EUDAMED

In May 2021, the European Medical Devices Regulation 2017/745 (MDR) will apply in the world’s second-largest medical device market. The new Regulation will introduce major changes to how medical device manufacturers obtain CE Marking and maintain access to the European market.

The EU MDR will replace the existing Medical Devices Directive (93/42/EEC) [MDD] and the Active Implantable Medical Devices Directive (90/385/EEC) [AIMDD]. The MDR was published in May 2017, marking the start of a 3-year period of transition from the MDD and the AIMDD.

The IVDR will replace the existing In Vitro Diagnostic Medical Devices Directive (98/79/EC) [IVDD]. The IVDR was published in May 2017, marking the start of a 5-year period of transition from the IVDD.

One of the main new features of the Regulations is a completely new system of unique device identifiers (UDIs), improving the identification and traceability of medical devices. It creates a system to uniquely identify medical devices along the supply chain.

As under the current regulatory regime, manufacturers of medical devices take prime responsibility for getting their products CE-marked for the European market. Now, they need to manage the change to get their products CE-marked under the new Regulation.

The MDR has the same basic requirements as the 2 previous Directives. It is generally more stringent than the Directives, especially in terms of risk classes and the oversight provided by notified bodies (NBs). There is also more emphasis on a life-cycle approach to safety, backed up by clinical data and post-market monitoring (‘vigilance’ and ‘post-market surveillance’).

As a manufacturer you will have to start compliance with the MDR by May 2021 (For IVDs by May 2022). It’s important to start the transition as soon as possible. The Regulation allows for transitional provisions if more time is needed due to the high number of devices on the market anticipated bottleneck in reviews by notified bodies ongoing need to interpret certain provisions of the Regulations

An early start is especially important because of the expected pressure on notified bodies during the transition period. Approach your chosen NBs as soon as possible. Check whether they intend to apply for designation under the new Regulation, including the scope they intend to cover, and when they think they will be ready.

We will provide the information you need to help you to comply with the UDI Regulations such as factsheets and step-by-step guide for manufacturers, it includes information and links from third parties such as the Competent Authorities for Medical Devices (CAMD) enabling you to draw up an action plan and start preparing to be ready on time for the MDR.

In addition to the EU MDR our Compliance as a Service also covers both the US FDA and the UK NHS regulations.

The core components of our CaaS service can be listed as follows:-

1. Understand various data requirements.

2. Gather master set of data.

3. Quality check data.

4. Load data.

5. Maintain data over time.

With over 20 years experience implementing GS1 and Unique Device Identification projects we can help you at every stage of your UDI compliance project, even loading the data for you!

If you would like further details on our CaaS service please complete the enquiry form and we will be intouch.