Updated guidance on medical device borderline and classification issued

New edition of the EU manual providing interpretation under the Directives now available

Competent Authorities in the Member States are responsible for defining whether a given product is a medical device and interpreting the classification rules when the product is placed on the market in their country.  However, this means that different interpretations can occur, leading to implementation that is not uniform. Consequently, it was agreed that there was a need for a forum for discussion among the regulators and industry to try and achieve consistency. The Commission, Member States and other stakeholders concluded that guidance is needed which goes beyond abstract rules and addresses their actual application.

A Working Group, chaired by the European Commission and including representatives of Member States of the European Union and the European Free Trade Area as well as other stakeholders, has produced guidance on classification and borderline issues in the form of a manual. Version 1.18 of the manual was published in December 2017. This manual represents the consensus of the regulators in this group on products that have raised questions, following consultation with stakeholders. The guidance in the manual is not legally binding but is intended to be used as a tool for reference by Member States to use in adjudication on individual cases.

The full title of the manual is ‘ EU Manual on borderline and classification in the Community regulatory framework for medical devices’ and it provides guidance interpreting the Directives for medical devices when:

• it is not clear whether or not a product is a medical device, an active implantable medical deviceor an in vitro diagnostic medical device;
• the product falls within the definition of a medical device but is excluded from the Directives by their scope;
• claims of a medical nature are made for a product but these claims cannot be substantiated by technical, clinical and scientific data;
• there is difficulty in the uniform application of the classification rules; or,
• different classifications occur based on interpretation of the rules.

The guidance in the manual covers:

• consideration of whether certain products are medical devices, in vitro diagnostic medical devices or accessories;
• the borderline between the Directives for medical devices, active implantable medical devices and in vitro diagnostic medical devices;
• the borderline with medicinal products;
• the borderline with biocides;
• the borderline with cosmetics;
• classification; and,
• software and mobile applications.

The manual provides a useful resource and reference source. The content has been built up over years of applying the Directives for medical devices. It is helpful to keep up to date with the interpretations and the thinking behind them. It is important to note that the manual only applies to the Directives. The experience in the manual has fed into the development of the Medical Devices Regulation (MDR) and In Vitro Medical Devices Regulation (IVDR) but changes in the definitions and classification criteria mean that the current guidance in the manual might not be applicable to the new Regulations. Where the Directives and Regulations remain aligned, it is expected that the manual will still be applicable.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.