What are your obligations under the new EU MDR and IVDR?

Introductory Guide to new medical device regulations launched by UK MHRA

Previous blogs have followed the countdown to publication of the EU Regulations for Medical Devices (MDR) and In Vitro Diagnostic devices (IVDR). These regulations entered into force on 25 May 2017, the three- and five-year transition periods are now underway. The new regulations will apply across EU Member States from 26 May 2020 and 2022 respectively. The Medicines and Healthcare products Regulatory Agency (MHRA) has created an Introductory Guide to make sure manufacturers are aware of their obligations. The Introductory Guide, designed as an interactive pdf, will help new manufacturers who may be looking at the regulations for the first time as well as assisting experienced manufacturers navigate the changes in the new regulations. As well as guidance, there are links to further information.

In simple terms, the Introductory guide describes six steps to placing a medical device on the market:

1. Pass conformity assessment;
2. Draw up declaration of conformity;
3. Place CE-mark on device;
4. Get unique device identification (UDI);
5. Enter information into European database (Eudamed); and,
6. Place device on the market.

The Guide describes the timelines for implementation, provides definitions, and outlines the processes for classification of devices and conformity assessment. It also describes the obligations of organizations along the supply chain: manufacturers, authorised representatives, importers and distributors. Additionally, it covers the requirements for post-market surveillance and vigilance reporting by the manufacturer, and market surveillance by competent authorities, which were also addressed in a recent blog post. Additionally, the Guide has further information on UDI and the Eudamed database.

The publication of this MHRA Introductory Guide is a further reminder that the time for prevarication is over and the timelines are set. You need to start implementing your transition plans. Failing to be ready in time could stop you selling your devices in the EU. In addition to the MHRA Introductory Guide, BSI’s free white papers and Compliance Navigator can also help you. 

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.