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
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:
- The EU database – EUDAMED — where medical device traceability is achieved by assigning UDI-DI and basic UDI, achieving unique device identification. This greatly favors coordination between EU countries in the fields of surveillance and market surveillance.
- New designation criteria and supervisory processes for Notified Bodies, so that they all have the same high base, which had previously been lost in some countries.
- Stricter ex-ante control for high-risk devices through a new pre-market control mechanism involving an EU-level group of experts
- The introduction of an “implant card” that contains information on medical devices implanted for a patient, achieving broad traceability of the devices and being able to provide a better post-marketing surveillance service.
- The inclusion of certain aesthetic devices that have the same characteristics and risk profile as similar medical devices in the scope of application of this Regulation, as well as the inclusion of non-medical products.
- The strengthening of the rules for clinical trials, including an EU-wide coordinated procedure for the authorization of multicenter clinical investigations. The Clinical Evaluation Report, better known as CER, and the Post Market Follow UP, PMCF have taken a central value in the approval of the Technical File for the MDR.
- In turn, the post marketing surveillance (PMS) with the new requirements has managed to be a model to include new concepts in risk management.
- Risk Management has taken on a crucial value for the Technical File, and for the condensation of the results, being a fundamental piece for the fulfillment of the corresponding classification.
EU MDR Timelines
- 26th May 2021: Date of application of the EU MDR. This come from the original deadline was 26th May 2020, and was delayed due to the coronavirus pandemic.
At the beginning of 2023 the European Parliament approved the new MDD grace periods for devices which currently have a CE mark under MDD.
- 31 Dec 2027: certificates issued under MDD for high risk devices become void.
- 31 Dec 2028: certificates issued under MDD for low risk devices become void.
- All new devices must go under the MDR and haven’t got a grace period.
Implementation for Label and Packaging
- 26th May 2021: deadline for medical devices Class III and implantable
- 26th May 2023: deadline for Class IIa and IIb devices
- 26th May 2025: deadline for Class I
Implementation for Direct Marking and Reusable Devices
- 26th May 2023: for Class III and implantable
- 26th May 2025: for Class IIa and IIb
- 26th May 2027: for Class I
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
- TECHNICAL DOCUMENTATION UPDATE
Perform a GAP analysis to know the status of the Technical Documentation.
With this we will be able to evaluate what information is missing to comply with the requirements of the new Regulation. This also includes the Clinical Evaluation (MDR) or Performance Evaluation (IVDR), labeling, marketing material, and all the documents related to Post-Marketing Surveillance.
- QMS UPDATE
Carry out an internal audit with an external auditor to evaluate the status of the Quality Management System (QMS). It is important to comply with ISO 13485 but also with the internal requirements of the Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, which exceed ISO 13485.
- OBTAIN THE CE MARK
If it is necessary for the Notified Body to issue the CE mark, this is the time to submit the documentation.
Note: It is important to keep in mind that there is a delay in the evaluations of the notified bodies. The sooner the appointment can be obtained the better it will be. Likewise, it is necessary to evaluate the time it will take to remedy the technical documentation and have the quality system in accordance with the new regulation.
In the case a of self-certified device, the manufacturer must issue the Declaration of Conformity in compliance with the Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
- AUTHORIZED REPRESENTATIVE, IF NEEDED
If the manufacturer is not EU based, it will be mandatory to contact an EU Authorized Representative.
- MAKE THE REGISTRATION
Once the CE marking is obtained, it must be registered with EUDAMED and in the database of a member country. In the case of an EU based manufacturer, it is carried out by the same manufacturer. If the manufacturer is non-EU based, it must be done by the EU Authorized Representative.
- GO TO THE MARKET
QSG will support you in every step for having your device on the market in compliance with the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).