Healthcare

Safe access to healthcare for patients is a basic right nowadays. That is ensured through putting on the market medical devices that meet strict safety requirements, as laid down in the three EU Medical Devices Directives: Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic Medical Devices Directives, which have been revised into two new Regulations on Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices revised In Vitro Diagnostic Regulation (EU) 2017/426 (IVDR).

Moreover, it is also of paramount importance that the integrity of the patient and of their health data is protected at all times. Interoperability of health information systems between all the actors and devices, who handle and process health data, is a guarantee that this requirement is achieved.

CEN and CENELEC activities

Through more than 20 Technical Committees dedicated to healthcare, CEN and CENELEC develop European Standards setting safety, quality, and performance requirements for medical devices that are put on the European market. A large number of those standards enable manufacturers to make their medical products compliant with the European legislation in the medical sector, for the ultimate benefit of all European citizens.

Technical Bodies

CEN-CLC/TC 3 - Quality management and corresponding general aspects for medical devices
CLC/TC 62 - Electrical equipment in medical practice
CEN-CLC/JTC 16 - CEN-CENELEC Joint Technical Committee on Active Implantable Medical Devices

EU legislation and mandates

EU Regulations

On 5 May 2017, the European Commission published the new Regulations in the field of medical devices in the Official Journal of the European Union:

EU Directives

In the field of medical equipment, CEN and CENELEC were mandated by the European Commission to develop Harmonized Standards in support of:

Mandates

The following mandates from the European Commission to CEN and CENELEC in the field of medical equipment are currently ongoing.

M/023- Mandate for CEN/CENELEC concerning the development of European Standards relating to medical devices (complemented by M/295)
M/295- Standardization mandate to CEN/CENELEC concerning the development of European Standards relating to medical devices (complements M/023)
M/252- Standardization mandate to CEN/CENELEC concerning the development of European Standards relating to in vitro diagnostic medical devices
M/467- Standardization mandate addressed to CEN and CENELEC: modification and completion of EN 60601-2-52 to prevent entrapment of children and of adults with an atypical anatomy in medical beds and entrapment of children in medical cots

Harmonized Standards

Check the latest lists of Harmonized Standards published in the Official Journal in support of the three medical Directives:

Regulation 2017/745 on Medical Devices(pdf format)
Regulation 2017/746 on In Vitro Diagnostic Medical Devices(pdf format)
Directive 93/42/EEC
Directive 90/385/EEC
Directive 98/79/EC

Download a snapshot, which gives an overview of the Harmonized Standards published over the last six months as well as those intended to be published in the coming months