To market a medical device in Europe, the Legal manufacturer have to comply with the European regulation in force (2017/745 for Medical Device Regulation and 2017/746 for In Vitro Medical Device Regulation (IVDR)
The European Union introduced those regulations for the regulation of medical devices and in vitro medical devices (IVDs), respectively. The Medical Device Regulation (MDR) 2017/745 and the In Vitro Medical Device Regulation (IVDR) 2017/746, are intended to improve the safety and performance of medical devices and IVDs in the EU market.
The MDR 2017/745 replaces the previous Medical Device Directive (93/42/EEC) and aims to increase the level of safety and performance of medical devices by introducing new requirements for clinical evidence, post-market surveillance, and transparency of information. The regulation also introduces a new classification system for medical devices, which aims to better align the level of regulatory oversight with the level of risk of the device.
The IVDR 2017/746, replaces the previous In Vitro Diagnostic Directive (98/79/EC) and aims to increase the safety and performance of IVDs by introducing new requirements for clinical evidence, post-market surveillance, and transparency of information. The regulation also introduces a new classification system for IVDs, which aims to better align the level of regulatory oversight with the level of risk of the device.
Both regulations aim to protect the public by increasing oversight of devices throughout their lifecycle and ensuring that they meet the highest standards of safety and performance. The new regulations however, have a significant impact on manufacturers, distributors, and notified bodies, and require them to adapt their processes and systems to comply with the new requirements.
Here are the necessary steps to take in order to be compliant with MDR/IVDR European regulation when marketing a medical device in Europe :
- Device classification: The device must be classified according to the EU MDR / IVDR , depending on the level of risk it poses.
- Technical documentation: The manufacturer must prepare a technical file that includes information such as the device’s design, performance, and instructions for use.
- Quality management system: The manufacturer must have a quality management system (QMS) in place that complies with the European regulation.
- Device registration: The device must be registered in the EUDAMED database.
- Clinical evaluation: Manufacturers of medical devices must provide a clinical evaluation report that demonstrates the clinical performance of the device.
- Notified Body assessment: The manufacturer must select a Notified Body, an organization that has been designated by the EU to assess the conformity of the device to the relevant EU regulations.
- CE Marking: Once the Notified Body has assessed the device and the manufacturer’s QMS and has issued a conformity assessment certificate, the manufacturer can affix the CE marking to the device.
- Post-market surveillance: Manufacturers must establish a post-market surveillance system to monitor the safety and performance of their devices after they have been placed on the market.
- Vigilance : Manufacturers must report any incidents or serious adverse events associated with their devices to the EU and the national competent authorities.
- The elements presented above are well detailed in the articles and annexes of the regulation, there is also several guidelines provided by the European commision to help, amongst others, the manufacturer throughout compliance process