Euro Roundup: MedTech Europe report cites admin burdens under IVDR, MDR amid flurry of activity
MedTech Europe has published a 100-page report on the administrative burdens imposed by the new medtech regulations. The trade group published the report amid a flurry of papers setting out its views on various topics.The administrative burden report is part of MedTech Europe’s response to the European Commission’s call for feedback on the rules on devices and in vitro diagnostics (IVDs). With the consultation ending this week, the trade group has told the Commission what it sees as the main areas where the regulations impose burdens “that are unnecessary or inefficient in achieving compliance” and proposed solutions.
“While each requirement may seem to have good reasons when seen in isolation, their layering creates an overall cumulative effect leading to inefficiencies and complexity which can be devastating especially for SMEs,” MedTech Europe said. “It should be considered which requirements really are needed.”
The report lists burdens and suggests short-, mid- and long-term fixes. For example, the trade group said authorization and notification for IVD performance studies is “burdensome, non-harmonized and costly.” In the short term, the burden could be mitigated “by ensuring that assessments and approvals are only required once for multinational studies.” Digitalization to simplify the process is the mid-term fix.
On the medical device side, the trade group named an increase in the number of post-market and clinical reports that manufacturers have to maintain as a burden. MedTech Europe has asked the Commission to “leave it at the discretion of the manufacturer to clearly identify one document as a main source for the basic information.” The recommendation is part of a set of short-term measures to address the burden.
MedTech Europe published the report alongside documents on other aspects of medtech regulations. The files cover the European Health Data Space, the EUDAMED database, the digitalization of technical documentation and the submission of vigilance reports to notified bodies.
Burden Report
EU medicines agencies publish strategy through 2028
The European Union medicines agencies network has released its strategy through 2028, setting out how officials plan to seize “opportunities in a changing medicines landscape.”
Working with the Heads of Medicines Agencies (HMA), the European Medicines Agency (EMA) created the strategy in light of feedback on a reflection paper they released for consultation last year. Industry representatives raised concerns about the regulatory network's capacity to implement the strategy, but 19 out of the 24 responses were positive. Two trade groups expressed a neutral view on the proposals.
After reviewing the feedback, EMA and HMA published a paper that will set the direction of the EU medicines agencies network for the next few years. Maria Lamas, chair of the HMA management group, said “in the face of a new global framework, it is important that the European medicines regulatory agencies contribute to EU competitiveness.” The paper represents a roadmap for achieving that goal.
EMA and HMA have grouped sets of objectives into six categories: accessibility; leveraging data, digitalization and artificial intelligence; regulatory science, innovation and competitiveness; antimicrobial resistance and other health threats; availability and supply; and sustainability of the network.
Several of the objectives could help address industry concerns about the capacity of the EU regulatory network. As part of their work on availability and supply, officials plan to reinforce the oversight and protection of the supply chain and increase inspector capacity. Sub-objectives under that goal include ensuring “sufficient numbers of trained inspectors are continuously available to perform legal duties.”
EMA and HMA’s top objective related to the sustainability of the network is to “reinforce the scientific and regulatory capacity and capability of the network.” In working to achieve that goal, officials plan to ensure the network can support innovation and the use of new methodologies, AI and data analytics and is equipped for the pharmaceutical legislation. Officials will also add digital capabilities and explore ways to improve efficiency by creating centers of excellence and allocating national resources strategically.
Industry representatives commented on AI during the consultation, telling EMA and HMA that it should be viewed as a tool to achieve the network's goals rather than as an end in itself and that transformation must directly benefit sponsors. The agencies retained the AI-related objectives they drafted for the consultation, keeping the focus on leveraging experimentation and technological advances in AI to support digital business transformation and harnessing the potential of AI throughout the lifecycle.
Most of the goals are unchanged from the reflection paper but EMA and HMA added a new point to the section on antimicrobial resistance and other health threats. The final paper includes “explore ways to better inform the public about medicines for health threats to engender trust in medicines and the regulatory system” as a sub-objective. That point was absent from the reflection paper.
EMA’s board adopted the strategy at its March meeting. The board also used the meeting to elect Rui Santos Ivo as its chair for a three-year period. Ivo, the president of the Portuguese National Authority of Medicines and Healthcare Products, is taking over from the Irish Health Products Regulatory Authority’s Lorraine Nolan when she completes her mandate as chair of the board on 21 March.
Press Release
EMA warns unregulated advanced therapy medicinal products pose serious risks to health
EMA and HMA have warned the public about the dangers of unregulated advanced therapy medicinal products (ATMPs) offered to patients in the EU.
ATMP is an umbrella term for medicinal products based on genes, tissues or cells. The agencies issued the warning after finding individuals, companies and clinics have been marketing unregulated ATMPs directly to patients. Often, there is little or no evidence that the products work or are safe, the agencies said. The unregulated products include dendritic cell therapies intended to treat cancers.
“The products are usually sold on websites or social media channels as a last hope, exploiting the worries of patients and their families. National authorities are taking action to stop the sale of such products and, in some cases, are involving the police,” EMA said. “While there is usually little or no evidence that these products are effective, they may pose the risk of severe side effects.”
Press Release
MHRA creates decentralized manufacture hub to help industry prepare for incoming rules
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has created an information hub to help the industry prepare for new rules on medicines made at or close to the point of patient care.
New regulations on such medicines will take effect on 23 July. MHRA said decentralized manufacture, a collective term for point of care and modular production, “presents some new challenges compared with traditional medicinal product manufacture.”
The agency is developing guidance to “provide clarity on regulatory expectations.” MHRA collected feedback on draft guidance at an in-person workshop this month and plans to publish the document in early summer 2025. The agency will regularly review and update the guidance, reflecting the emerging nature of decentralized manufacture.
MHRA Hub
Other News:
EMA has published its annual report on independence. The report covers the status of EMA policies on the independence of scientific committees’ members and experts and other groups. EMA described one breach of trust case in 2024 that concerned an expert who failed to declare current and past consultancy interests in pharmaceutical companies. EMA Report
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