The European Medical Device Regulation (MDR)
European medical device legislation has been comprehensively revised with the aim of improving the quality of medical devices and increasing patient safety. The result, Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR), came into force on May 25, 2017. By the end of 2023, the MDR had been revised twice.
The first revision was in 2020 due to the emergence of COVID-19 and the associated challenges for healthcare. Further information on the first amendment of the MDR can be found here.
The second amendment of the MDR was initiated in 2023. In order to avoid possible shortages in the availability of medical devices in the EU, an extension was made to transitional period after which medical devices have to comply with the MDR. In addition, the deadline for selling off devices that comply with the EU Medical Device Directive (MDD, 93/42/EEC) was abolished.
Changes as a result of the new MDR
Most of the MDR requirements for developing medical devices and placing them on the market oblige manufacturers to reflect processes and ensure even more comprehensive device documentation.
Nonetheless, the new Regulation holds stakeholders throughout the entire delivery chain, from the manufacturer to the customer, accountable and for the first time also designates specific obligations for importers and distributors.
Among other things, it includes the following reforms to benefit patient safety:
- Unique identification
In order to increase transparency and make it easier to trace and recall devices if there is a safety risk, a new system of unique device numbers is being introduced known as the Unique Device Identification (UDI). Further information on the respective device, such as the manufacturer or risk class, can be looked up in the central European database on medical devices (EUDAMED).
- Focus on market surveillance
The new Regulation pays particular attention to the safety of devices after they are placed on the market. For example, unannounced audits and sample tests by the notified bodies will contribute to device quality, as will the reports that manufacturers have to prepare periodically on device performance and safety, and the considerable reduction in the period for reporting serious incidents from 30 to 15 days.
- Person responsible for regulatory compliance
In accordance with Article 15, every medical device manufacturer and their authorised representative within the EU must each appoint at least one qualified person as responsible for compliance with specific MDR requirements for the company.
- Broader scope and reclassification
In accordance with new rules, manufacturers must re-assess the risk classes of their devices, and may find that they and their device fall into another class such as, for example, the new class Ir for reusable surgical instruments. What’s more, products without an intended medical purpose, such as coloured contact lenses or aesthetic implants, are also now covered which means that they are also now subject to the strict requirements of the MDR.
Frequently Asked Questions (FAQs)
The current Medical Device Directive (93/42/EEC) and the Directive relating to active implantable medical devices (90/385/EEC) required fundamental revision in order to be able to continue ensuring a high degree of patient and user safety. Incidents which received a lot of media coverage, such as the PIP scandal, should be prevented on account of stricter device requirements, greater transparency and unannounced audits.
The Medical Device Regulation defines the requirements for medical devices as per Article 2(1) of the MDR and the associated economic operators. Unlike the Medical Device Directive, the Regulation is a binding legal instrument of the European Parliament, the entry into force of which directly replaces national legislation.
Each device will be assigned a unique identification number (identifier) with coded device information which can be read using a corresponding barcode. It will consist of static information, such as the manufacturer and material number, and dynamic information, such as the expiry date or serial number.
Olympus meticulously tracks the status of the designation of notified bodies in order, where necessary, to define risk mitigation measures which ensure continuous device availability. We are pleased to say that all notified bodies with competence over Olympus have already been designated and are therefore prepared for the MDR:
- 0344 DEKRA Netherlands
- 0086 BSI United Kingdom
- 2797 BSI Netherlands
- 0197 TÜV Rheinland
- 0050 NSAI
Olympus has already put together a project team of experts who will ensure that all devices comply with the MDR within the legal timeframes. Olympus will pro-actively inform customers in good time of any changes to its current range of devices, such as the discontinuation of current devices or the introduction of new devices, ensuring sufficient lead time. Where necessary, alternative solutions will be developed and provided.
Some products might be newly categorized as implantable devices under MDR. The implant card will be accompanied with the product once it has been brought to MDR compliance. The following information will be provided on the implant card:
1. Device name;
2. Device type;
3. Serial number or, where applicable, lot or batch number;
4. Unique device identification (UDI); the UDI as AIDC4 format and the UDI-DI as HRI5
5. Name and address of the manufacturer of the medical device;
6. Website of the manufacturer of the medical device
In addition, the following blank fields will be filled out by the implanting healthcare institution or healthcare provider are available:
1. Name of the patient or patient ID;
2. Name and address of the healthcare institution which performed the implantation;
3. Date of implantation.
Entering data into EUDAMED will be mandatory once EUDAMED has become fully functional. Until this time, various modules will be released for voluntary use:
EUDAMED is structured around six interconnected modules
- Actor registration (released)
- UDI/device registration (released)
- Notified bodies and certificates (released)
- Clinical investigations and performance studies (pending)
- Vigilance and post-market surveillance (pending)
- Market surveillance (pending)