Euro Roundup: Commission declares Eudamed modules functional, starting countdown

Editor's note: The section on pediatric investigation plans has been updated to clarify the heading and aspects of the guidance.

The European Commission has declared that four modules of the Eudamed medical device database are functional, marking the start of a six-month transition to the mandatory use of the systems.
 
In a Commission Decision published last week, officials said four modules have achieved functionality and meet the functional specifications set out in the Medical Device Regulation (MDR). The modules are for actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, and market surveillance.
 
The declaration of the functionality of the modules, which follows an independent audit report in June, starts a countdown to the mandatory use of parts of the database. Registration of new devices will move from national systems to Eudamed on 28 May 2026, six months after the modules were declared functional.
 
From that date, all new devices must be registered on Eudamed before being placed on the European Union market. The transition period, which was defined in a 2024 revision to the MDR, gives companies until 28 November 2026 to register most existing devices on Eudamed. If a device is registered before 28 May 2026, the manufacturer has until 28 November 2026 to add the product to Eudamed.
 
The longest transition period applies to the notified body module. Notified bodies have until 28 May 2027 to update Eudamed with information on MDR certificates they issued before the use of the module was mandatory.
 
Medtech companies and notified bodies already had access to three of the four newly verified modules. The actor registration module has been available for voluntary use since December 2020. Officials made the UDI and notified body modules available for voluntary use in October 2021.
 
Development of the final two modules is continuing. The Commission is aiming to put the post-market surveillance and vigilance module through an audit next year with a view to declaring it to be functional in the fourth quarter of 2026, and make use mandatory in the second quarter of 2027. The clinical investigation and performance studies module is still in development.
 
Press Release
 
UK government asks NICE to increase cost-effectiveness threshold by about 20%
 
The UK government is set to raise the midpoint of the drug cost-effectiveness threshold by 20% as part of its pharmaceutical trade deal with the US.
 
Currently, the National Institute for Health and Care Excellence (NICE) assesses if a drug is of good value for the UK health service using a standard cost-effectiveness range of £20,000 ($26,676) to £30,000 per quality-adjusted life year gained over and above current treatments. Trade group ABPI has urged NICE to raise the threshold, which has remained the same for over 20 years despite inflation.
 
Now, the UK government will ask NICE to raise the cost-effectiveness range to £25,000 to £35,000, which represents an increase of 25% at the lower end and 17% at the upper end. The change could mean more medicines meet NICE’s assessment of good value and are covered by the UK health service.
 
The international average for similar countries is around £33,400, ABPI said, meaning the UK is still in the lower half of the table. If NICE had adjusted for inflation since 1999, the UK's average threshold would be £48,300, according to the trade group.
 
Still, ABPI welcomed the US trade deal. The package of changes includes the use of a new value set for valuing health-related quality of life. The UK government said the value set, which NICE plans to introduce after a consultation, may additionally improve the cost-effectiveness of medicines on average.
 
The deal caps the repayment rate for new medicines in the Voluntary Scheme for Branded Medicines Pricing and Access (VPAG) at 15% through 2028, compared to the current rate of 23.5%. ABPI and the government plan to negotiate a new VPAG model for 2029 onward.
 
Press Release, ABPI Statement
 
EMA posts guidance on running stepwise pediatric investigation plans
 
The European Medicines Agency (EMA) has published guidance for sponsors that lack crucial information needed to define relevant parts of their pediatric investigation plans (PIPs) to complete them in a stepwise fashion.
 
EMA’s preference is to agree upfront to all measures needed to collect appropriate data for determining whether a pediatric indication for the target age range may be authorized. Yet the agency acknowledges that there may be exceptional cases where crucial information, such as whether a clinical study for a whole age group is necessary, is missing at the time of the initial PIP application.
 
In such rare cases, EMA wants to avoid agreeing on the uncertain elements of PIP studies. Instead, the agency will allow sponsors to agree to stepwise PIPs (sPIPs) that cover a partial development program. The partial programs require the sponsor to develop a full PIP once the missing information is available.
 
EMA’s new guidance lists the general principles of sPIPs and explains how to apply for and modify the partial programs. The partial programs must contain a minimum set of data, including the condition, preliminary outline of planned studies based on available evidence, and a PIP completion date.
 
At the time of the initial PIP review, the sponsor and EMA’s pediatric committee will agree on a schedule of modifications based on certain milestones or timelines. EMA wants to agree on clear deadlines for developing the full PIP and avoid the submission of high numbers of minor modifications on an ad-hoc basis.
 
EMA Guidance
 
Swissmedic eliminates need for printed package leaflets for some pharmaceuticals
 
The Swiss Agency for Therapeutic Products (Swissmedic) has freed manufacturers of the need to provide printed package leaflets with some medicines.
 
Companies that make medicinal products for use exclusively by healthcare professionals can put a QR code on the outer packaging instead of including a paper leaflet. The exemption from the need to provide paper leaflets applies to drugs for which no patient information is currently required. The QR code should link directly to an online copy of the information for healthcare professionals.
 
Swissmedic updated its guidance to permit reliance on QR codes in response to a Swiss parliamentary initiative intended to simplify regulations for purchasing medicines in hospitals to reduce costs. A Swiss politician introduced the plan in 2023. Because only a few drugs or package sizes are used exclusively in hospitals, the Swiss Federal Council predicted changing the rules would have minimal impact.
 
Swissmedic Notice
 
EMA shares extensive update on the classification of post-authorization changes
 
EMA has made extensive changes to a question-and-answer document about post-authorization changes by marketing authorization holders.
 
The updated section starts with a new question about how to apply for a change in the name or address of a manufacturing site. EMA’s response explains what classification category applies, provided that the change is purely administrative and does not involve the physical relocation of production. A different classification category applies if manufacturing has moved to another location.
 
EMA has added other new questions about variations to replace the rabbit pyrogen test in marketing authorization dossiers, changes in the clinical use of marketed products, and certain updates to package leaflets. The document also features updates to EMA’s answers to multiple existing questions, including the addition of information about variations introducing additional manufacturing or batch testing sites.
 
EMA Q&A