The European Committee for Standardization (CEN) provides a platform for the development of European Standards and works closely with the European Commission to ensure that standards correspond with any relevant EU legislation. CEN also cooperates with the International Organization for Standardization (ISO) to reach agreements on common standards that can be applied throughout the whole world, thereby facilitating international trade.
Standards are all around us, even if we are not always aware of them. All European laboratories have to adhere to the EU Regulation in standards in Medical Devices (MDR) and In Vitro Diagnostics (IVDR). Standards improve safe access to healthcare for patients which is a basic right nowadays. Not only many Technical Committees (TC) are working on standardization, also the Advisory Board for Healthcare Standards (ABHS) in which EPBS is stakeholder.
On November 30, 2020 ABHS held its 27th meeting, due to the pandemic not physical but virtual. There was an intensive discussion about implementing standards in MDR and IVDR; how to work with undated references and standardisation requests. CCMC, TC convenors, HAS consultants, secretaries, representative from EC, COCIR and EPBS as stakeholder participated in this meeting.
An advantage of a virtual meeting is that it is very efficient and more people attend because it is less time consuming (no travelling). Therefor the participation of EC representative, Mario Gabrielli Cossellu, is highly appreciated by the ABHS. He presented: “Medical devices standardisation – state of play” We had an open and constructive discussion.
For more information about standardisation see https://www.cencenelec.eu/aboutus
CCMC CEN-CENELEC Management Centre
HAS HArmonised Standard
EC European Commission
COCIR European Trade Association