Main changes of the new Regulations on Medical Devices (MDR 745/2017) and on in vitro diagnostic medical devices (IVDR 746/2017)
The new Medical Devices Regulations introduce changes and news compared to the current European directives for medical devices and in-vitro diagnostic medical devices.
Major changes in the new Medical Devices Regulations:
- Increased clinical evidence: the collection and evaluation of clinical data will become part of SGQ and each device must undergo a continuous improvement cycle. Data from equivalent devices is accepted, but more restrictive criteria have been introduced to demonstrate equivalence. Accordingly, most of clinical data should be obtained from clinical trials, in particular for Class III and implantable devices.
- Vigilance and post-market surveillance more stringent: the clinical evaluation and vigilance reporting are now integrated in the requirements of the Regulation to facilitate the execution, while in the precedent Directives were described only in the attachments. Furthermore, greater authority will be provided to the competent bodies in the post-market surveillance. Manufactures of Class IIa, IIb and III medical devices will be required to prepare a Periodic Safety Update Report (PSUR).
- Identification of at least one person responsible for regulatory compliance: Manufacturers and Authorized representatives should have available at least one person responsible for regulatory compliance who ensures that the device complies with all the requirements of the New Regulations. The qualifications of the person responsible for regulatory compliance are defined within the Regulations.
- Traceability: the Regulations establish a new system of Unique Device Identification (UDI), which has been introduced to facilitate the traceability of devices. Through the UDI code it will be possible to access device information in EUDAMED, which is a new European database for all Member States and accessible to the public.
- Extension of the scope: the definition of a medical device has been expanded, so that products that are not intended for medical use, such as colored contact lenses or equipment for aesthetic treatments, fall within the scope of application,. New classification system for IVD: Four classes of risk for IVDs were introduced, from class A to D, and specific classification rules were defined.