Medical devices 

Safe access to healthcare for patients is a basic right nowadays. Through their more than 20 Technical Committees dedicated to medical equipment, 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 them enable manufacturers to make their medical products compliant with the European legislation in the medical sector, for the ultimate benefit of all European citizens.

CEN and CENELEC contact person: Jennifer Ogbonna 

News and events

Next meeting of the Advisory Board for Healthcare Standards (ABHS) will take place on 23-24 October 2018 in Brussels, Belgium at the CEN-CENELEC Meeting Centre.

Technical bodies and activities

Each CEN and CENELEC Technical Committee in the domain of medical equipment develops European Standards according to a well-defined, dedicated scope. CEN and CENELEC therefore cover a wide variety of medical topics, ranging from electrical medical equipment, syringes, ophthalmic optics and dentistry to air ambulances, in vitro diagnostic medical devices and sterilizers.
Access the full list of CEN and CENELEC Technical Committees operating in the area of medical equipment through the work programme.
 
  • 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

Sector forum

A Sector Forum is a platform aiming at facilitating the exchange of information between the various stakeholders impacted by, involved in or interested in the European standardization activities in a particular domain. It also constitutes a convenient means of coordinating the standardization activities and identifying new standardization needs.
 
In the field of healthcare, the CEN-CENELEC Advisory Board for Healthcare Standards (ABHS) includes medical equipment and eHealth. The Terms of Reference of the 'CEN-CENELEC Advisory Board for Healthcare Standards' (ABHS) were revised in 2012.
 
 

Workshops

  • CEN/WS 87 - Novel methods for isolating wear particles from joint replacements and related devices and for evaluating their biological impact in vitro

European legislation and mandates

Following specific requests – called 'standardization requests' or 'mandates' – from the European Commission, CEN and CENELEC develop European Standards that support the European legislation in a number of domains. The mandated standards are called 'Harmonized Standards' and their references and titles are published in the 'Official Journal of the European Union'.
 
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 (all mandates are accessible in pdf format):
  • 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:

Useful links and documents

 
Harmonized Standards are developed maintaining daily contacts with the European Commission's DG GROW (Unit D.4 'Health technology and Cosmetics).

The DOs and DON'Ts for drafting harmonized standards in healthcare and medical devices - download the presentation (ppt)