Healthcare Sector

The European Healthcare Sector is a complex sector, which encompasses a large variety of products and services. A large number of SMEs operate in this industry sector and UEAPME via its Healthcare Forum seeks to influence the European Institutions so as to guarantee that legislation in this field remains adaptable for SMEs.

UEAPME’s Healthcare Forum

The UEAPME Healthcare Forum brings together European representatives from almost 100,000 manufacturers of custom-made medical devices such as dental and other prostheses, orthopaedic footwear, hearing aids and spectacles. Participants include experts from European healthcare associations, national SME associations and NORMAPME. The Forum sends joint experts to the EU Medical Device Expert Group monitoring the implementation of the medical devices directive, and to the CEN Healthcare Forum in charge of European standardisation in this sector.

Currently, the following associations form the Forum:

Position papers

• January 2007: Comments of UEAPME and the UEAPME NORMAPME Healthcare Forum regarding the Commission Consultation on Community action on health services

• June 2006: Position of the UEAPME NORMAPME Healthcare Forum regarding the suggestion to modify the Commission proposal relating to ANNEX VIII of Proposal for a Directive amending Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

• May 2006: Comments of the UEAPME NORMAPME Healthcare Forum regarding the idea of introducing a general obligation to have a quality management system for manufacturers covered by the Proposal for a Directive amending Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

• March 2006: Comments of the UEAPME NORMAPME Healthcare Forum regarding the Proposal for a Directive amending Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

• June 2005: UEAPME Position Paper in response to the consultation for the revision of the Medical Devices Directive

• August 2004: Comments of the UEAPME-NORMAPME Healthcare Forum regarding the MSOG documents

• March 2004: UEAPME comments on the preliminary draft Commission decision on a European Database on Medical Devices (Eudamed)

• November 2002: Position of the UEAPME Healthcare Forum regarding the revision of the Medical Devices Directive

Press releases

• 27/03/07: Medical Devices Directive: is patient safety a priority for the Parliament? auch verfügbar auf Deutsch


• 07/07/03: UEAPME wants regular third party audits for manufacturers of custom-made medical devices