MDR /IVDR amendment

Today (16th of February), The European Parliament voted (and approved) the amendment of the MDR/IVDR of the EU Commission and Council of European Union.

The Medical Devices Regulation (EU) 2017/745 (MDR)?entered into force in May 2017, replacing the old Medical Device Directive (MDD; 93/42/EEC medical devices).

However, it has been obvious since 2019 that there are not enough Notified Bodies to carry out the certification, considering the number of existing medical devices in relation to the number of Notified Bodies. Notified bodies are organizations?designated by EU member states to assess whether regulated products meet technical requirements before they can be sold in Europe.

The number of notified bodies dropped significantly because they had to comply with the stricter requirements under the MDR

In the EU, there are 33 Notified Bodies designated for the MDR and only seven Notified Bodies established for the IVDR. This illustrates the need for Notified Bodies.

The lack of certified Notified bodies was a bottleneck for the certification of new medical devices (and re-certification of existing devices that were originally certified under the old legislation). This meant that those medical devices, whose manufacturers are unable to find a Notified Body, will have to be withdrawn from the market at the end of the transitional period.

In December 2022 the European Union Health Commissioner Stella Kyriakides?proposed?delaying MDR enforcement by three to four years to prevent product shortages and buy time to implement “additional measures to address the structural problems” with the regulation.

New deadlines :

Class III and Class IIb devices : 31st December 2027

Class IIa & Class I devices : 31st December 2028

Class III Implantable custom-made devices : 26th May 2026

Extends Validity of Certificates Issued up to 26th May 2021

Removes the ‘sell-off’ date (for MDR &IVDR)