MEDICAL DEVICE DIRECTIVE EU 2017/745 (MDR).
On 5/5/2017, two new laws on medical devices were approved by the European Commission, Medical Device Regulation 2017/745 (abbreviated: MDR) and In-vitro Diagnostic Regulation 2017/746 ( abbreviation: IVDR).
On 5/5/2017, two new laws on medical devices were passed by the European Commission, Medical Device Regulation 2017/745 (abbreviated: MDR) and In-vitro Diagnostic Regulation 2017/746 ( abbreviation: IVDR). These two laws were officially put into effect on May 25, 2017. Medical device manufacturers will have 3 years to transition from MDD 93/42/EEC (Medical Device Directives) or AIMDD 90/385/EEC (Active Implantable Medical Device Directive) to MDR 2017/745 (the deadline) May 26, 2020) and 5 years to convert from IVD to IVDR (the deadline is May 26, 2022). After this date, organizations that want to get CE marking certification for medical devices are required to certify under MDR/IVDR but cannot apply MDD/AIMDD/IVD anymore.
See “CE marking process for medical devices according to Medical Device Regulation 2017/745”.
Updated according to the latest announcement, the mandatory deadline for converting to MDR 2017/745 will be 1 year behind schedule (ie, May 26, 2021).
What is the difference between Medical Device Directive (MDD) and Medical Device Regulation (MDR).
* Medical Device Directive (MDD) sets out requirements that EU member states must meet. Each member state can make its own regulations, but must meet the requirements set out in the Directives.
* Medical Device Regulation (MDR), which can be roughly understood as one level above the MDD, the MDR is applied directly and consistently to all EU member states.
The Medical Device Regulation 2017/745 (MDR) includes the following main sections:
MDR 2017/745 has a total of 10 chapters with 123 articles, 17 appendices. (while MDD 93/42/EEC has 23 articles and 12 annexes). Essentially, the contents of MDR 2017/745 are still the same as the requirements of MDD 93/42/EEC or 90/385/EEC, but with some important updates:
* New European compliance expert body: Establishing a medical device Coordination Group (MDCG). The agency consists of 11 groups: Notified Bodies Oversight; Standards; Clinical Investigation & Evaluation (CIE); Post-Market Surveillance & Vigilance (PMSV); Market Surveillance; Borderline & Classification (B&C); New Technologies; European Database for Medical Devices (Eudamed); Unique Device Identification (UDI); International Matters; In Vitro diagnostic medical devices (IVD).
* General Safety and Performance Requirements (GSPR). In MDD/AIMDD, it's called essential requirements. However, MDR 2017/745 does not use this concept anymore, but uses GSPR. When it comes to GSPR, the default is MDR and not MDD/AIMDD.
* Notified bodies: The most important change is the mandatory application of Unannounced Audit.
* Clinical Evidence: Requirements for the disclosure of product safety and performance data, and post-market clinical follow up.
* Post market surveillance and vigilance: EU implements EUDAMED data system. All data in this section must be uploaded to EUDAMED.
* Transparency and traceability: Implement and apply UDI (Unique Device Identification). This is a new requirement in Europe, while UDI has been required by the FDA for quite some time.
* Medical device classification: add some rules when classifying medical devices.
------*****------
