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New EU MDR Deadlines

What you need to know

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New EU MDR Deadlines
What you need to know

Medical devices save lives by providing innovative disease diagnosis, prevention, monitoring,
treatment, and alleviation solutions. In April 2017, the European Parliament and the Council
adopted Regulation (EU) 2017/745 and Regulation (EU) 2017/746 to reinforce the regulatory
framework for medical devices and in vitro diagnostic medical devices.

They strive to ensure patient and user health and a successful internal market for these
products. In light of issues with the previous regulatory framework, the Regulations establish a
more thorough conformity assessment system to ensure device quality, safety, and
performance on the EU market.

The Medical Devices Regulation has been applicable since 26 May 2021. It provides for a
transition period until 26 May 2024.

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. This paper
highlights the key elements.

What is the proposal?

The Commission have adopted a proposal to give more time to certify medical devices to
mitigate the risk of shortages. Under the Medical Devices Regulation, the proposal 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 on the market in conformity with current law to stay on
the market (no "sell-off" date).

None of the current safety and performance requirements in the MDR are changed by this
proposal. It only amends the transitional provisions to give manufacturers more time to
transition to the new regulation requirements.

What are the new dates and are you eligible?

For medical devices covered by a certificate or a declaration of conformity issued before 26
May 2021, the transition period to the new rules is extended:

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• Higher risk devices have until 31 December 2027.

• Medium and Lower risk devices have until 31 December 2028.

However, the extensions will be subject to certain conditions.

In order to benefit from the additional time, the device must be safe, and the manufacturer
must have already taken steps to transition to the EU MDR.

• Class III implantable custom-made devices have until 26 May 2026.

This means manufacturers have more time to obtain certification by a Notified Body.

However, in order to benefit from the time extension, the manufacturer must have submitted
an application for conformity assessment (to a notified body) for their Class III implantable
device(s) before 26 May 2024.

NOTE: The conformity assessment is a necessary step for a device to be placed on the EU
market. The conformity process is designed to ensure that the device meets the EU MDR safety
and performance requirements. It includes submission of the conformity route and classification
and a review of technical documentation (such as the CER) and any other required information.
All the information from the conformity assessment must be included in the device technical
documentation. The NB then decides whether to issue a certificate of conformity which is
required to sell on the EU market.

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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 that have already been placed on the
market should 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 proposal will now be negotiated by the European Parliament and the Council. It needs to
be adopted by the EU Parliament and the Council through an accelerated co-decision
procedure.

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
your transition and ensure you are MDR compliant. To learn more about our services and how
we can help. Get in touch!

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