Standards and the Single Market: the power of standards for a healthier EU

On this World Health Day, CEN and CENELEC examine how standards help strengthen healthcare in all parts of Europe.

On 7 April, CEN and CENELEC are celebrating World Health Day, commemorating 75 years since the establishment of the World Health Organisation. Since then, advances in healthcare and wellbeing have led to improved quality of life for people all over the world. The tireless efforts of scientists and healthcare experts into creating innovative and life-saving healthcare solutions and technology have been a strong driver of these advances. And since the establishment of the Single Market, standards have helped foster these innovations and ensure that every part of Europe could benefit by facilitating their free movement.


Many CEN and CENELEC technical committees work on a variety of healthcare areas, from CLC/TC 62 on electrical equipment in medical practice to CEN/TC 140 on in-vitro diagnostic medical devices. Harmonised standards have also been used to support important healthcare regulations in the Single Market, such as the Regulation 2017/745 on Medical Devices and the Regulation 2017/746 on In-Vitro Diagnostic Medical Devices. European Harmonised Standards provide a presumption of conformity that helps manufacturers to comply with European legislation, building trust among European consumers in this sensitive yet vital sector.

In the thirty years since its establishment, the Single Market has faced several challenges and crises. Most recently, the COVID 19 pandemic was an enormous and complex test to every facet of European life. To help Europe face this challenge, CEN and CENELEC proved the effectiveness of the European Standardization System, by providing in record time a number of standards on personal protective equipment and respirators. This decision has allowed to speed up the production of key materials needed in the emergency phase of the pandemic.


But looking to the future challenges posed by ever changing healthcare needs and the impact of digitalisation, standards will continue to play a central role. CEN and CENELEC have already began work on these future topics in healthcare, from creating a CEN workshop agreement on Digital health innovations to setting up a CEN and CENELEC focus group on the futuristic topic of “Organ on a Chip” after a successful workshop in collaboration with the European Commission’s Joint Research Centre (JRC).


CEN and CENELEC are proud to produce standards that play a central role in keeping the Single Market healthy. Stay tuned to learn more about the different ways they can do that with our 30 Years of Standards Supporting the Single Market campaign, or join the conversation through the hashtag #SingleMarket30.



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