New EU MDR Deadlines
What you need to know
The EU MDR has been applicable since 26 May 2021, and it provided a transition period until 26 May 2024. However, there are growing concerns over the overall capacity of conformity assessment (‘notified’) bodies and manufacturers not being sufficiently prepared to meet the strengthened requirements of the MDR transition period. As this impacts the availability of medical devices on the EU market, the EU Ministers of Health urged the Commission to urgently submit a Medical Device Regulation transition period extension request at the EPSCO Council on 9 December 2022, and a proposal was available by 6 January 2023. This paper highlights the key elements of that proposal.
What is the proposal?
The Commission has adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. Article 120 of the EU MDR extends the transition period from 26 May 2024 to adapt to the new rules. However, the new deadlines depend on the devices’ class. This will ensure continued access to medical devices for patients. It will also allow medical equipment in conformity with current law to remain on the market (no “sell-off” date).
This proposal does not change the current safety and performance requirements in the MDR. It only amends the transitional provisions to give manufacturers more time to transition to the new regulation requirements.
What are the new deadline dates for EU MDR and are you eligible?
Under the proposal, they extended the transition period deadline from 26 May 2024 to 31 December 2027 or 31 December 2028 (using Article 120-3). For medical devices covered by a certificate or declaration of conformity issued before 26 May 2021, the transition period to the new rules is extended as follows:
- Higher risk devices have until 31 December 2027.
- Medium and Lower risk devices have until 31 December 2028.
- Class III implantable custom-made devices have until 25 May 2026.
However, the extensions will be subject to certain conditions under Article 120.
- The devices must continue to comply with MDD or AIMDD, as applicable.
- The devices must not undergo “significant changes” in design and intended purpose (see MDCG 2022-6).
- The devices must not present an “unacceptable risk to health and safety.” The amending act clarifies that the concept of “unacceptable risk to health and safety” is set out in Article 94 and 95 of the MDR. In practice, this does not present manufacturers with a new requirement. According to the amending act, no systematic checks of devices’ safety are required to qualify for the extension under this limb. However, where a national competent authority finds that a device presents an “unacceptable risk,” the transitional period will cease to apply.
- By 26 May 2024, the manufacturer must have put in place a Quality Management System (QMS) in compliance with Article 10(9) of the EU MDR. No specific attestation, for example a self-declaration or verification of the appropriateness of the QMS by a Notified Body, will be needed to meet this requirement. According to the amending act, the submission of an application for conformity assessment to a Notified Body will be interpreted as an implicit confirmation that a QMS is in place and compliant with EU MDR.
- By 26 May 2024, the manufacturer must have lodged a formal application for an EU MDR conformity assessment for the legacy device, and by 26 September 2024, the parties must have signed a written agreement (contract) for such conformity assessment. The aim is to ensure that only devices intended to transition to the MDR will benefit from the extended transition period. In practice, the aim is to avoid unnecessary applications for certification of devices that are intended to be phased out or replaced by new models.
Is your device certificate valid?
The proposal extends the validity of certificates issued up until 26 May 2021. Which is when the EU MDR took effect.
What about the device ‘sell-off’ date?
The Commission also proposes to remove the “sell-off” date currently established in the EU MDR and EU IVDR. The “sell-off” date is when the devices already on the market need to be withdrawn. Removing this “sell-off” date will ensure that safe and essential medical devices already on the market will remain available to healthcare systems and patients in need.
What are the next steps?
The European Parliament and Council will now negotiate the proposal. The EU Parliament and the Council must approve it through a process called “accelerated co-decision.”
CLIN-r+ Recommendations
To assist in your MDR transition, collaborate with a clinical and assurance consultancy. This will make it much easier to achieve a solid MDR transition from gap assessments to strategy to technical documentation. They can also help create all the materials your project team needs. Manufacturers frequently underestimate the resource requirements of a MDR transition. A consultancy can contribute desperately needed resources and knowledge to lighten the load.
Clin-r+ provides expert assistance and has a wealth of experience to call upon. We can assist with your transition and ensure you are MDR compliant. To learn more about our services and how we can help. Get in touch!
Supporting an MDD to MDR transition
EU MDR Readiness Checklist
