The following is a partial list of the expected challenges during the transition from MDD/AIMDD to the new MDR:
More rigorous clinical compliance & documentation:
A clinical investigation is required for new MDR approvals.
Clinical evaluation – For legacy devices (CE-approved before May 26th, 2021) – A clinical Evaluation as per Article 61 & Annex XIV, alongside a comparison to another MDR-approved device, would suffice.
Stricter requirements now enforce clinical evidence to be up-to-date, unambiguous, clear and thorough. They should also be publicly available (EUDAMED).
Product classification rules and definitions of implantable devices were significantly updated – which caused a classification change for some of these devices (and devices that depend on them).
PMS (Post-Market Surveillance): he PMS requirements were made more rigorous, which affected the strictness of the GSPR. In addition, the PMS was also extended to include new MDR procedures such as PMCF and PSUR, in aim to ensure the manufacturers’ ongoing regulatory compliance.
PMCF (Post-Market Clinical Follow-up): Manufacturers are now required to gather additional clinical data on their devices after they have been placed on the market.
PSUR (Periodic Safety Update Report): A periodic report is now required for Class IIa, IIb implantable medical devices and Class III devices –. Based on the PMCF’s findings, clinical evaluations should be done and updated once a year (for class IIb and III) or every 2 years (for class IIa).
GSPR (General Safety and Performance Requirements): A set of requirements that all medical devices must comply with, in order to prove their safety and efficacy. The MDR requirements are more precise, with more requirements from manufacturers.
PRRC (Person Responsible for Regulatory Compliance): It is now required to appoint a person that will be responsible for regulatory compliance. That person should be one who possesses the requisite expertise in the field of medical devices, which shall be demonstrated by either a relevant diploma or a 4-years of experience with regulations for medical devices.
Traceability and Transparency: Stricter regulations are now in place to improve traceability and information exchange. The definitions of Economic Operators are made clearer, while additional documentation is required to be available in the EUDAMED database they use. Also, the application of UDI was significantly extended to be able to uphold better traceability standards. As part of that goal, the UDI now must also be included in the EUDAMED database.
Comprised of Basic UDI-DI and UDI-PI. The Basic UDI-DI identifies the device and is key for its traceability. Stricter rules apply to better define manufacturing procedures that are crucial for monitoring, such as labeling, packaging etc.
EUDAMED database and Economic Operators: Requirements related to the EUDAMED database were adjusted in an attempt to enhance transparency and improve the information exchange between Economic Operators, such as manufacturers, authorities, Notified Bodies, etc. As part of that attempt – it is now required to make this database publicly available.
Declaration of Conformity (DOC): Multiple instructions were updated and added to require more extensive data about the device, with clear intent to enhance its safety. Also – the manufacturers are now obligated to clearly state that the device conforms to the regulations and that a conformity assessment was carried out.
SSCP (Summary of Safety and Clinical Performance): Filing SSCP report is now required and standardized to summarize the device’s Safety Profile and Clinical Evaluations when applying for a conformity assessment.
