Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices entered into force on 26 May 2017. Accordingly, the transition period of 3 years is coming to an end in the spring next year. The new Medical Device Regulation (MDR) will replace the Directive 90/385/EEC concerning active implantable medical devices and the Directive 93/42/EEC concerning medical devices (referred to as Medical Device Directive, MDD).
During the transition period the MDR will enter into force gradually. In the first phase, manufacturers can apply new certificates under the MDR and the Notified Bodies can apply re-designation. After the transition period the MDR will be fully applied.
Devices CE marked under the MDD may still be placed on the market after 27 May 2020 if the certificate is valid. I.e. the certificates issued before 26 May 2017 as well as the certificates issued between 26 May 2017 and 26 May 2020 will remain valid until 27 May 2024 or until the end of the period (max 5 years) indicated on the certificate issued by the Notified Body. This additional period allows the manufacturers to sell out the remaining stocks of devices that were legally placed on the market before the date of application. However, it should be noted that major design or production changes cannot be made for the device. After 26 May 2025 only devices complying with the MDR can be placed on the market.
The key reforms related to the MDR:
- The classification of several old products will change to a higher class, which requires conformity assessment by a Notified Body and results in an increased number of requirements for the manufacturer. Also, the MDR covers now internet sales of medical devices offered at distance, certain devices with no intended medical purpose, all devices for cleaning, sterilising or disinfecting other medical devices and reprocessed single-use medical devices.
- The manufacturers have to designate a competent person responsible for regulatory compliance.
- There are clearly specified general obligations for economic operators (manufacturers, importers, distributors) and authorised representatives.
- Greater emphasis is now put on the safety life-cycle of a product, and it`s backed up by clinical data.
- The role of the risk management and especially benefit-risk analysis becomes more and more important. In practice, the manufacturers should have a risk management process in addition to the quality management and post-market surveillance systems.
- The nature of clinical evaluation and post-market surveillance as an on-going process throughout the device life cycle is emphasised which creates a need for new clinical and post-market phase documentation. In addition, a clinical evaluation consultation procedure for certain class IIb and for implantable class III devices by an independent expert panel is introduced in the MDR.
- Unique Device Identifier (UDI) system is created to allow the identification of the device, to facilitate the traceability of devices and significantly enhance the effectiveness of the activities related to post-market
- European database for medical devices (Eudamed), a web-based portal acting as a central repository for information exchange, is build up and maintained by the European Commission. The aim is to increase the quantity and quality of data and to enhance transparency by providing publicly available information about the devices and studies.
- Stringent requirements for the designation of notified bodies, with increased control and monitoring by the national competent authorities and the Commission.
Be prepared for the new requirements before the MDR takes effect! Medfiles has the experience and vision required to make your products and quality management system MDR compliant on time.
We offer comprehensive expert services covering the entire product life-cycle of medical devices and in vitro diagnostic devices and help you with tasks related to the quality management system.
If you need assistance in adapting to the MDR or IVDR, please contact our Regulatory Affairs Manager, Päivi Turta.