Euro Roundup: MedTech Europe calls for ‘comprehensive structural reform’ of MDR, IVDR

MedTech Europe and 34 national associations have asked the European Union (EU) Commissioner for Health to implement comprehensive structural reforms to address challenges created by the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

In an open letter to Stella Kyriakides, the trade groups argued that the regulations have failed to achieve their original goal of providing “a robust, transparent, predictable and sustainable regulatory framework that ensures a high level of safety and health while supporting innovation.” As MedTech Europe sees the situation, the EU is yet to fully achieve that goal after more than six years of implementation.

“Medical technologies – both those already on the market and future innovations − struggle to reach European patients and health systems. When medical technology innovations that are available in other regions are not available in Europe, patients will pay the highest price,” the trade groups wrote, adding that there is “a broad consensus” that the regulations are affecting the availability of existing products.

The perceived failure of the MDR and IVDR to achieve their goals, despite years of work, informs the trade groups’ view that “there are structural issues in the regulatory framework which cannot be solved simply through its implementation.”

Faced with a framework that they call “unpredictable, complex, slow and costly,” MedTech Europe and its co-signatories are pushing for comprehensive changes to MDR and IVDR. The trade groups are calling for three main reforms: a more efficient and fit-for-purpose CE marking system; a system that supports medtech innovation; and a single structure that oversees and manages the regulatory system. MedTech Europe briefly set out its thinking on each of the reforms in the letter to Kyriakides.

The trade groups want a CE marking system that takes “the best of the current framework” but improves resource efficiency for manufacturers, notified bodies and authorities and makes conformity assessment more predictable. Specific proposals include removing the limited validity of certificates and bringing the EU into the Medical Device Single Audit Program. The trade groups say the changes will reduce administrative burdens and costs.

For the innovation reform, MedTech Europe wants the EU to incorporate “an explicit innovation principle aimed at swiftly connecting the latest medical technologies to European patients and health systems.” The trade groups identified “well-resourced platforms for early dialogue with developers on evidence expectations” and “dedicated and fast-track assessment pathways” for medical technologies as ways the EU can meet its request.

The third proposal is intended to “put all this into practice” by creating “a single, dedicated accountable structure to oversee and manage the regulatory system.” MedTech Europe envisages the new structure designating and overseeing notified bodies and being “empowered to take system-level decisions to ensure efficiency and agility,” such as the implementation of accelerated pathways.

“We ask that you formally elevate the need for comprehensive structural reform within Europe’s health policy debates,” the trade groups wrote. “Existing fora, such as the Heads of Medicines Agencies, the [Medical Device Coordination Group], Study on Governance & Innovation and other areas, should be fully leveraged to bring together all medical technology stakeholders to jointly craft solutions, with clear actions and milestones mapped out to ensure these solutions are enacted as swiftly as possible.”

Press release, Open letter

MHRA shares guidance on Innovative Devices Access Pathway as pilot phase gets underway

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on a new pathway designed to accelerate access to innovative medical technologies.

First announced in May 2023, the Innovative Devices Access Pathway (IDAP) offers support and benefits, such as system navigation advice, priority clinical investigation, help with health technology assessment adoption and exceptional use authorization if safety standards are met. MHRA is working with bodies, including the National Institute for Health and Care Excellence (NICE) to deliver the program.

“This pathway will offer companies the direction they need to properly demonstrate the value of innovations that have the potential to address unmet need in the system,” said Jeanette Kusel, director of NICE scientific advice.

The program is open to medical technologies that address significant unmet needs and are yet to receive regulatory approval or clearance, such as a CE mark. Applicants, which can be based in the UK or overseas, must provide proof-of-concept data on a near-final prototype and have already sought clinical input from at least one UK health organization or medical charity.

Applicants can access more information in three guidance documents that MHRA released in conjunction with the start of the pilot project. The documents discuss the pilot phase, the application process and opportunities for patients and the public to get involved in the initiative.

MHRA is accepting applications to join the IDAP pilot until 29 October.

Press release, MHRA guidance

EMA answers 14 questions on biological medicinal products

The European Medicines Agency (EMA) has published a question-and-answer document on biological medicinal products.

EMA’s Biologics Working Party created the document to state its position on “issues that can be subject to different interpretation or require clarification, typically arising from discussions or correspondence during assessment procedures of biological human medicinal products.” That goal has led EMA to answer 14 questions on topics such as process validation, biosimilars and polysorbate testing.

In its responses, EMA clarifies that “it is acceptable not to routinely test for process related impurities if consistent elimination has been demonstrated by validation studies” and that “characterization results of the reference product ... may be used for clinical justification of the specification limits” of a biosimilar.

Another question covers testing for polysorbate, an excipient commonly used in biologics that can break down and cause particle formulation. EMA wants manufacturers to include a test for polysorbate “not only in the routine release but also in the stability specifications” if degradation is a risk. Alternatively, a manufacturer could provide evidence that polysorbate levels remain stable over the proposed shelf life.

EMA Q&A

European Commission carries out unannounced antitrust inspections of medical device firm

The European Commission has carried out unannounced inspections of a medical device company active in cardiovascular health after becoming concerned the business may have violated antitrust rules.

According to the Commission, the unnamed company “may have violated EU antitrust rules that prohibit abuses of a dominant market position.” The concerns led the Commission and a national competition authority to perform an unannounced inspection of the company.

Unannounced competition inspections are preliminary investigative steps that enable the Commission to gather evidence when a company is suspected of engaging in anti-competitive practices. The company has not been found guilty and the investigation does not prejudge the outcome of the investigation. It is unclear when the Commission will complete its investigation and there is no legal deadline.

Press release

Other News:

Ireland’s Health Products Regulatory Authority (HPRA) has updated its guide for national scientific and regulatory advice. The document, which HPRA said has been “substantially updated,” describes the types of advice that are available, how to make a request for advice, the documents to provide, what happens at the meeting and the fees that are involved.

HPRA notice, Updated guide

Medicines for Europe has praised a proposal to ensure a planned European wastewater directive does not jeopardize the affordability, accessibility and availability of generic drugs. The European Parliament’s environment, public health and food safety committee voted in favor of the proposal.

Press release

Euro Roundup: MedTech Europe calls for ‘comprehensive structural reform’ of MDR, IVDR

Related topics

Recommended content

Welcome to the new RAPS Digital Experience