Standardisation for medical devices in the EU

A recent European Commission (EC) implementing decision requires the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) to revise existing and draft new harmonised standards for medical devices in light of the incoming device regulations.

The document initially outlines the legal context of the implementing decision and the need for harmonised standards. Annex I lists 201 existing standards which will be revised along with 27 new standards to be developed. All new and revised standards will be adopted on 27 May 2024. In addition, the Medical Device Coordination Group (MDCG) has released guidance to accompany the EC’s implementing decision.

In the guidance, the MDCG highlights the importance of harmonised standards to allow manufacturers, notified bodies and national competent authorities to efficiently and easily complete the various processes required to market a compliant medical device. The document outlines how the harmonised standards will complement the incoming device regulations and how they align with international standards.

The majority of these standards are not legal requirements of the European Union (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Where manufacturers wish to abide by other standards or develop their own, they are free to do so as long as they can show that their chosen standard is compliant with the relevant legislation. However, it is important to note that certain standards are mandatory (such as those relating to symbols and identification colours).

The EC’s standardisation request will be frequently revised in line with the latest European and international standards.

To see how Regulis can help with EU MDR preparedness, click here.