining the much talked about European Commission’s proposal to extend the MDR transition period as well as the validity of existing MDD certifications.
1. The European Commission’s (EC) Proposal – Extended Transition Period and Validity of MDD Certifications:
The European Commission, having noticed the vast number of MDD certifications expiring and the comparatively low number of MDR approvals issued, has published a proposal on January 6, 2023 to address this gap. Thus, the proposal is intended to aid in a) avoiding any interruptions of the supply of safe and effective products for patients in the European market, as well as b) providing additional time to manufacturers to comply with the MDR and obtain MDR certification. Therefore, the new proposal would allow an extension of the end of the transition period, along with an extension of the validity of existing MDD certificates.
Graph 1: Overview of the Number of MDR Applications Submitted and MDR Certifications Obtained as of October 2022. (This graph is property of the European Commission - Source)
The new transition that is proposed according to article 120 (3b) and (3c) stipulates that Class III devices and Class IIb implantable devices (exceptions are certain devices that are considered “well-established technologies”) shall be eligible for an extended end of the MDR transition period until 31 December 2027.
On the other hand, an extended MDR end of transition period until December 31 2028 shall apply for the following devices:
● Class IIb implantable devices, which are considered ‘well-established technologies’ (such as staples, or dental filling, etc.) and class IIb non-implantable devices;
● Class IIa devices;
● Class I devices (sterile and/or with measuring function), or which are reusable surgical instruments;
● Up-classified devices that require notified body involvement in the conformity assessment.
2. Required Conditions to be Eligible for the Extended End of Transition Periods:
However, it is crucial to notice that these extensions are not applied to every manufacturer automatically. Instead, certain conditions must be met by industry in order to benefit from these extended transition periods. The respective conditions have been outlined in Article 120(3d) MDR and entail the following:
● A continuous compliance with Directive 90/385/EEC or Directive 93/42/EEC is required.
● There shall be no significant changes in the design and intended purpose of the MDD product.
● There shall be no unacceptable risk to health or safety. That is, post-market data and the updated clinical evaluation report shall show that the benefit-risk ratio is still positive and that no significant risks are related to the product.
● The manufacturer’s quality management system shall be in place in accordance with the MDR by 26 May 2024 at the very latest.
● A formal application for MDR conformity assessment should have been made by 26 May 2024 and a contract between the manufacturer and the selected notified body shall be in place by 26 September 2024.
Thus, if these conditions are not met, the manufacturer is not able to benefit from the extended end of the transition periods proposed by the European Commission.
Furthermore, there are also specific conditions for certifications that have already expired. In such cases, the following conditions shall be met:
● The manufacturer shall have a contract for MDR certification signed with a notified body before the certificate’s expiry, or
● A National Competent Authority (NCA) shall have granted an Article 59 MDR derogation or 97 MDR application, respectively.
3. Current Status of Applicability of the European Commission’s Proposal:
It is important to keep in mind that as of now, the European Commission’s proposal is; in fact, just a legal proposal and does not represent a law just yet. However, it is expected to become a law shortly, in case all key entities (Council of the European Union, and the European Parliament) are accepting the proposal in the required legislative procedure. Once this is done, one may reasonably expect that the proposal will come into force before summer 2023.
- European Commission’s (EC) Proposal - REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
- Notified Bodies Survey on Certifications and Applications (MDR/IVDR) – Issued by the European Commission