Dezember 21, 2022
Regulatory

EU Commissioner Proposes Extention Of Transition Period Of MDR

The European Commissioner for Health and Food Safety, Stella Kyriakides, has suggested measures to extend the transition rules of Medical Device Regulation (EU) 2017/745 (MDR) at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council meeting on Friday, 9 December 2022.

In her opening speech at the ESPCO meeting, the Commissioner said:

"The transition to the new rules has been slower than we anticipated. The pandemic, shortages of raw materials caused by Russian war against Ukraine and low notified body capacity has put a strain on market readiness […] However, all of us here today know that more needs to be done."

Despite a list of 19 mitigating actions by the Medical Device Coordination Group to increase notified body capacity and boost preparedness among manufacturers, without lowering the requirements, and increasing the number of notified bodies from 30 in June to 36 in December for medical devices and from 7 notified bodies for in vitro devices to 8, the current deadline cannot be met without possible shortages of life-saving medical devices and jeopardizing patient safety.

According to the Commissioner, around 23,000 certificates issued under the previous directives have not yet transitioned to that regulation and will expire by 26 May 2024 at the latest.

Many national experts, stakeholders and politicians have been strongly criticizing the deadlines of the new regulations. France, Germany and Ireland have recently submitted a non-paper, which was supported by many other member states.

The key points of the intended legislative initiative to amend the mdr are:

•    Extension of the transition period with staggered deadlines depending on the risk class of the device:
      - 2027 for high risk devices
      - 2028 for medium and low risk devices

•    The extension should be subject to certain conditions. Only devices that are safe should benefit.

•    Removal of the the so-called sell-off date of May 2025 to prevent safe medical devices already on the market from having to be discarded.

The European Commission plans to prepare the legislative proposal by the beginning of 2023, and may enter into effect shortly thereafter.

Additionally, the MDCG has published its Position Paper MDCG 2022-18, focussing on the application of Article 97 MDR to legacy devices for which the MDD/AIMDD certificate will expire before the issuance of a mdr certificate.  

The paper applies to devices with an expired MDD/AIMDD certificate, if the manufacturer has already taken steps to obtain the certification under the mdr, the device has not undergone a significant change in its design or intended purpose; and the device does not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health. Manufactures of such devices can ask a EU Competent Authority (CA) to grant permission for legacy devices to continue being sold in the EU member state where the CA is located.