European Medical Device Regulation

What is the European Medical Device Regulation?

The European Medical Device Regulation (MDR) is Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009.

The regulation, which was published on 5 May 2017 and came into force on 25 May 2017, replaces Directive 93/42/EEC, concerning medical devices, and Directive 90/385/EEC, concerning active implantable medical devices, on 26 May 2021.

Why did MDD change to MDR?

At a basic level EU directives are transposed into national legislation by each member state and this meant that each member state could interpret the directive as they wished, so the MDD was not uniformly implemented across the EU. Regulations, on the other hand, immediately and directly apply in all member states and do not require transposition into national law. In addition, the MDD came into force in 1993 and since then there has been significant changes in medical technology, e.g. software as a medical device (SaMD).

The MDR, therefore, enforces uniformity and addresses the improvements in device capability and technology that has occurred since 1993. The intention is that the MDR helps for a more robust regulation of medical devices.

What is EU MDR compliance?

Since the EU MDR is a regulation, compliance is mandatory for medical device manufacturers, importers and distributers that wish to sell their product on the European market. Compliance with the EU MDR means that the medical device has been assessed by a notified body designated for the MDR which has confirmed that the medical device conforms with all applicable requirements of the MDR.

After 26 May 2021, all devices (new and existing) on the EU market must comply with the MDR.

How does the MDR affect my MDD-certified medical device?

If you have a device that has a CE certificate issued under the MDD, then you can still put the device on the EU market and into service for as long as the certificate is valid. This additional transition period is limited and you can only put the device on the market until May 2024 and into service until May 2025.

What are the EU MDR requirements?

All the requirements for the EU MDR are detailed in the regulation, the document of which is 174 pages long, containing an introduction, 123 articles in 10 chapters, and 17 annexes.

You can also read an interview by ArrowFast Chief Compliance Officer as he reviews the major differences between the MDD and the MDR.

What is MDR certification?

MDR certification of a medical device means that the device has been assessed and has been found to satisfy all the requirements of the MDR. MDR certification is indicated by a CE mark.

Get a Free EU MDR PDF

We’ve prepared a MDR checklist containing the EU Medical Device Certification Process, where you can find all the important steps medical device companies need to follow in order to get a medical device certification in Europe.

European Medical Device Regulation PDF Checklist

What is EUDAMED?

EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.

EUDAMED will be a multipurpose system, functioning as a registration system, a collaborative system, a notification system and a dissemination system (also open to the public) and will be interoperable. The aim for EUDAMED is that there will be more transparency about medical devices that are available on the EU market during the entire lifecycle of the device.

Which notified bodies have MDR designation?

In the European Union, a notified body is an organisation that has been appointed by an EU member state to assess the conformity of medical devices to the technical requirements as laid out in the EU directives or regulations that are applicable to medical devices.

There are already notified bodies that have been “designated” under Regulation 2017/745, and the most up-to-date list of the notified bodies that have been designated can be found in the EU Nando Information System.

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