NEW YORK (360Dx) – The agency responsible for regulating medical devices in the UK has opened a consultation service for institutions offering laboratory-developed tests under the new European directive on in vitro diagnostics.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has also published a 22-page draft guidance for institutions that offer such tests so that they can become compliant with the new directive before the official period for bringing tests into line with the regulations ends in May 2022.
Stephen Lee, a senior policy manager at MHRA, said that the new consultation will run through March 2019 and is aimed at a "range of stakeholders, including industry, health services, professional organizations, and members of the public." It is open to entities based both in and outside of the UK, he noted.
During the consultation period, MHRA will discuss exemptions for health institutions, such as hospitals or clinical laboratories, so that they might offer tests manufactured or assembled in house without gaining formal approval, as is required for such tests under the new directive.
Lee noted that MHRA will be "actively seeking health institutions that can act as pilot sites, to start on planning and adoption of the guidance," and said the agency is already working with health institutions that have expressed interest in taking part in early adoption and pilot studies.
"The plan is for early adopters or pilots to share their experiences to help others in implementing the new requirements," Lee said.
Last year, the European Commission published new directives covering medical devices and IVDs. Under the older directive enacted in 1998, most IVDs reached the European clinical market under a self-certification process. But, under the new directive, makers of IVDs, particularly molecular tests, will now have to undergo a more stringent review process. Reviews are carried out by notified bodies (NBs), organizations within European countries that are designated for assessing products for conformity with regulations prior to gaining market entry. MHRA is one such NB.
While the UK's future relationship with Brussels is under negotiation following the country's June 2016 vote to leave the EU, it continues to observe European regulations and is now helping British stakeholders to bring their tests into compliance with the new IVD directive.
According to Lee, the new regulations maintain the exemption from the previous directive for health institutions, which MHRA defines in its draft guidance as hospitals, laboratories, local authorities, and public institutes, enabling them to offer tests manufactured or modified in house without obtaining clearance through an approval process. In the guidance, though, MHRA states that it is soliciting discussion on what kinds of other entities, such as commercial labs, might also be considered health institutions under the directive.
It also defines what kinds of tests are considered to be manufactured and modified. The latter category, introduced in the new directive, allows exempt institutions to offer tests run on platforms modified from existing devices and used in combination with other devices or equipment.
Such health institutions that wish to apply for the exemption under the new regulations must ensure that they meet general safety and performance requirements, as they did under the prior rules, Lee noted. Under the new directive, they must also demonstrate that they have an "appropriate quality system in place, a justification for applying the exemption, and technical documentation."
In terms of justification, the draft guidance states that health institutions must demonstrate that patient groups' specific needs cannot be met by an equivalent device available on the market.
Furthermore, if exempt institutions wish to partner with an external partner, such as a company, to carry out a clinical study, they might have to apply for an additional assessment by MHRA for proceeding, according to the draft guidance. MHRA states in the guidance that it is currently seeking input on how to best manage such cases.
MHRA has been working on applying the exemption in the UK by developing a "simple process" that British health institutions could use to meet those criteria, Lee noted. "We want to give health institutions as much time as possible to get to grips with the new requirements."
When MHRA published the draft guidance on Jan. 18, it stressed that it is "not complete," and it urged input from various stakeholders.
In addition to covering the changes in the new regulations, it also outlines rules governing quality management systems, inspections and enforcement, and general safety and performance requirements in line with European standards. It also calls on health institutions to have surveillance systems in place to monitor tests, and to report back adverse incidents to the agency. It further noted that services based elsewhere in Europe must follow the British requirements for maintaining compliance with the directive.
As the transition to the new regulations for IVDs is set to end in four years, Lee noted that current MHRA guidance on in-house manufacture under the older directive will apply. On its website MHRA currently offers a general guidance on manufacturing tests in house last updated in September 2014, as well as a specific guidance covering IVDs published in August 2013.