On February 28, 2019, European Medicine Agency (EMA) (hereafter referred as 'Agency') published the first guidance on new rules for certain medical devices - the first of a series of guidance documents to help applicants to prepare for compliance with these new rules. The first guidance introduces new roles and responsibilities for EMA and national competent authorities (NCAs) in relation to certain types of medical devices and in-vitro diagnostics, demands efforts from the Agency with stakeholders including pharmaceutical and medical device industries, and notified bodies, to ensure a smooth transition to the new regulatory framework.

The new guidance document has been developed jointly by EMA and the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) in close collaboration with the European Commission.

Key points of new guidelines

This guidance document is prepared for the applicants to help them understand the scope of the Agency, its activities and should be read in conjunction with the new medical devices Regulation (EU) 2017/745, and the new In-vitro Diagnostic Medical Devices Regulation (EU) 2017/746. These regulations lay down roles and responsibilities for EMA and National Competent Authorities (NCA) for medicines, as follows:

  • For medical devices incorporating a medicinal substance (with action ancillary to the device) the notified body shall seek a scientific opinion from either the NCAs or EMA. The notified body shall seek the opinion of EMA for medicinal products falling exclusively within the scope of centralized procedure, or those that incorporate human blood or plasma derivatives.
  • For devices that are composed of substances or of combinations of substances that are systemically absorbed by the body in order to achieve their intended purpose, the notified body shall seek a scientific opinion from either the NCAs or the EMA.
  • For companion diagnostics, the notified body shall seek a scientific opinion from either the NCAs or the EMA4.
  • The European Commission may consult EMA when deliberating on the regulatory status of products in borderline cases involving medicinal products.
  • For medicinal products with an integral medical device, there are new requirements to provide an opinion from a notified body.1

Note: This is the first guidance document of the series. EMA will publish further updates addressing other requirements for various categories of devices, including those made of substances that are systemically absorbed, products which are not clearly defined as medicinal products, known as 'borderline products', and in vitro diagnostic tests used to determine patients' eligibility for a specific medical treatment.


This new guidance document published by EMA will help the applicants to carry out the obligations according to the new EU legislation on medical devices. This further introduces the new responsibilities of EMA and national competent authorities.


1. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf

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