Much like the FDA oversees approval of medical devices in the United States, the EU Notified Bodies and the national health authorities are responsible for regulating medical devices in the EU. The main gauge for safety and performance in the EU is established by a conformity assessment which is conducted by accredited Notified Bodies designated by EU Member States. Typically, under “normal” circumstances, this assessment involves an audit of the manufacturer’s Quality Management System (QMS) and a review of technical documentation on the safety and performance of the device. If the medical device complies with the member state’s regulations and the manufacturer passes their conformity assessment, the product will be given a CE (Conformité Européenne) mark which allows the medical device to be sold to the public. There are more specific approval requirements depending on the type of product, but this is a snapshot of the overall approval process.
Due to the urgency required to combat COVID-19, the European Commission (EC) is temporarily allowing certain medical devices to be sold without the CE mark. Non-CE marked Personal Protective Equipment (PPE) can be sold to the public under certain circumstances, including PPEs that may have been in the process of getting the CE mark but were not fully finalized, where the Competent Authority finds the product ensures an adequate level of health and safety in accordance with EU law. In this case, the manufacturer needs to make a request to their EU member state notified bodies and or/competent authorities to allow temporary EU market access. Each member state treats these emergency provisions a bit differently, for example in Spain, the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) does not authorize their use at all.
Other exceptions include medical devices used in combatting the pandemic where there are no alternative products or treatments currently available on the EU market. In this case the manufacturer needs to make a request to their EU member state Notified Bodies and or/competent authorities to allow temporary EU market access. In an effort to streamline the auditing progress, Notified Bodies are now authorized to perform audits remotely which cuts down on human to human contact and speeds up the processing timeline. All Notified Bodies have been instructed to prioritize conformity assessments for PPEs and medical devices aimed at helping in the fight against COVID-19.
One of the most impactful pieces of news to come out of the EU in recent weeks was a proposal by the European Commission to delay the Medical Devices Regulation (MDR) conformance deadline for an entire year - until May 26, 2021. This proposal is expected to be voted on tomorrow, April 16, and would be a godsend for any companies that have not yet updated their manufacturing processes to conform to the new regulations. The EC was quick to point out that this deadline change will not alter the requirements of the MDR, nor will it introduce any new areas for compliance. Stella Kyriakides, Commissioner for Health and Food Safety, said in a statement: “Our priority is to support Member States to address the coronavirus crisis and protect public health as powerfully as possible – by all means necessary. Any potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided.”