In view of the recently published Medical Devices (MDR) and In Vitro Medical Devices (IVDR) Regulations, the CEN and CENELEC Advisory Board for Healthcare Standards (ABHS) has revised its Strategy to 2020. With its updated strategy, ABHS seeks to support the CEN and CENELEC Technical Boards in taking well-informed decisions and in shaping appropriate technical policies in the healthcare sector.
In the remaining period to 2020, the following areas will be a key focus for ABHS:
- Support standardization work towards advancing patient, and user-benefit & safety.
- Actively support the transition to the new landscape under the MDR and IVDR, including the future standardization requests.
- Actively encourage timely citation in the Official Journal of the European Union (OJEU) of up-to-date internationally recognized standards for medical devices providing presumption of conformity, which is essential to avoid fragmentation of the medical devices market, as well as encourage other work to support these objectives, such as the work of the Medical Devices BT Task Group.
- Strive to increase ABHS’ membership and actively encourage the sharing of knowledge across all stakeholder groups, particularly Technical Committees (TCs), manufacturers, healthcare professionals, competent authorities, conformity assessment bodies and the European Commission.
- Stay informed about developments made in the CEN Healthcare Services Focus Group.