The safety and clinical performance of a medical device can be demonstrated through a clinical investigation (or clinical study). From Article 62 to Article 80, the Medical Devices Regulation (MDR) sets the requirements to conduct a clinical investigation.
A clinical investigation is a systemic investigation or study which involves one or more subjects, with the aim of assessing the safety or performance of a medical device. According to Art.62.2 of the MDR, non-EU sponsors who wish to conduct a clinical investigation within the EU must appoint a Legal Representative established in the European Union.
Obelis can now act as EU Legal Representative for your
As part of our Legal Representative services, we will be able to assist you with:
- Review of Clinical Investigation Documentation to be submitted to the Competent Authorities
- Submission of the request for authorisation of a clinical investigation to the Competent Authorities concerned
- Notification of Substantial modifications to, and early termination/temporary halt of a clinical investigation to the Competent Authorities concerned
- Communication of the end of the clinical investigation to the Competent Authorities concerned
- Submission of the Clinical Investigation Report to the Competent Authorities concerned
Compliance Success Stories
“We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make is seem so easy.”
“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.”
“I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”
