The latest directive on medical devices issued in the European Union is the Medical Device Regulation (MDR) 2017 / 745. This regulation combines the current directive 90 / 385 / EEC with the implantable active medical devices (AIMDD for short) and the directive 93 / 42 / EEC for medical devices (MDD for short).
This final arrangement is very comprehensive and the process of a medical device before it is placed on the market is determined as follows:
- MDR scope assessment
- Risk class assessment
- Determination of applicable safety and performance requirements
- Selection of conformity assessment procedure
- Preparation of technical documentation
- Implementation of conformity assessment procedure
- Assignment of UDI-DI (individual device identification system, device identifier)
- Preparation of declaration of conformity, and
- CE marking affixing
- UDI-PI attachment (single device identification system, production identifier)
Medical devices are classified in the MDR directive as follows: non-invasive devices, invasive devices, active devices and special rules. There are also important changes in the classification rules compared to the previous regulations.
In the preparation of the medical device regulation 2017 / 745, it was aimed to ensure the functioning of the market for medical devices without disruption, taking into consideration the protection of the health of patients and users and the observance of small and medium-sized enterprises operating in this sector. This regulation also sets high standards of quality and safety to address safety concerns with medical devices.
The MDR directive differs significantly from the regulations of the European Union in the field of medical devices and active implantable medical devices.
First of all, the scope of the new arrangement has been wider. Other non-medical devices and equipment such as cosmetic implant devices and color contact lenses have also been included. Product safety, quality and usage performance are kept at the highest level within the borders of the European Union and new legal regulations encourage the development of manufacturers. Within this framework, the certification bodies have been obliged to inspect the manufacturer companies unannounced. In this respect, manufacturing companies must produce safe products and show documents proving this situation.
Another innovation introduced by the MDR regulation is the establishment of a data system called EUDAMED. EUDAMED is a database designed by the European Union and required entry. Detailed information such as clinical data for medical devices and after-sales surveillance results will be entered into this data system. In this way, all information related to medical devices is made available to the persons concerned.
In the new regulation, issues such as product safety tests, risk analysis studies, clinical evaluation results and post-market follow-up are prioritized. In addition, new strict rules have been introduced in the identification of notified bodies.
There are other innovations in the MDR regulation. For example, manufacturers must now have a qualified staff responsible for ensuring legal compliance in their staff. Additional requirements for the re-labeling or repackaging of medical devices are introduced. Device Single Identity (UDI) system has been introduced to ensure the traceability and security of medical devices. The reprocessing of disposable equipment has been recognized as the production of new devices.
In addition, the criteria of the laboratories to operate in the field of medical devices have been determined. These laboratories will play an important role in both certification and market surveillance activities. These laboratories will be appointed by the European Commission.
A calendar has been set for the transition to the new regulation. Accordingly, 26 May 2020 will be subject to the certifications issued under the previous directives. After this date, devices can now be introduced to the market under the MDR directive.
Our company also provides MDR medical device certification services within the scope of other certification services. Thanks to these services, enterprises are able to produce more efficient, high performance and quality products in a safe, fast and uninterrupted manner.
MDR medical device certification services provided within the scope of other certification services are only one of the services provided by our organization in this respect. Many other certification services are also available.