At Bevinced-Legal, we specialize in serving as your Legal Representative for Clinical Investigation of medical devices within the European Union. Our expertise ensures that your Clinical Investigations and performance evaluations comply with the aspects of the Medical Device Regulation (MDR) 2017/745, pertaining to the requirements of Articles 62(2) and 82(1), as well as In-Vitro Diagnostic Regulation (IVDR) 2017/746 article 58(4).
With Bevinced-Legal, you gain a partner who not only understands the detailed requirements of the MDR’s and IVDR’s Legal Representative but also values the importance of patient safety and data integrity.
Our experienced team ensures that your Clinical Investigations (MDR) and performance evaluations (IVDR) proceed without regulatory hindrances, allowing you to focus on the advancement and innovation of your medical devices and in-vitro diagnostics.
Sponsor Representation: We can act as your designated Legal Representative if you are a non-EU manufacturer, ensuring that your Clinical Investigation or performance evaluation is in compliance with EU regulations.
Compliance Management: As your Legal Representative, we ensure that your Clinical Investigations and performance evaluations meet all regulatory requirements set out in the MDR and IVDR.
Besides BeVinced Legal we offer Clinical services as a niche Clinical Research Organization (CRO) specializing in medical device clinical trials. We have a history dating back to 1988.
In addition to our Legal Representative capabilities, we offer expertise in clinical investigations, including first-in-man studies and post-market follow-up data collection. We also assist clients with developing Clinical Evaluation Plans and Reports to ensure compliance with MDR requirements. Our consultancy services encompass Quality Management System implementation, personnel training, and regulatory guidance, helping our clients navigate complex regulations.
Together, we strive to enhance product development and support our clients in achieving their goals.
To learn more about how Bevinced-Legal can assist you with your Clinical Investigations under MDR Article 62(2) and Article 82(1), as well as In-Vitro Diagnostic Regulation (IVDR) 2017/746 article 58(4), please contact us.
Leverage our expertise to navigate the complexities of medical device and in-vitro diagnostic regulations and ensure your Clinical Investigations and performance evaluations are conducted, speedy, efficiently and compliantly.