MDCG 2021-5 Guidance on standardisation for medical devices

The Medical Devices Coordination Group (MDCG) has just published guidance on standardisation for medical devices.

The aim of this document is to guide the various stakeholders in the medical devices sector on the application of standards in order to meet the requirements defined in the applicable European legislation.

The European Commission has also published in the Official Journal of the European Union three implementing decisions dated April 14, 2021, modifying the list of harmonised standards for each of the three directives relating to medical devices. This list has been revised to refer to the most up to date versions of the standards and relates to the following topics:

• Directive 90/385/EEC:

Implementing decision regarding harmonised standards with regard to the biological evaluation of medical devices, packaging for terminally sterilized medical devices, sterilization of health products and clinical investigation of medical devices for human subjects .

Download: Commission Implementing Decision (EU) 2021/611 of 14 April 2021

• Directive 93/42/EEC:

Implementing decision regarding the harmonised standards with regard to medical vehicles and their equipment, anesthesia and respiratory resuscitation equipment, biological evaluation of medical devices, packaging for terminally sterilized medical devices, sterilization of health products, clinical investigation of medical devices for human subjects, non-active surgical implants, medical devices utilizing animal tissues and their derivatives, electroacoustics and electromedical devices.

Download: Commission Implementing Decision (EU) 2021/610 of 14 April 2021

• Directive 98/79/EC:

Implementing Decision regarding the harmonised standards for the packaging for terminally sterilized medical devices and the sterilization of health products.

Download: Commission Implementing Decision (EU) 2021/609 of 14 April 2021

DOWNLOAD GUIDANCE MDCG 2021-5