The institutions invite medical device manufacturers to undertake the certification process with a Notified Body under the MDR as soon as possible in order to avoid shortages of medical devices on the EU market.

To support the process of adapting the medical system to the MDR requirements and with the aim of avoiding shortages of medical devices on the EU market, in March 2023 EU Commissione adopted Regulation (EU) 2023/607.

This regulation extended the validity period of certificates issued on the basis of the previous Directives until 31 December 2027 or 31 December 2028, depending on the risk class, but only under the condition that:

• the manufacturer submits a formal application to a Notified Body by 26 May 2024,
• a written agreement between the parties for MDR certification of the device is concluded by 26 September 2024.

THE REGULATORY FRAMEWORK

Data coming from the European Commission show that the adoption of Regulation (EU) 2023/607 has not brought the positive effects that were expected. In fact, six years after the entry into force of EU Regulation 2017/745, the number of certificates issued is less than 4,000. This number is considerably small compared to the amount of valid MDD/AIMDD certificates that will expire by 2024 (around 24 thousand). [Source: MDCG – Notified Bodies Survey on certifications and applications (MDR/IVDR)].

WHAT MEDICAL DEVICE MANUFACTURERS HAVE TO DO

In a note dated 23 November 2023, the Italian Ministry of Health urged manufacturers to speed up the process of compliance with EU regulations and not to further delay the submission of medical device certification applications.

The Ministry also pointed out that if certification applications were submitted in large numbers close to the 26 May 2024 deadline, it would create an excessive burden for the Notified Bodies, which would presumably not be able to guarantee on time the signing of the contract between the parties – essential to continue marketing.

THE NOTIFIED BODY’S PERSPECTIVE

Recently, our Technical Manager of the Medical Devices Division, Eng. Vanessa Biavati, attended an institutional meeting organised by the Ministry of Health, which involved Accredia and all Italian Notified Bodies. The agenda included an in-depth discussion on aspects related to the transitional period and the actions taken in Italy and in the European Union.

As Notified Body No. 1282 for the MDR regulation, Ente Certificazione Macchine is carrying out its certification activities, keeping in close contact with other international players on the main regulatory focuses, in order to bring its own contribution to the legislative panorama.

ECM also stresses the importance for manufacturing companies to submit their certification applications timely, in order to be prepared for the deadlines set out in Regulation (EU) 2023/607 and to avoid stops in the marketing of medical devices on the EU market.

If you have any questions about the MDR transition of your medical device or if you would like to start the certification process, please do not hesitate to contact us at:

Diego Stevanella – Sales Manager ECM – diego.s@entecerma.it | (+39) 393 2471040