Euro Roundup: Notified bodies propose steps to end ‘lengthy debates’ over MDR evidence rules

Team-NB has shared proposals for how to stop “lengthy debates” between manufacturers and notified bodies about the applicability of a rule about the need for clinical data on medical devices.

Notified body trade group Team-NB named the interpretation of the rule as one of the top issues that the European Commission should consider in its planned reforms of the regulations on medical devices and in vitro diagnostics (MDR/IVDR). MDR “creates in some cases a contradiction by requiring clinical data for all medical devices, even when such data may not be appropriate,” the trade group said.

Article 61(10) of MDR introduced an exemption from the clinical data requirements. However, Team-NB said the rule “has led to an artificial divide between devices with and without clinical data, which does not reflect real-world practice.” The trade group sees the divide as a barrier to timely assessments.

“This divide leads to lengthy debates between manufacturers and notified bodies whether Article 61.10 is applicable or not, rather than focusing on the best evidence to demonstrate safety, clinical benefit and performance,” Team-NB said. “In reality, most devices rely on a mix of clinical and non-clinical data, and the required balance varies by device.”

The trade group wants the European Union to narrow the scope of Article 61(10) and clarify its use while broadening the definition of clinical data to include real-world evidence, post-market data, and relevant international sources. Team-NB is also calling for the Medical Device Coordination Group to publish guidance that reflects a more holistic understanding of “sufficient clinical evidence.”

Notified bodies formulated the proposal as part of broader discussions about MDR and IVDR. Team-NB wants the EU to establish an early dialogue system to allow manufacturers to gain an understanding of potential gaps prior to going through complete conformity assessment. The trade group said the system could cut time to market for medical devices, provided it is set up properly.

“The system must be built pragmatically, ensuring [medical devices] still meet minimum thresholds on evidence. The proposal generated by [notified bodies] does not reduce the regulatory requirements for manufacturers but create a more open environment to discuss challenges upfront,” Team-NB said. “This extends beyond the remits of current structured dialogue, venturing into the clinical domain.”

Team-NB’s other recommendations cover the use of digital regulatory processes to increase efficiency and reduce costs, changes to the coding structure for devices and IVDs, the streamlining of the notified body designation process, and the creation of a coordinated pathway for breakthrough products.

“[Notified bodies] propose a system that involves a breakthrough designation granted by the European Commission or expert panels,” Team-NB said. “This designation would allow [notified bodies] to utilize conditional certificates with defined post-market expectations for manufacturers to gather additional evidence where required. Clear guidance and oversight of the system is essential.”

Team-NB Notice

Trade groups call for wastewater plan pause to correct ‘incomprehensible omission’

Pharmaceutical trade groups have asked the European Commission to pause the implementation of part of the Urban Wastewater Treatment Directive (UWWTD).

Under UWWTD’s extended producer responsibility scheme, the pharmaceutical and cosmetics industries will need to pay for the treatment of wastewater. The plan has received pushback from AESGP, EFPIA, and Medicines for Europe, trade groups that respectively represent over-the-counter, branded, and off-patent drugmakers. The groups accused the Commission of failing to consult drugmakers on a UWWTD study.

“This incomprehensible omission increases our deep concern about the Commission’s approach, which disregards repeated calls and recommendations from the European Parliament and the Council of the European Union to ensure a comprehensive and transparent assessment, not just an updated study,” the trade groups said.

The study is looking at the cost of implementing water treatment upgrades. AESGP, EFPIA, and Medicines for Europe are concerned that the study will fail to assess the broader consequences of the upgrades for the affected industries.

Citing the concerns, the trade groups have asked the Commission to pause implementation of its scheme and transparently consult the industries it will affect. AESGP, EFPIA, and Medicines for Europe want the Commission to conduct proper impact assessments on toxic load and implementation costs and take all actions necessary to preserve the supply of medicines.

EFPIA published a separate statement in response to comments from EurEau, a group that represents Europe’s drinking water and wastewater service operators. EurEau said pharmaceutical and cosmetic micropollutants “are a growing threat to Europe’s water” and framed UWWTD as a way to incentivize greener product design. EFPIA said EurEau could create a misleading impression of pharma’s impact.

Press Release, More

UK MHRA and NICE open aligned medicine market access pathway ahead of schedule

The UK’s regulatory and market access bodies have begun accepting submissions from drug developers for an aligned pathway six months earlier than projected.

Seeking to accelerate access to treatments, the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) have been working on a pathway to streamline the route to market. The partners are now accepting applications from manufacturers that make medicines which have been designated by NICE and MHRA for early access.

Companies that use the pathway will complete MHRA’s licensing process and NICE’s value assessments at the same time. Performing the processes in parallel will reduce the current 90-day gap between drugs winning approval and completing the value assessment process.

MHRA and NICE plan to launch a new fully integrated joint scientific advice service in April to provide a single-entry point for coordinated feedback. The agencies see the service as a way to help companies successfully adhere to aligned pathway timelines.

MHRA shared an update on the NICE collaboration shortly before disclosing the first drug candidates to receive “Innovation Passports” under the new Innovative Licensing and Access Pathway. Three potential treatments for neonatal onset ornithine transcarbamylase deficiency, Duchenne muscular dystrophy, and a rare pediatric neurodegenerative condition have received the passports.

Press Release, More

MHRA outlines actions for medtech companies to take ahead of registration fee changes

MHRA has published guidance to help manufacturers prepare for the new device registration fee that is set to apply from 1 April.

The agency received pushback on its initial proposal for the fee last year, when 72% of respondents said they did not support the plan. Needing money for its new post-market surveillance, MHRA revised the original proposal last month and set a 1 April start date for the fee.

Now, MHRA has set out the actions companies must take by March 30. The agency has asked companies to review their accounts and unregister devices that they no longer make. Companies should also register devices that they intend to place on the market. The categories of a company’s registered devices will determine what fee it pays. MHRA will not issue refunds for unregistered devices.

MHRA Guidance

Other News:

The European Medicines Agency (EMA) has updated its frequently asked questions about parallel distribution. EMA has changed its responses to multiple questions about parallel distribution procedures, what organizations should do when their details change, and the impact of the protocol on Ireland and Northern Ireland. EMA FAQ

The European Directorate for the Quality of Medicines and HealthCare (EDQM) has shared details of its approach to regulatory reliance for applications for Certificates of Suitability. EDQM Notice

Euro Roundup: Notified bodies propose steps to end ‘lengthy debates’ over MDR evidence rules

Related topics

Recommended content

Welcome to the new RAPS Digital Experience