A new draft legislative report issued by a member of the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI), Peter Liese, would make significant changes to the manner in which in vitro diagnostic products are regulated in the EU.
The proposal follows a landmark proposal issued on 15 April 2013 by another ENVI member, Dagmar Roth-Behrendt, which called for medical devices marketed in the EU to be subject to a premarket assessment system in which high-risk devices would need to undergo a full review, while devices of lesser risk would undergo an expedited assessment procedure overseen by notified bodies.
Through IVDs are technically a subset of medical devices, they differ in that their reagents and assays are most often chemically or biologically based, and are rarely in direct contact with a human subject, vastly minimizing the risk they pose.
Liese's proposal makes a number of proposed changes to the way in which IVDs are regulated in the EU relative to a proposal put forth by the European Commission (EC).
For example, the proposal would allow Member States of the EU to "decide whether to restrict the use of any specific type of IVD device in relation to aspects that are not covered" by existing regulation. The wording of that change is taken from the advanced therapy products regulation, Liese noted in his report.
"It is a long-standing policy of the EU that the question if to allow, prohibit or allow within limits of sensible ethical technologies such as pre-implantation genetic testing is subject to the principle of subsidiarity," he explained. "Member States that allow these kinds of tests should make sure that they comply with the standards of this regulation but member states that want to prohibit it according to the national ethical debate should continue to have this possibility."
IVD testing would also be subject to an assessment by an ethics committee, with Liese saying that "the role of the ethics committee needs to be strengthened."
"Compared to the proposal on clinical trials for medicinal products, the provisions on interventional clinical performance studies are very weak and imprecise," Liese continued. "Interventional clinical performance studies may include a very significant risk for the patient, for example if the specimen is collected by spinal tap. Therefore the provisions need to be specified."
Those new requirements will be closely modeled off of existing device ethics standards, including the principles of informed consent and protection of special populations such as children and the intellectually disabled. The proposal would also allow for inspections of clinical trials.
The proposal's impact is being met with considerably less consternation than Roth-Behrendt's proposal. "This proposal is much more balanced and thought out than the general medical devices proposal," wrote Erik Vollebregt, a founding partner at Axon Lawyers, an EU medical device legal firm. "I think it the care that the rapporteur took to keep the proposal SME friendly is to be applauded."
Genetic Testing and Other Measures
However, Vollebregt also took issue with the provisions "preoccupation with any and all genetic testing," which he called "overly burdensome."
In particular, the proposal would ban any genetic test from being used by a non-medical professional, citing concerns that improper handling of the tests and notification of the results could lead to consumers being misled or otherwise harmed.
The act would allow for a transition period before the requirements come into effect, which would be longer for small and medium-sized enterprises (SMEs). Liese did note his concerns regarding the availability of enough notified bodies to carry out the proposal, explaining that designations of testing authority would need to be done as quickly as possible to ensure that IVDs don't experience shortages.
The full proposal may be found here.