Don’t get lost in EU Medical Device regulation harmonisation

by Paolo Pescio, Senior Consultant - Medical Devices, Eurofins Medical Device Testing

Harmonised standards (HS) are one of the key pillars of the European regulatory approach to medical devices. HSs are European standards developed at the request of the European Commission to the European Standards Organisations (e.g., CEN). In line with the pivotal James Elliot legal case judgment, HSs are now seen as measures of European Union law, and the publication of an HS takes a form of an “official” European Commission decision.

The references of HSs are published in the Official Journal of the European Union, and the last publication in the medical device field is dated November 2017 with 159 standards cited for the Medical Device Directive, 37 for In Vitro Diagnostic and 36 for Active Implanted Medical Devices. More than 170 European standards were refused to be published due to a lack of compliance.

No standard is yet harmonised for the “new” Medical Device Regulation (MDR) because of a lack of an official mandate from the Commission to the European Standards Organisation to develop standards in compliance with the MDR. The mandate is expected to be ready within the first half of this year, and it will be based on a step-wise approach with a prioritisation of standards.

The top priority topics are the quality management system (EN ISO 13485), risk management (EN ISO 14971), symbols and labelling (EN ISO 15223-1 and EN 15986), and good clinical practice (EN ISO 14155) with the aim of having these standards harmonised as soon as possible or at least by the end of the “transition period” (May 2020). Other horizontal standards (e.g., ISO 10993 series) are expected to have longer periods--in view of the Technical Committee work plans--to be harmonised. Semi-horizontal and product-specific standards will be last to be harmonised.

Having less than one year for the top priority standards from the mandate to the full implementation of MDR could be an issue. To meet the deadline and avert the risk of not having HSs, the Commission created a pool of technical consultants to support the entire cycle of the development of harmonised standards.

Eurofins Medical Device Testing experts are happy to support manufacturers facing MDR, providing testing and offering regulatory expertise during the entire medical device life cycle.