Healthcare

• 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 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:

• Regulation 2017/745 on Medical Devices
• Regulation 2017/746 on In Vitro Diagnostic Medical Devices

EU Directives

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

• Directive 93/42/EEC on Medical Devices
• Directive 90/385/EEC on Active Implantable Medical Devices
• Directive 98/79/EC on In vitro Diagnostic Medical Devices

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