MDR Update: EPSCO Proposes Transition Improvements and EU Commission Issues MDCG 2022-18
At the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) meeting on 9 December 2022, EU Member States unanimously agreed that actions should be taken to ensure that the supply of medical devices is maintained during the Medical Device Regulation (MDR) transition period. Specific issues regarding Notified Body capacity and ongoing expiration of the EU’s Medical Device Directive (MDD) certificates during transition were the main concerns.
In an effort to mitigate these concerns, the Medical Device Coordination Group (MDCG) issued a new guidance document on 9 December 2022 to allow extensions for devices which are shown to be safe. These are short-term measures to allow for the continued supply of devices, with the EU Commission providing additional measures on structural problems of the regulations via legislation (expected January 2023). These measures are expected to include the extension of the transition period for the MDR based on device risk, as well as the removal of the “sell off” provision deadline of May 2025. The recommendation is that lower-risk class devices will have until 2028, whereas higher-risk class devices will have until 2027, for adjusted transition periods.
It should be noted that the MDCG document is not concerned with this change; therefore, the output of the meeting is still only a recommendation for action until the proposed change has been confirmed by additional EU Commission legislation.
The EPSCO meeting confirmed that the EU Commission and Medical Device Taskforce will also work on further medium- and long-term solutions to the present issues with MDR implementation. Such solutions will help shape the regulatory environment to foster innovation and allow Notified Bodies to focus on key tasks such as patient safety and less bureaucracy. Additionally, a Pilot Project in Q1 2023 will offer scientific advice from expert panels, targeting orphan1 and breakthrough devices.
Lastly, the EU Commission will undertake a comprehensive evaluation of the regulatory framework by 2027, and if a negative impact on public health or patient safety/innovation is identified, then amendments to the regulations will be proposed.
Note 1: Orphan medical devices are devices intended for the treatment of a very rare life threatening or chronically debilitating condition.
Main Aspects of MDCG 2022-18
The main requirements of the derogation process described in MDCG 2022-18 are as follows:
(i) Only devices which can be shown to be safe can follow this process.
(ii) It applies to legacy devices only.
(iii) MDD/AIMD Certification must be valid when it expires (e.g. cannot be suspended).
(iv) No significant changes have occurred to the device as per MDR Article 120(3).
(v) The manufacturer must submit safety reports of the devices (Post-Market Surveillance [PMS] & vigilance data) for Competent Authority review. The reports are to be submitted to the Competent Authority where manufacturer or EU Rep is located. The Competent Authority will also review any data it may have on the device (e.g. old vigilance reports, Field Safety Notices [FSNs], Field Safety Corrective Actions [FSCAs], recalls).
(vi) The Competent Authority will send a letter to the manufacturer stating that they can still sell the device without a CE certificate. This letter can then be used by economic operators to show proof to other Competent Authorities that this process has been correctly followed.
(vii) The transitional requirements of Article 120 are still required (e.g. PMS/Post-Market Clinical Follow-Up [PMCF], registration, etc.).
(viii) Derogation will only be allowed if the manufacturer has made reasonable efforts to get MDR certification—application for conformity assessment under the MDR should have been accepted by a Notified Body and a written agreement signed by Notified Body and manufacturer. There are exceptions to this requirement for Small and Medium-Sized Enterprises (SMEs).
(ix) The letter from Competent Authority will define the time the manufacturer has to close non-compliance (i.e. achieve MDR certification)—the time can be extended only by agreement of the Competent Authority which issued the original letter.
The exceptions for SMEs are as follows:
I. The manufacturer is an SME (see EU Directive 2003/361/EC for definitions of SME2).
II. The MDD or AIMDD certificate of the SME has been issued by a Notified Body not (yet) designated under the MDR.
III. The SME can demonstrate that it has undertaken reasonable efforts to apply to a considerable number3 of relevant Notified Bodies and that their application has not been accepted due to limited Notified Body capacity.
- The category of micro, small and medium-sized enterprises (SMEs) is made up of enterprises which employ fewer than 250 persons and which have an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million.
- Within the SME category, a small enterprise is defined as an enterprise which employs fewer than 50 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 10 million.
- Within the SME category, a microenterprise is defined as an enterprise which employs fewer than 10 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 2 million.
Note 3: Considerable number has not been defined in the MDCG but it is recommended that at least 5 x Notified Bodies are contacted as a minimum.
This MDCG is a “stop-gap” measure likely applicable only to devices whose certificates have already expired or will expire prior to the new legislation published in January 2023 (i.e. reduce the necessity to place large quantities of devices on the EU Market before MDD/Active Implantable Medical Device [AIMD] certificate expires). The practicality of the process remains to be seen, given the limited capacity within Competent Authorities to take on the CE marking responsibility for devices within the scope of the MDCG. It is also possible that Competent Authorities may set a higher bar for allowing these devices to remain on the EU market compared to expectations from Notified Bodies. Therefore, it may not be a simple route for manufacturers to keep their devices on the EU market.
The conclusions of the EPSCO meeting and the publication of MDCG 2022-18 provide more flexibility for manufacturers under great pressure to achieve MDR certification by May 2024, particularly given the limited capacity of Notified Bodies. However, the extension of the deadlines for MDR certification should not be viewed a reason to slow down the MDR submission process. This is especially true given the experience to date where MDR certification for legacy devices can take at least 12 months or, in many cases, longer. For devices that are relying on further clinical data to be generated via PMCF, it does allow manufacturers to gather more data, ultimately increasing the chances of successful certification.
Finally, the MDCG guidance allows manufacturers to plan their transition from MDD to MDR compliance with greater preparation time and confidence that their devices should not encounter a loss of certification. This is due to the fact that devices can be made available through Article 97 derogation if they meet the above described safety and regulatory criteria.
How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the Competent Authorities and Notified Bodies. Our internal teams of medical device regulatory experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for manufacturers. In fact, many of our Associates have previously held positions within these organizations, which provides Clients the benefit of a clearer understanding on how to proactively plan for international requirements and expectations.
To learn about NAMSA’s full suite of Regulatory and Quality services and solutions, including MDR compliance planning, please visit: https://namsa.com/services/regulatory-and-quality-consulting/.
Or, if you are interested in meeting with one of our regulatory experts, please visit: https://namsa.com/namsa-expertise/subject-matter-experts/.
Kevin Butcher is an experienced Senior Manager with extensive knowledge of medical device regulatory requirements, including Product Technical Files and QMS 3rd Party auditing. Mr. Butcher possesses 18 years of Notified Body experience, latterly as Certification Manager for SGS United Kingdom. Kevin joined the medical device consulting team at NAMSA in January 2021 and currently serves as a Principal Regulatory Consultant.
Thomas has 14 years’ experience in the medical device industry within the fields of orthopaedic and dental products. Mr. Miramond has a rich and varied experience on the academic side with collaborative translational health research projects, as well as on the manufacturer side. Manufacturing roles include R&D Project Manager, Preclinical Department Head, Notified Body Expert Assessor for MDD/MDR devices, and Consultant for valorisation of research and innovation. Thomas has a deep scientific background in biomaterials (polymers, bioceramics and metals) and his core expertise lays within implantable devices incorporating In Vivo derivatives, medicinal substances and association with stem cells for Bone Tissue Engineering clinical approach. He focus at NAMSA includes complex submissions for implantable devices, which include: development of regulatory, preclinical and clinical strategies and MDR transition gap analysis; technical documentation compilations and regulatory due diligence.