MDR Extension Accepted until December 31, 2027/2028

Yesterday, the European Parliament, with 537 votes in favor and 3 against, accepted the proposal to postpone the MDR.

For class IIb implantable and class III devices, the applicability of the MDR is postponed to December 31, 2027. For class I devices requiring a notified body, class IIa and IIb devices, the extension is until December 31, 2028.

Additionally, the May 2025 deadline has been removed, preventing safe medical devices already on the market from having to be eliminated.

The Impact of the MDR Postponement

Valid MDD certificates as of May 26, 2021, and not revoked, will be valid until December 31, 2027/2028 (depending on the class). The extension is directly applicable: notified bodies are not required to modify the date on individual certificates.

A manufacturer with a valid MDD certificate can continue to place their devices on the market.

However, MDD certificates that have already expired at the time the extension comes into force can benefit from the postponement, provided that, at the time of expiration, the manufacturer had signed a contract with a notified body for the certification of the device according to MDR.

Class I medical devices that change class or for which notified body intervention is required, for which a declaration of conformity was drawn up before May 26, 2021, can be placed on the market until December 31, 2028.

Conditions for Benefiting from the Extension

The above-mentioned devices can continue to be placed on the market until December 31, 2027/2028 (depending on the class), provided that:

• These devices continue to comply with Directive 93/42/EEC;
• There are no significant changes in design and intended purpose;
• The devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of public health protection;
• By May 26, 2024, at the latest, the manufacturer has implemented a quality management system;
• By May 26, 2024, at the latest, the manufacturer has submitted a formal application for conformity assessment under MDR, and no later than September 26, 2024, the notified body and the manufacturer have signed a written agreement.

2027 or 2028?

December 31, 2027, for class III devices and class IIb implantable devices, except suture materials, staples, dental filling materials, orthodontic appliances, dental crowns, screws, wedges, plates and prostheses, wires, pins, clips and connectors.

December 31, 2028, for class IIb devices other than those mentioned above, for class IIa devices, and for class I devices that are sterile, have a measuring function, change class, or for which notified body intervention is required.

Redefining the Approach

The important aspect, at this moment, is to redefine the established approach.
It is not advisable to delay initiating relationships with a notified body. Despite this, the possibility of continuing to sell one’s medical devices is certainly good news.

We remain available to delve into the details of each individual case and define the applicability of the MDR postponement to 2027/2028.