EPBS is member of the Advisory Board of Healthcare Service (ABHS) of CEN, the European Committee for Standardization. CEN together with CENELEC, the European Committee for Electrotechnical Standardization, provide a platform for the development of European Standards and other technical specifications across a wide range of sectorsincluding healthcare. CEN/CENELEC work closely with the European Commission to ensure that standards correspond with any relevant EU legislation.CEN/CENELEC also cooperate with the International Organization for Standardization(ISO) and the International Electrotechnical Commission(IEC), respectively,to reach agreements on common standards that can be applied throughout the whole world.ABHS is platform for all stakeholders (i.e. EU Commission, Notified Bodies, Industry, MD IVD User) and is moderator for standardization requests via EU Commission. ABHS stipulates standardization activities to fill gaps reported by stakeholders, supports a coherent understanding of horizontal standardization topics (e.g. symbols)and support the introduction of MDR/IVDR.
Report from 25th ABHS Meeting, November 2019 in Brussels:
EPBS has been attended at the 25th meeting of the Advisory Board of Healthcare Standards (ABHS), held on 28th and 29thNovember in Brussels. There was an intensive discussion about implementing standards in MDR and IVDR; how to work with undated references and standardisation requests. Although the standard mandate has not be published yet, the new system starts to produce results and uncertainties get less. CCMC, TC convenors, HAS consultants, secretaries, representative from EC, COCIR and EPBS as stakeholder participated in this meeting. There was also discussion about how to increase healthcare professionals in the TCs and the involvement of professional associations.
For more information about standardisation see https://www.cencenelec.eu/aboutus
- MDR Medical Devices Regulation
- IVDR In Vitro Diagnostic Regulation
- CCMC CEN-CENELEC Management Centre
- TC Technical Committee
- HAS Harmonised Standard
- EC European Commission
- COCIR European Trade Association