TÜV AUSTRIA Hellas always consistent in updating its customers, informs you about new regulations regarding medical devices (2017/745/EU) and in vitro medical devices (2017/746 /EU), which were issued in May 2017 and will replace the Medical Device Directive (93/42/EEC), the Directive on Active Implantable Medical Devices (90/385/EEC) and the In Vitro Diagnostic Medical Devices Directive (98/79/EC).
The adoption of the new Regulations 2017/745 / EU and 2017/746 / EU in May 2017, marked the start of a three-year transitional period from the Directives on medical devices and active implantable medical products and a corresponding five-year transitional period for in vitro diagnostics medical devices.
Both regulations will come into force gradually. For medical devices, the transitional period ends on 26 May 2020 and for in vitro diagnostic medical devices ends on 26 May 2022.
In order to avoid market disruption and to succeed a smooth transition from directives to regulations, various transitional provisions have been adopted. Certain medical devices with certificates issued under the Directives may continue to be marketed until 27 May 2024 and may be marketed until 27 May 2025.
By May 2025, devices certified under the directives and devices certified under the regulations will coexist on the market. Both will have equal legal status and will not be discriminated against in public tenders.
The new regulations align EU legislation with technical advances, changes in medical science and progress in law-making. They form a robust, transparent and sustainable, internationally recognized regulatory framework that enhances clinical safety and creates conditions for manufacturers to have fair access to the market. Key elements of existing legislation are strengthened such as surveillance of notified bodies, conformity assessment procedures, clinical trials and clinical evaluation, vigilance and market surveillance.
Unlike the directives, the regulations are directly applicable and do not need to be transposed into national law. Therefore, the Regulation on medical devices and the Regulation on in vitro diagnostic medical devices will therefore limit discrepancies in interpretation across the EU market.
- The regulations maintain all the requirements of the directives, but add some new ones. Compared to current guidelines, medical device regulations place greater emphasis on a life- cycle approach to safety, based on clinical data.
- Stricter requirements for the designation of notified bodies are introduced, with increased control and monitoring by the national competent authorities and the Commission. The regulations also clarify the obligations of manufacturers, authorized representatives, importers and distributors.
- Modifies the classification of certain medical devices and has a wider scope. For instance, the regulations explicitly cover all medical devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed disposable medical devices and certain devices with no intended medical use.
- Online sales of medical devices and medical devices used for diagnostic or therapeutic services offered remotely.
- A consultation procedure is established for the clinical evaluation of certain Class IIb medical devices and Class III implantable medical devices by an independent committee of experts.
- The Unique Device Identification (UDI) system will significantly enhance the traceability and effectiveness of post-market security-related activities.
- Increased transparency is provided through the publication of information on medical devices and studies. The new European Medical Devices Database (EUDAMED) will play a central role in improving the availability, quantity and quality of data.
- Factsheet for healthcare professionals and health institutions (pdf)
- Factsheet for Authorized Representatives, Importers and Distributors of Medical Devices and in vitro Diagnostic Medical Devices (pdf)
- Factsheet for Manufacturers of Medical Devices (pdf)
- Factsheet for Manufacturers of in vitro Diagnostic Medical Devices (pdf)
- Factsheet for Procurement Ecosystem of Medical Devices and in vitro Diagnostic Medical Devices (pdf)
- Implementation Model for Medical Devices Regulation Step by Step Guide (pdf)
- Implementation Model for in vitro Diagnostic Medical Devices Regulation Step by Step Guide (pdf)
- Regulation (EU) 2017/745 of the European Parliament and the Council on medical devices (pdf)
- Regulation (EU) 2017/746 of the European Parliament and the Council on in vitro diagnostic medical devices (pdf)
TÜV AUSTRIA Hellas, with specialized staff in the field of medical devices, monitors and updates every detail of developments and always remains at your disposal, with excellent training and knowledge.For more information, you may contact Ms.Paraskevi Papastamataki at 210-52.20.920 (ext. 152) or at email@example.com