Standards and common specifications
The use of harmonised standards is voluntary, but it is only when harmonised standards are met that a device is considered to be in accordance with the requirements covered by the standard.
The regulations of medical devices are limited to laying down the essential requirements for the properties of medical devices placed on the market in Europe.
The technical details and solutions that support the essential requirements are described in:
- European harmonised standards prepared by the designated European standardisation organisations CEN and CENELEC
- The monographs in the European Pharmacopoeia, in particular
- surgical sutures
- interaction between medicinal products and materials used in devices containing such medicinal products
A device is considered to be in conformity with the requirements if it is designed and manufactured in accordance with relevant harmonised standards and monographs published in the Official Journal of the European Union (OJEU).
The application of standards also applies to requirements for systems or processes that economic operators or sponsors must meet, such as:
- Quality management systems
- Risk management
- Post-market surveillance systems
- Clinical trials
- Clinical evaluation or clinical follow-up after the device has been placed on the market
The use of harmonised standards is voluntary, but only devices that are in conformity with the relevant harmonised standards shall be presumed to be in conformity with the requirements covered by the standard. When using other standards or solutions, the manufacturer must document that the solution fully meets the requirements.
The relationship between the requirements of a harmonised European standard and the medical device regulation is described in the foreword of the individual standard, and in particular in a separate annex, called Annex Z.
Annex Z contains:
- one or more tables showing the correspondence between the standard and the medical device regulation
- comments that are necessary for the correct use of the standard, such as if some legal requirements are not covered, or only partially covered by the standard
For more information on the standardisation of medical devices, see MDR Article 8 and MDCG 2021-5 Guidance on standardisation for medical devices.
The list of harmonised standards can be found on the European Commission's website for harmonised standards. The pages with standards for medical devices can be found under «Healthcare engineering».