The adoption of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices (IVDR) changes the way medical devices will be regulated going forward. Medical devices are products or equipment intended generally for a medical use. They are regulated by National Competent Authorities (NCAs), but the European Medicines Agency (EMA) is also involved in the assessment of certain categories of medical device under EU legislation. The intent of these new regulations is to improve the quality, safety and reliability of medical devices, while strengthening the transparency of information for consumers, and enhancing vigilance and market surveillance.
There are a significant number of changes impacting both the regulators as well as current suppliers of medical devices and suppliers who previously did not fall under these regulations. The definition of ‘medical devices’ and ‘in vitro diagnostic medical devices’ has been broadened, impacting a much larger set of products and companies. This means that companies who were previously unregulated will now face the significant challenge of preparing for these regulatory requirements. Agencies are also impacted, as they will be introducing new roles and responsibilities for EMA and NCAs in relation to certain types of medical devices and in-vitro diagnostics.
These Regulation were adopted by the European Parliament in April 2017 and entered into force on 25 May 2017. Businesses are expected to comply in full with the medical device regulations by 26 May 2020 and with the in vitro devices regulation by 26 May 2022.
Please refer to the following for additional information:
- EMA – Human Regulatory – Overview: https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- Regulation (EU) 2017/745 on Medical Devices (MDR)
- Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices (IVDR)