Euro Roundup: MEP calls medtech rules a ‘bureaucratic monster’ as calls for change intensify

Members of the European Parliament have added to the calls to reform the medtech regulations, with one politician calling the current rules a “bureaucratic monster.” The European Commission, which has warned against “a rushed initiative,” also came under renewed pressure from industry to act urgently.

Olivér Várhelyi, the incoming Commissioner for Health and Animal Welfare, listed the evaluation of the need for potential legislative changes to the current framework as a priority in his “mission letter” last month. The Parliament met to discuss the Commission’s plans last week and politicians used the event to push for faster action.

Parliamentarian Peter Liese began with praise for MDR and IVDR, saying the regulations “were not only well meaning, they were urgently needed” because of the medtech scandals in the EU in the preceding years. However, Liese said the regulations have had unintended consequences.

“What we realize today is that the EU institutions have gone beyond their objective,” he said. “We have created a bureaucratic monster with loads of rules that do not increase safety, but increase costs and effort, that costs us jobs and economic growth at a time when the European economy is in a crisis situation, and it endangers human lives too.”

Liese said it is a good thing that the mission letter clearly states the problem must be dealt with but the terms are “too weak.” Parliamentarians “hear a lot more about evaluations,” Liese said, and are being told to expect action in 2026. Liese believes that is too late and told President Ursula von der Leyen that “this has to go faster, within 100 days of the start of the new Commission.”

Another politician reiterated the call for quick action, stating that it is important for the Commission to at least proposed publish revisions within 100 days. The urgency reflects the belief that MDR is restricting access to medical devices, including products to treat children.

Věra Jourová, vice-president for values and transparency at the Commission, said she understands the calls for urgent revisions to MDR. However, with the EU having already extended the transition periods, Jourová strongly cautioned against “a rushed initiative.” The EU must get the revisions right “on the basis of data and analysis, together with the necessary involvement of all the relevant stakeholders,” she said.

Stakeholders are split on how quickly the Commission should act. MedTech Europe and 39 national associations are pushing for urgent action. In an open letter to the Commissioner for Health and Food Safety, the groups said that the EU should develop a package of legislative reforms for MDR and IVDR “as an immediate outcome of the targeted evaluation running until end-2025.”

The reforms, which the groups said should focus on delivering the original objectives of MDR and IVDR, are one of three sets of actions proposed by the groups, who also want the Commission to enact “bridging measures” to support device availability and the viability of the medtech industry as urgently as possible and take steps to improve implementation of the rules.

The European Patients Forum (EPF) also published its views on how to proceed. EPF said it is “very concerned about calls for an immediate reopening of the [MDR] and fast-track amendments to the legislation within 100 days.” The concerns reflect a belief that a rushed revision would not be in the interest of patients.

Parliament Debate, Open Letter, EPF Notice

Swissmedic optimizes application process for fast-track and temporary authorizations

The Swiss Agency for Therapeutic Products (Swissmedic) has “optimized” the process for applying for the implementation of a fast-track or temporary authorization.

The changes affect what happens when the criteria for the authorizations “cannot be conclusively evaluated following the assessment of the submitted documents by Swissmedic,” the regulator said. In that situation, an accelerated application hearing (AAA) usually takes place.

Under the new process, Swissmedic can skip the hearing “if the additional documents submitted by the applicant for the scheduled AAA show that all of the criteria for the requested authorization procedure are fulfilled.” If so, the agency will approve the request for a fast-track or temporary authorization without holding the hearing.

Swissmedic has also clarified the submission date for the authorization application. If the procedure for the fast-track or temporary implementation is approved, “the applicant can submit the authorization application on the date stated on the decision minutes,” the agency said. Applicants can contact Swissmedic to check if it will be possible to file on an earlier date.

Swissmedic Notice

Frequency of UK health tech regulatory capacity challenges doubles in one year, survey finds

The number of health technology companies reporting regulatory capacity challenges has doubled since last year, an industry survey found.

In recent years, annual surveys by the Association of British HealthTech Industries (ABHI) and Centre for Process Innovation (CPI) have shown how post-Brexit regulatory uncertainty has affected investment in the UK. The 2024 survey found 50% of respondents expect regulatory uncertainty to delay the introduction of their innovative medical products in the UK.

The figure is down from 2022 and 2023, when more than 60% of respondents said the same; however, in other areas, the situation is getting worse. Twice as many companies reported capacity challenges in 2024 compared to last year. The top suggestions for addressing the problem were increases in the number or capacity of approved bodies and a greater focus on hitting timelines and cost targets.

Regulatory costs are potentially an emerging concern. Almost one in 10 companies said their regulatory costs have risen by more than 50%. Many other companies reported that their costs had gone up 10%-49%. The results contributed to the finding that regulation was the fourth most common area of cost rises after freight services, labor and sustainability requirements.

ABHI and CPI noted that companies are experiencing steep rises in regulatory costs at a time when the UK Medicines and Healthcare products Regulatory Agency (MHRA) has proposed further fee increases. MHRA is seeking feedback on its proposals until next week.

Press Release

EMA seeks feedback on revised rules for handling competing interests of experts

The European Medicines Agency (EMA) is running a consultation into revised rules on handling the competing interests of committee members and experts.

In March, the European Court of Justice ruled that applying EMA rules on competing interests “could be incompatible with the principle of objective impartiality” in specific circumstances. Ruling on a case brought by cancer drug developer PharmaMar, the court concluded the rules could “give rise to a legitimate doubt as to the existence of possible bias.”

The revised rules reflect that ruling and another judgment. Responding to the rulings, EMA is proposing to increase and align “restrictions across roles and groups for experts with a current interest in a product.” The change will add new situations in which experts may be excluded from procedures. Other changes affect competing interests in the medical device industry.

EMA is seeking feedback on the revised rules until 10 November.

Press Release

Euro Roundup: MEP calls medtech rules a ‘bureaucratic monster’ as calls for change intensify

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