EU’s Medical Device Regulation (MDR)

The Medical Device Regulation (EU) 2017/745, also known as MDR, is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. After several years preparing an agreement with all the EU members, on April 5, 2017, the EU adopted the Medical Device Regulation, which replaced the two existing directives: the Medical Devices Directive and the Active Implantable Medical Devices Directive.

When working under the Medical Devices Directive and the Active Implantable Medical Devices Directive, each member country could independently understand and interpret the directives. Under the new Regulation, this does not happen. The objective of MDR was to create a unified regulation for quality indicators and post-marketing surveillance of medical devices used in the European Union.

With this change, new needs arose. Manufacturers are now required to have technical documentation in compliance with the GSPR and to obtain registration in EUDAMED and its UDI-DI/Basic UDI. Also, manufacturers not in the EU must now have an EU Authorized Representative. Various changes have been established in the MDR, and the Medical Device Coordinating Group (MDCG) periodically issues clarifications or addendums to the MDR. Therefore, it is important to be aware of new regulations and developments to ensure medical devices are in compliance with the Medical Device Regulation (EU) 2017/745

Key changes

The Medical Devices and Active Implantable Medical Devices Directives did not foresee the use of new technologies, or new uses of an old technology. Changes introduced by the MDR include:

EU MDR Timelines

General

Implementation for Label and Packaging

Implementation for Direct Marking and Reusable Devices

Technical file structure

Download the Technical File Structure to comply with the new MDR for free!

Most common questions about Europe Medical Device Regulations:

UNDER THE NEW MDR, CAN MY DEVICE BE RE CLASSIFIED?
Yes, under the new MDR, every manufacturer must check if their device is still under the same classification, or if anything changed. QSG can support you preparing an EU Regulatory strategy document with your classification and with all documents your device must have in order to be placed in the EU.

WHAT IS THE EUDAMED? AND THE UDI?
EUDAMED is the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on medical devices for in vitro diagnostics and developed by the European Commission. The objective of this database is to provide the traceability for each medical device, and to facilitate the flow of information between all the actors (medical devices manufacturers, authorized representatives, importers, distributors, Notified Bodies, EU member states, and the European Commission). EUDAMED major achievement is the registration of products with a unique UDI (Unique Device Identification).

WHAT ARE THE NEW REGULATIONS FOR THE REUSE OF MEDICAL DEVICES?
Under the MDCG  2019-15 rev.1, aspects related to cleaning, disinfection, sterilization, maintenance, function testing, and related operating instructions must comply with Annex IX and Annex XI. This means that under the new MDR, manufacturers are not allowed to determine for themselves which devices fall into the Class Ir category. To acquire a new CE mark for a Class Ir device, the technical file must therefore undergo inspection of a Notified Body, so that it corroborates compliance with “Reusable”.

WHAT IS THE NEW CLASSIFICATION RULE IN THE MDR THAT APPLIES ONLY TO SOFTWARE?
Under the MDD, software was classified as Class I, but under Rule 10 of the MDR, software designed to provide data used to make decisions for diagnostic or therapeutic purposes is now classified as Class IIa. In turn, if those decisions have implications that may directly or indirectly cause death or cause irreversible deterioration of health, the software is now classified as Class III.

WHAT PRODUCTS WITH A SOLELY AESTHETIC OR NON – MEDICAL INTENDED USE ARE NOW COVERED BY THE MDR?
Under the MDR, aesthetic products or products for non-medical use that are similar in function and risk profile to products intended for medical use are covered by this new regulation. The list of these products is extensive and will be expanded based on new technological advances. They include color contact lenses, aesthetic treatments, dermatological fillers and others.

WHEN DO MEDICAL DEVICE MANUFACTURERS NEED TO COMPLY WITH THE REQUIREMENTS OF THE NEW MDR?
As of May 26, 2021, manufacturers and new products already had to comply with the new MDR requirements to be marketed in the European Union. Medical devices that have a CE Certificate still in force can be on the market until that certificate expires. However, all documentation submitted to health authorities, such as post-marketing surveillance, must comply with the new MDR format.

HOW CAN MANUFACTURERS PREPARE FOR THE NEW MDR?
To successfully transition from IVDD to IVDR, manufacturers must have a comprehensive and detailed management plan. Quality and Regulatory aspects must be considered, depending on the device classification. It is key for specialized third-party auditors to conduct internal audits in order to have an overview of the quality system and ensure compliance with the MDR. A GAP analysis to evaluate needs for technical documentation is also a fundamental step.

Steps to go to the market when you have your device under MDD/IVDD

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