Medical Device Regulation (EU), MDR 2017/745
REGULATION (EU) 2017/745, 5 April 2017 on medical devices, MDR
In march 2010, the distribution of inappropriate silicone breast implants caused thousands of victims in France alone, and the number of potential victims was estimated as approximately 30,000. The product was certified as a medical device by a renowned Notified Body of Germany, TÜV Rheinland, and has been distributed in more than 65 countries for about 10 years.
Afterward, the ineffectiveness of Medical Device certification system under the Medical Device Directive (MDD) of the European Union became known through media coverage. In respond, European Community integrated and replaced Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMD) to Medical Device Regulation (MDR) which has legal effect directly applicable to EU member states without intermediary through implementing legislation by member states.
In May 2017, a Marseille appeal court ordered TUV to pay a total of 60 million euros – 3,000 euros to each plaintiff – in a class action case concerning 20,000 victims across 14 countries. At the time, TUV said in a statement it would make provisional payments.
First, strengthening control of high-risk devices and products that are not classified as medical devices but are subject to the MDR.
Second, improving control of in-vitro diagnostic devices (IVDs0 by amending classification rules of IVDs.
Third, faithful provision of medical device related information to consumers.
- Main content
Reinforcing risk management
- Obligation of Periodic Safety Information Update Reporting (PSUR)
- Tightened requirements for carcinogenic, mutagenic, or toxic for reproduction (CMR) substances
- Participation of expert panel in clinical evaluation review for classes IIb and III, except for certain devices
Establishment of EUDAMED
- An EU-wide database where information of manufacturer, European representative, notified body, certificate, clinical trials, post-market vigilance and post-market surveillance will be registered
More requirements on technical documentation
- Information that allow understanding of design stages applied to the device
- Complete information of manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing
- Identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities are performed
Clinical evaluation and clinical trial
- Broader range of literature review of not just on equivalent device, but also on similar devices, and/or related medical, scientific, and technology
- List of specific devices for which clinical investigation shall be conducted
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