Update on the Interpretation of the Medical Devices Regulation

by Dr Gisela Grabow

A few days ago, the EMA published the document "Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)" (Q&A). This document provides practical considerations for the implementation of the MDR and IVDR and is an important guide for companies on how to implement the MDR in terms of issues that are not directly apparent from the MDR.

The Q&A document covers:

  • Medical devices that form an integral product with a medicinal product,
  • Medicinal products containing a medical device in the secondary packaging of the marketed medicinal product.
  • Consultation procedures for substances with an ancillary function, which are an integral part of medical devices.

For example, the following questions are answered:

  • When is my medical device considered an integral product with a medicinal product?
  • Do I have to submit a (new or updated) EU Declaration of Conformity / EU Certificate / Notified Body Opinion if changes are made to the medical device (or medical device part) after the initial authorisation of the medicinal product-medical device combination?
  • What medical device labelling requirements apply to medical devices that are "co-packaged" with a medicinal product

Regarding the key requirements that the MDR places on companies, we would like to refer to our previous blog post. We will keep you updated on any news by EMA and the EU Commission as regards the application of the MDR and IVDR.

Our blog contributions shall provide an overview with regard to legal topics, legislation and case law and are supposed to provide some general information rather than constituting any specific advice. Please do not hesitate to contact Maiwald and in particular the authors of the particular contributions if have any questions on the addressed topics or on other legal issues.