sectors

Healthcare

 

  • CEN-CLC/TC 3 - Quality management and corresponding general aspects for medical devices
  • CEN/TC 55 - Dentistry
  • CLC/TC 62 - Electrical equipment in medical practice
  • CEN/TC 102 - Sterilizers and associated equipment for processing of medical devices
  • CEN/TC 140 - In vitro diagnostic medical devices
  • CEN/TC 170 - Ophthalmic optics
  • CEN/TC 204 - Sterilization of medical devices
  • CEN/TC 205 - Non-active medical devices
  • CEN/TC 206 - Biological and clinical evaluation of medical devices
  • CEN/TC 215 - Respiratory and anaesthetic equipment
  • CEN/TC 216 - Chemical disinfectants and antiseptics
  • CEN/TC 239 - Rescue systems
  • CEN/TC 258 - Clinical investigation of medical devices
  • CEN/TC 285 - Non-active surgical implants
  • CEN/TC 293 - Assistive products for persons with disability
  • CEN/TC 316 - Medical products utilizing cells, tissues and/or their derivatives
  • CEN/TC 362 - Project Committee - Healthcare services - Quality management systems
  • CEN/TC 367 - Project Committee - Breath-alcohol testers
  • 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:

 

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:

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

 

 

Next meeting of the Advisory Board for Healthcare Standards (ABHS) will take place on  2023-04-25 and 2023-04-26 at the Management Centre - CEN-CENELEC in Brussels

Contact:

Jennifer OGBONNA
jogbonna@cencenelec.eu

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