New MDR Extension to 2027/2028 Accepted

The speech by Commissioner Stella Kyriakides at the EPSCO Council on December 9, 2022, aimed at promoting the postponement of MDR applicability, was clear and contextualized.

The new proposed dates: for class IIb and III devices, MDR applicability will be postponed to 2027; for class I devices with notified body and class IIa, the extension is planned for 2028.

Additionally, she proposes the removal of the May 2025 deadline, preventing safe medical devices already on the market from being eliminated, and requests that notified bodies reduce bureaucracy by focusing on the true objective of ensuring patient safety.

Finally, it is likely that the MDR postponement will be accompanied by a derogation of the validity of CE certificates in accordance with Directive 93/42/EEC.

The discussion of the proposal and – presumably – its approval, will take place in January 2023. Concurrently, a new MDCG is expected to be issued to guide manufacturers in case of new postponements.

The Possibility of Obtaining an Extension According to MDCG 2022-18

Following the speech during the EPSCO Council, the Medical Device Coordination Group published the MDCG 2022-18.

The guideline provides an unprecedented interpretation – but to be considered valid and applicable – of Article 97.

In essence, manufacturers whose MDD certificate has expired, but who have initiated an MDR certification process that is not yet completed, can request the competent authority for a derogation to continue marketing until the new certificate is issued.

The above appears very similar to an article already present in the Regulation, Article 59. The difference being that the latter required demonstrating that the device was vital for public health and without adequate substitutes on the market.

The duality is confirmed by the fact that the MDCG itself states that where this new interpretation of Article 97 applies, further derogations under Article 59 are no longer necessary.

In summary:

• Article 59 allowed manufacturers to request a derogation period, provided it was justified;
• In January 2023, the postponement of MDR applicability to 2027/2028 will be evaluated;
• In the meantime, the MDCG has published a guideline based on Article 97, whose application makes Article 59 superfluous and still allows for obtaining a derogation period.

You can rely on Sistemir for developing the declaration required by Article 97 and managing relations with the Ministry of Health to obtain the extension.

Especially during this period, it is essential to have adequate support. A potential future postponement of the MDR might not encompass all devices and manufacturers, but rather apply only to those who can demonstrate compliance with specific requirements set by the European Commission.

The Impact of the Postponement

The proposal comes after a cursory analysis of the causes (subject of MDCG 2022-11) and the attempt to solve the problem with 19 points that, in fact, did not bring any concrete changes (MDCG 2022-08).

Now, it’s impossible not to emphasize that these measures are coming late.

Manufacturers who have discontinued production lines and products due to increasing costs – in resources and economics – are at a disadvantage, companies that have focused investments on maintaining their devices at the expense of innovation are disadvantaged, manufacturers who have successfully hired and pursued deadlines are disadvantaged, their market strength will be lower than those who have remained observers, keeping costs diametrically lower.

The system is not working, and it was already announced in 2017, at the first publication of the Regulation, that it was destined to collapse.

We remain waiting for future developments and available for clarifications related to the current situation.