European Commission website revamped and additional guidance added

More information on regulation of medical devices made available

The Medical Devices Regulation (MDR) - Regulation (EU) 2017/745 - and In Vitro Diagnostic Medical Devices Regulation (IVDR) - Regulation (EU) 2017/746 - were published in the Official Journal of the European Union on 5th May 2017. The Regulatory Framework for medical devices is described on the European Commission’s website. This site provides background to the new Regulations as well as guidance on the Directives for medical devices. The site has recently been restructured and further guidance and information added. The additional guidance, much of which is available in all EU languages, includes:

• Guidance on content of the certificates and the voluntary transfer of certificate. This document indicates that certificates do not have to reference common specifications or harmonised standards if the information is traceable from referenced reports. It also describes the conformity assessment activities that an incoming notified body needs to undertake when a manufacturer changes their notified body.
• An MDR and IVDR infographic,  which highlights some of the new features in the Regulations and identifies issues that need to be kept in mind by different organizations affected by the changes.
• Transition timelines from the Directives to the Regulations illustrated as another infographic that provides a pictorial guide to the transition provisions and the key dates associated with the transition.
• A Factsheet for the procurement of medical devices and in vitro Diagnostic Medical Devices, which is aimed at people within hospitals, clinics, and other organizations responsible for the procurement of medical devices and in vitro diagnostic medical devices.  The document is intended to tell these organizations what they need to know about the changes that are involved and the effect of the changes on purchasing organizations.
• A Factsheet for Authorities in non-EU/EEA States on Medical Devices and in vitro Diagnostic Medical Devices,  which is aimed at regulatory/competent authorities in countries that are not part of the EU/EEA area. The document is intended to provide information to authorities in countries that
  • export devices to the EU who may receive requests for information from manufacturers wishing to place devices on the EU market, or
  • import devices from the EU who need to know about the timelines for implementing the Regulations and the transition provisions.
• A Factsheet for Authorised Representatives, Importers and Distributors,  which describes the roles and responsibilities of each of these important organizations in the supply chain for medical devices.  It also provides some answers to frequently asked questions application to these organizations.

The publication of this guidance for manufacturers is a further reminder that the transition period is marching on and the timelines are set. You need to review the guidance documents that apply to you and see if you need to make any adjustments to your transition plans. Failing to be ready in time could stop you selling your devices in the EU. There are a number of other resources available to help with transition planning, including MHRA’s Introductory Guide to new medical device regulations, MedTech Europe’s flowcharts of the regulations and BSI’s white papers and Compliance Navigator.

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