Devicemakers planning to market products in the European Union need to understand new EU rules that spell out when clinical research is required and impose requirements for conducting trials.
The clinical research provisions of the EU Medical Device Regulation (MDR) will take effect in May 2020 and will require devices that are Class III or implanted in a patient’s body to be proven safe and effective in a clinical trial.
The MDR is more complex than the Medical Device Directives (MDD) previously in effect in the EU, says device quality systems expert Dan O’Leary of Ombu Enterprises. The process for applying to conduct a trial also will be more involved, he says.
The first step is to determine whether the device falls under one of several exceptions to the clinical investigation requirement, including devices that are a modification of a device already marketed by the same manufacturer that has been demonstrated to be equivalent to the original.
Clinical equivalence also can exempt a device from the trial obligation if it is used for the same clinical condition or purpose — including severity and stage of disease — at the same site in the body and in a similar population based on age, anatomy or physiology.
The MDR alters some of the components of a trial application. For example, the investigator’s brochure must include risk management information on devices employing a medicinal substance, human tissue or animal tissue.
The sponsor also must provide a detailed description of the specific medical or surgical procedures involved in using the device. Here they are looking for any deviation from normal clinical practice, O’Leary says.
“Where they are different, the MDR wins,” O’Leary says.
An additional element of the informed consent process under MDR requires sponsors to explain to the patient possible treatment alternatives, including follow-up measures if participation is discontinued.
Although devicemakers currently approved to conduct a trial under MDD will be grandfathered in under the MDR, O’Leary warns sponsors to stay on top of the changes. Even grandfathered trials should make sure all their documentation lines up with the new requirements, he says. “So that even though you started under the MDD, … you have the MDR requirements for the design dossier content covered, because you don’t want to get surprised at the end.” — Colin Stoecker