The Medical Devices Regulation will bring massive and rapid change to the industry. Not only must companies adjust to new clinical investigation requirements, but they will suddenly find themselves in need of a number of new experts.
Medical device companies wanting to run clinical investigations of their products in Europe will need a qualified person for safety monitoring, GDPR representatives (someone to make sure that data protection is managed appropriately), an authorised representative for product quality, and a legal representative for the study.
“the use of the word “ensuring” the compliance of the sponsor places that obligation on the legal representative, and I think sponsors need to be very careful who they assign that responsibility to”
An Unfamiliar Role for Medical Devices, a very familiar one for IDEA
For most medical devices companies, the role of the legal representative is an unfamiliar one; in fact, we still encounter pharmaceutical companies that are surprised to learn they need an EU legal representative. Across the industry, there will be a lot of understandable naivety as to what the new requirements really are.
What makes this role even more challenging is that under the MDR, this individual will have the same responsibilities as the legal representative for biopharma trial sponsors. The language in MDR Article 62(2) and CTR Article 74(1) are almost identical, the only difference is the terms ‘clinical investigation’ vs ‘clinical trial’.
“[The EU] legal representative shall be responsible for ensuring compliance with the sponsor’s obligations pursuant to this Regulation” Medical Device Regulation (EU)2017/745, Art.62(2) and Clinical Trials Regulation (EU)536/2014 Art.74(1).
In particular, the use of the word “ensuring” the compliance of the sponsor places that responsibility on the legal representative, and I think sponsors need to be very careful who they assign that responsibility to.
Moreover, for clinical research organisations (CROs) that already face greater complexities with clinical investigations for devices under the MDR, taking on the responsibility of the legal representative without fully understanding the implications or the role and potential conflicts of interest poses a very tangible risk.
“IDEA Regulatory understands exactly what is at stake and how best to support sponsors with their study compliance.”
Navigating the Requirements
As a company established specifically to take on that legal representative role for clinical trials of medicines, and with many years of experience in navigating the intricacies of the requirement, IDEA Regulatory understands exactly what is at stake and how best to support sponsors with their study compliance.
We’re constantly there for clients through the duration of the trial or investigation, regularly checking what is happening, how recruitment is going, assessing potential gaps, asking about amendments or safety issues, and working to help them understand their compliance requirements in the EU.
As the legal representative, we have always followed these checks and balances combined and principles of friendly open communication. As we move to CTR and MDR implementation, “ensuring” there are no gaps or compliance issues will become even more crucial for the legal representative. For the medical device companies entering into this more tightly regulated market, understanding what is at stake is important when selecting the right providers.