Brussels, 26 March 2020
COCIR welcomes the European Commission’s announcement that it seeks to postpone the Medical Device Regulation’s Date of Application by a year. This move will assist the medical device industry in its efforts to continue supporting patients, healthcare professionals and hospitals in their fight against COVID-19. Our member companies have increased production to ensure the continuous supply of critical equipment (respiratory assistance devices - ventilators), patient monitoring systems, supplies and where necessary portable X-ray, ultrasound and Computed Tomography (CT) equipment.
In recent years, COCIR members have made significant efforts to ensure they will be compliant with the new Medical Device Regulation. However, the current COVID-19 crisis has created a clear and unprecedented disruption to these preparations, including:
• Increased consumption caused by COVID-19 is depleting stocks of medical devices placed on the market under the ‘warehousing clause’ intended to bridge the gap between the current Directives and the Regulation. Current shortages of certain devices will continue until after May 2020.
• Travel restrictions and quarantine requirements in many countries mean that manufacturing sites cannot be accessed, nor are Notified Body auditors and company employees available to perform audits. The result is the cancellation of audits and therefore delays in MDR certification and certification renewals under the Medical Device Directives.
• The infrastructure to support medical device companies in becoming compliant (e.g. testing laboratories) faces challenges in providing their services.
• Clinical studies are put on hold as healthcare organisations and their staff prioritise the fight against COVID-19.
A unified solution is required to ensure continuity of patient care by preventing distortion in the European Single Market. We urge Member States and European Parliament to support the European Commission in this initiative and we encourage them to swiftly adopt this postponement. During the prolonged transition period, the current Medical Device Directives must remain valid.
We welcome the European Commission's initiative to speed up publication of harmonised standards for certain medical devices to respond to the coronavirus outbreak. Timely harmonisation of state-of-the-art standards is key for placing medical devices on the European market and ensuring a high level of protection of health for patients and users. COCIR will willingly support any action to address the large backlog of harmonised standards to support the regulatory framework for medical devices.