The Regulation (EU) 2017/745 on medical devices (MDR) was created with the aim of increasing patient safety by introducing rigorous testing procedures. Those procedures are intended to prevent unsafe or non-compliant devices from being placed on the market and emphasized the supervision of the devices when they are placed on the market.
This also has an effect on clinical investigations. In the MDR, the rules for clinical investigations are distinguished between different categories of investigations:
- Clinical investigations carried out in the context of product development (Article 62, par. 1 and Article 74, par. 2 MDR) in which a distinction is made between:
- Class I and non-invasive Class IIa and IIb medical devices.
- Invasive Class IIa and IIb medical devices and Class III medical devices.
Post-market clinical follow-up investigation
- Clinical investigations with a CE-marked medical device as part of the post-market follow-up in which participants are required to undergo additional invasive or burdensome procedures (Article 74, par. 1 MDR).
- Clinical investigations that do not fall under the two categories above (Article 82, par. 1 MDR).
The regulatory pathway a sponsor shall follow is based on the purpose of the clinical investigation. The regulatory pathway chosen depends on the clinical development plan, and the proposed use of the clinical data.
According to the MDR, the documents listed in Annex XV must be submitted in the electronic system for clinical investigations within EUDAMED, when the system is up and running, the information is potentially publicly accessible via EUDAMED. Until the EUDAMED database is ready, all requested information to apply for or notify a clinical investigation should be submitted to the national competent authorities unless otherwise specified in the member state concerned. Additionally, each country will still be using their own systems until the EUDAMED database is available and ready for use.
MedQ Consultants B.V. has supported various sponsors throughout their MDR clinical investigation applications in various member states and will continue to do so.
For more information or to get in touch with one of our specialists, please do not hesitate to contact us.
MedQ Consultants B.V.