Last week, ECM Medical Devices Division attended MEDICA, the leading international medtech exhibition, connecting with medical device manufacturers from all over the world to explore new business opportunities and share regulatory opinions.

Great success for ECM at MEDICA 2023. During the 4-day event in Dusseldorf, the staff of Ente Certificazione Macchine had the opportunity to meet its long-standing partners and forge relationships with new customers. At MEDICA, ECM presented its services and activities as Notified Body No. 1282 for the verification of conformity of medical devices according to Regulation (EU) 2017/745 (MDR).  

More than that, the exhibition was an opportunity to engage with medical manufacturers and professionals, creating significant connections and encouraging dialogue around the current regulatory environment.

TOWARDS THE MDR, WHERE DO WE STAND?

The latest “Notified Bodies Survey on certifications and applications (MDR/IVDR)” published by the European Commission reveals that there are almost 23,000 valid MDD/AIMDD certificates that will expire by 2024. The number of MDR certification applications received by notified bodies as of June 2023 is 13,177, compared to 3,899 certificates issued.

In particular, the survey data indicate that:

• The number of incomplete certification applications sent to the bodies remains high (> 50%)
• The time to obtain a new MDR certificate is getting longer (40% of the NBs take 13-18 months to issue a new certificate)
• The number of written agreements signed by the manufacturer with a NB, as of June 2023, is 9,422.

THE NOTIFIED BODY’S POINT OF VIEW

ECM – Notified Body No. 1282 for MDR – gathered the feedback from the many manufacturers who visited our stand at MEDICA, to take stock of the situation and identify critical regulatory issues.

“Regulation (EU) 2023/607, which extends the transition period for MDR, is an important support for the European healthcare system, because it allows to avoid shortages of essential medical devices,” explains Eng. Diego Stevanella, Sales Manager at ECM, “however, manufacturers should not consider this additional time as an opportunity to procrastinate the path towards compliance with MDR requirements.”

Indeed, one of the prerequisites to benefit from the extension is that by 26 May 2024, the manufacturer has submitted a formal application to a notified body, and by 26 September 2024, a written agreement between the parties has been concluded.

“The 2024 deadlines are just around the corner. It is crucial, also in light of the longer timeframe of the certification process, that manufacturers contact a notified body as soon as possible to have their devices assessed under MDR” Stevanella concludes.

To get in touch with ECM – Notified Body No. 1282 – and get more information about our conformity assessment service for the issue of EU certification in accordance with Regulation (EU) 2017/745, contact us at:

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