Euro Roundup: Commission consults on changes to MDR, IVDR

The European Commission has published a call for evidence on the medical device and in vitro diagnostic regulations (MDR/IVDR).

Late last year, the Commission ran a targeted evaluation of the contentious regulations. Officials said the goal of that consultation was to identify problems in the legal framework. The new call for evidence aims to “gather input to address the identified problems in a targeted way,” the Commission said. Officials provided a high-level look at their goals for the planned solutions.

“The initiative aims to simplify and streamline the regulatory framework, and make it more cost-efficient and proportionate, while preserving a high level of public health and patient safety and maintaining the overall structure of the current regulatory framework,” the Commission said.

Specific objectives include cutting the administrative burden including reporting obligations and making the certification process more predictable and cost-efficient. The Commission also wants to establish more proportionate conformity assessment requirements, especially for low- and medium-risk devices and products that cater to special patient needs.

Other specific objectives include enabling the European Union medical device sector to benefit from international cooperation including reliance and better aligning the regulatory framework with other relevant legislation. The list of aims aligns with feedback provided by industry groups, such as warnings about the risk of overlaps between MDR and IVDR and pan-industry laws including the AI Act.

The Commission is seeking feedback on the objectives and likely cost savings of the proposed targeted revision. Officials are putting a particular focus on the views of small- and medium-sized enterprises, which can be disproportionately affected by regulatory burdens. The feedback will inform the creation of a targeted revision and be reflected in the Commission staff working document.

Officials are accepting evidence until 6 October.

Commission Consultation

MHRA shares guidance on what details to include in postmarket surveillance reports

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance to help medtech companies submit standardized postmarket surveillance reports (PMSRs).

Officials recently added postmarket surveillance requirements to the UK Medical Devices Regulations. The revised regulations require manufacturers to prepare a PMSR within three years of a device coming to market or of the updated rules coming into force. Companies need to update the report at least every three years.

To help manufacturers comply with the requirement, MHRA has published a standardized format for PMSRs and explained what information companies should include. Companies only need to fill in the sections that apply to their devices and can display data in an alternative form if appropriate. MHRA has asked companies that deviate from the standardized format to justify the change in the PMSR.

Standardized PMSRs start with a cover page, executive summary and description of the devices covered by the report. A section on device performance information forms the centerpiece of the reports. In that section, MHRA wants companies to present details of serious incidents, field safety corrective actions and any other information that is relevant to postmarket surveillance of the devices.

The final two parts of the reports cover preventive and corrective actions and findings and conclusions. MHRA wants manufacturers to assess the validity of the data, present their overall conclusions and set out what actions they are taking to address the findings.

“If there has been a negative impact on the overall benefit-risk determination, the manufacturer should outline all actions planned or already undertaken to mitigate this risk,” MHRA said. “In the case of system or procedure packs, the focus should be on analyzing PMS information relating to the safety and performance of the combined use of the devices in the pack.”

MHRA Guidance

Drive to create favorable regulations for reshoring receives environmental pushback

A debate at a European Parliament committee has revealed a tension between a push to encourage the reshoring of pharmaceutical manufacturing and a desire to protect the environment.

The debate happened when the Committee on the Environment, Climate and Food Safety met to discuss the proposed Critical Medicines Act. Aurelijus Veryga, a Lithuanian politician, said human health should be the priority, arguing that politicians “cannot expect the production to return to Europe if we're going to impose additional burdens on our producers.”

Veryga’s position is that the European Union has “to protect the environment but not at the expense of human health.” The politician named the Urban Wastewater Treatment Directive as an example of an EU law that, in his view, had negative effects on humans.

Tilly Metz, a Luxembourgish politician, took the other side of the debate, warning that attempts to bring production back to the EU “cannot become a backdoor to bypass environmental protections.” German politician Tiemo Wölken made a similar point when he said the law “must not be used as a pretext to weaken or bypass existing environmental rules.”

The debate will inform proposed amendments to the European Commission’s proposal. Representing the Commission at the meeting, Bruno Gautrais said the goal is to maintain environmental standards while keeping health at the heart of the proposal.

“This is more about streamlining, facilitating the administrative work linked to repatriating production than lowering standards,” Gautrais said. “Nevertheless, we hear the call for streamlining the various legislation, for making it easier and quicker to get the necessary permits. I think that’s also part of the intention of the proposal.”

Meeting Recording

Commission answers questions about the Health Technology Assessment Regulation

The European Commission has published a frequently asked question (FAQ) document about the Health Technology Assessment Regulation (HTAR), which has been in effect since January.

To support the implementation, the Commission has shared preliminary views on the legislation in the FAQ. Officials said the views expressed in the FAQ “may not under any circumstances be regarded as stating an official position of the [Commission].” The questions are based on inquiries and will be updated regularly, the Commission said.

The Commission has used the FAQ to explain what products are subject to joint clinical assessments (JCAs) and the timing of the stepwise approach to implementation. The document features sections about which drugs are subject to JCAs in 2025 and 2028, the two key years in the stepwise approach to the full rollout scheduled for 2030.

Other sections cover how HTAR will affect variations to existing approvals, conditional marketing authorizations and diagnostic products.

Commission FAQ

MHRA seeks feedback on prioritization of designated standards for devices and IVDs

MHRA is seeking feedback on the prioritization for designation of device standards that support compliance with the UK medtech regulations.

UK regulatory bodies officially recognize designated standards. Compliance with the standards provides a presumption of conformity with the essential requirements of relevant regulations.

MHRA is seeking feedback on the designated standards that organizations currently use and on whether there are standards that companies would like to see designated. Officials also want to know whether any existing designated standards should be removed or replaced.

Another section of the consultation asks whether designated standards save time in the submission and approval process and are helpful for business compliance and efficiency.

MHRA is accepting feedback until 30 September.

MHRA Consultation

Other News:

EMA’s management board has unanimously approved the renewal of Emer Cooke’s mandate. The renewal extends Cooke’s tenure as the agency’s executive director until 30 April 2027. EMA Notice

Euro Roundup: Commission consults on changes to MDR, IVDR

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