The European regulatory scenario is changing rapidly due to the implementation of the new EU Regulation 2017/745. However, while MDR aims to improve the regulatory framework and raise product quality and safety standard, it also introduces new and complex challenges for the entire medical device industry.

CRITICAL ISSUES AFFECTING THE SECTOR

Two are the criticalities emerged with the transition to the new regulation:

• More stringent requirements for manufacturers and the transition of many devices to higher risk classes have led to increased efforts by manufacturers to adapt their products and processes to the new standards required;
• On the notified bodies side, the severity of the requirements to be designated under MDR has meant that accredited bodies are far fewer, while certification activity has increased significantly, both in terms of the quantity of products to be certified and the complexity of the conformity assessment process.

In these circumstances, the risk is that, from 26 May 2024, many devices will no longer be able to be placed on the EU market. To date, in fact, the devices certified under the MDR are about 2,000 out of a total of 23,000 certifications according to the former directives MDD/AIMDD [source Il Sole 24 Ore “Dispositivi medici: l’autogol dell’Europa alla innovazione” – 31 Gennaio 2023 n.30].

In the worst possible scenario, in a little over a year, many products will be withdraw from the European market because they are not certified. This will have an impact on the capacity of hospitals and the health of patients who no longer have access to essential medical devices.

HOW TO KEEP UP

In order to limit the risk of market failures and safeguard the availability of medical devices, the European Commission has proposed an modification to the transitional provisions for some medical devices and in vitro diagnostic medical devices.

However, the proposal, which is currently being examinated by the competent authorities, is subject to the application of special conditions to be met in order to benefit from the amendments. Manufacturers must therefore apply without delay to a notified body for certification.

Ente Certificazione Macchine, Notified Body No.1282 for Regulation (EU) 2017/745 (MDR), accepts new applications for certification to assess the compliance of medical devices with MDR requirements. Considering the increased complexity of the assessment process for the award of this certification, that is to say longer time frames than the previous MDD/AIMDD directives and also more stringent technical requirements, we invite manufacturers to contact us as soon as possible to submit the request for certification.

Contact us for further information at:

Eng. Diego Stevanella – Sales Manager ECM Medical Devices Division

diego.s@entecerma.it | mob. (+39) 393 2471040