The European Medical Device Regulation (MDR)
European legislation regarding medical devices has been extensively revised in order to improve the quality of medical devices and increase patient safety. The result, Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, came into force on 25 May 2017 and was planned to be implemented in full as of 26th May 2020. Due to COVID-19 and the associated public health situation, Member states, constitutes, national authorities, health institution, Union citizens and Economic Operators are confronted with an immense burden. Therefore, it has been decided on European level to grant the affected parties another 12 months to implement the requirements of the MDR. The new date of application of the MDR is the 26th May 2021. For further information please refer to the official journal of the EU.
The current Medical Device Directive (93/42/EEC) and the Directive relating to active implantable medical devices (90/385/EEC) are being repealed and replaced by the Regulation, whilst EU Member States are simultaneously revising their national legislation on medical devices in order to reflect the changes under the MDR.
The changes resulting from the new MDR
Most of the MDR requirements concern the development and placing on the market of medical devices and oblige manufacturers to reflect on their processes and ensure that they provide even more comprehensive product documentation with the device.
Nonetheless, the new Regulation places responsibility on all stakeholders involved across the entire supply chain, from the manufacturer all the way through to the customer, and for the first time ever also sets out specific obligations for importers and distributors.
The following are some of the new developments designed to improve patient safety:
- Unique identification
A new system with unique device numbers will be introduced over the next few years in order to increase transparency and make it easier to trace and recall devices which present a safety risk. It is called the Unique Device Identification (UDI) system. It is anticipated that it will be possible to consult further information about the relevant device, such as the manufacturer or the risk class, in the central European Database on Medical Devices (EUDAMED) from mid 2022.
- Focus on market surveillance
The new Regulation places special focus on the post-market safety of devices. As such; unannounced audits and sample tests by notified bodies; periodic reports which must be drawn up by manufacturers regarding the performance and safety of their devices; and the significant shortening of the timeframe within which serious incidents must be reported from 30 days down to 15 days will all contribute to improving device quality.
- 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.
Customers are always at the heart of everything that Olympus does. Olympus has been preparing for the MDR-related migration, at global level, for a long time in order to ensure continuous device availability. Olympus will make use of the transitional periods for the migration to the MDR (see graphic).
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 then, the different modules will be released for voluntary participation:
EUDAMED is structured in six interconnected modules and a public website:
- Actors registration (launched for voluntary registration)
- UDI/Devices registration (pending)
- Notified Bodies and Certificates (pending)
- Clinical Investigations and performance studies (pending)
- Vigilance and post-market surveillance (pending)
- Market Surveillance (pending)