Euro Roundup: Notified bodies propose EU-level medtech coordination and support structure

Notified bodies have shared their vision for the future governance of the medical device sector in the European Union, making the case for a central structure that reduces duplication, streamlines decision-making and provides a single interface for stakeholders.

Team-NB, the European association of medtech notified bodies, published the paper with NBCG-Med, a notified body coordination group established as part of the medtech regulations. The groups framed their proposals as a response to a medical device regulatory framework that “faces fragmentation and inconsistent implementation, hindering safety, innovation and timely access.”

In response, the groups have proposed “a future governance model that integrates centralized support mechanisms, enhanced scientific and regulatory coordination and sustainable funding.” The plan is built around the Medical Device Coordination Office (MDCO), a proposed central coordination and support structure.

MDCO will oversee notified bodies, coordinate classification and qualification decisions, create guidance on how the legal system should work and develop technical and clinical guidelines. Other planned tasks for MDCO include coordinating consultation procedures, facilitating special pathways for certain devices and coordinating vigilance.

Notified bodies remain key players in the proposed system, with Team-NB and NBCG-Med making the case that their role as “as technical, regulatory and clinical ‘extended arm’ of the authorities should be maintained.”

“Moreover, notified bodies operate under strict designation and oversight criteria, ensuring independence, competence and impartiality. Their involvement in a centrally coordinated system — such as through the proposed MDCO — would enhance consistency and efficiency without compromising the decentralized strengths of the current model,” the notified body groups said.

The proposed model would give notified bodies advisory roles in decision-making structures. Team-NB and NBCG-Med said notified bodies could add value to expert committees, guidance development, special pathway procedures and classification discussions. The groups are also calling for NBCG-Med to get an expanded mandate to boost its contribution to guidance development and harmonization efforts.

Team-NB and NBCG-Med propose funding MDCO through a mix of user fees and contributions from the EU budget. Companies would pay “modest fees associated with activities in EUDAMED,” the groups said, and could pay additional fees for specific services such as early advice.

Another set of proposals covers special pathways and early advice. The notified bodies said they support the creation of a special pathway for devices that face disproportionate challenges under the medtech regulations, such as pediatric, orphan and breakthrough products.

“However, such pathways must not be implemented solely between manufacturers and individual notified bodies, as this could lead to inconsistencies and regulatory uncertainty. Instead, a coordinated process with clear guidance and oversight is essential,” the notified bodies said.

The notified bodies proposed adding a special pathways annex to the medtech regulations to define the eligibility criteria, minimum data requirements and other details. The proposals include a suggested process for seeking special pathway status.

Team-NB Paper

EMA publishes guidance on masking personal data in individual case safety reports

The European Medicines Agency (EMA) has published a guideline on masking personal data in individual case safety reports (ICSR) submitted to EudraVigilance.

EMA and the Heads of Medicines Agencies (HMA) provided the advice in an addendum to a module of their guideline on good pharmacovigilance practices. The regulators created the addendum in response to an audit of EudraVigilance pseudonymization procedures and personal data masking by the European Data Protection Supervisor. The audit identified a need for a common masking policy.

The addendum lists data elements that are not required for signal management, duplicate detection or ICSR processing and should be masked. EMA and HMA also listed data elements such as the sender’s name that should be left blank. Another set of data elements is listed as not containing personal data and being required for pharmacovigilance processes.

The longest list covers elements that may contain personal data and are needed for pharmacovigilance processes. While the data elements may contain personal identifiers or quasi-identifiers, the information is needed for signal management, duplicate detection and ICSR processing. As such, EMA and HMA said available data related to the elements should not be masked or left blank by senders.

EMA Guideline

MedTech Europe calls for more risk-based approach to sampling under IVDR

MedTech Europe has called for sampling to be made more proportional to the risk classes of devices to avoid a disproportionate burden on in vitro diagnostic (IVD) manufacturers.

Medical Devices Coordination Group guidance requires sampling of Class B and C devices under the IVD Regulation to be proportionate to the total number of devices under that certificate. MedTech Europe said “it is expected that 15% of technical documentation is reviewed per representative group of devices during each five years cycle which notified bodies may reduce to 5%.”

Class B and C devices account for more than 90% of IVDs on the EU market, the trade group said, and as such the 15% sampling requirement “has a high burden on IVD manufacturers, especially small and medium-sized enterprises.” Average costs per one technical file assessment during an initial certification audit can total €38,000 ($43,000), according to MedTech Europe.

Adopting a model based on risk classification rather than quotas “could significantly reduce burden stemming from duplicative sampling which has little added value to ensuring device safety and performance as compared to other more valuable means,” the trade group said. The position paper includes simulations of the impact of sampling on the IVD sector.

Press Release

European regulators set out next steps for controlling nitrosamine impurities

EMA and HMA have outlined areas for further development of the European Medicines Regulatory Network’s (EMRN) response to nitrosamine impurities in human medicines.

The next steps include development of an International Council for Harmonisation guideline on assessing and controlling mutagenic impurities and continued evaluations of scientific development by EMRN. The ongoing evaluations could lead to updates to EU guidance, if needed. EMRN also outlined the role that marketing authorization (MAHs) holders have to play.

“EMA, together with EU national competent authorities, remind MAHs of their responsibility to actively follow the latest science and policy developments, revisit nitrosamine risk assessments, conduct confirmatory testing as appropriate and ensure the quality, safety and efficacy of their medicines for the safety and well-being of patients,” EMRN said.

EMRN published the next steps in a report on its response to nitrosamine impurities. Compliance with requests to MAHs was generally good, EMRN said, and patient safety has been carefully balanced with the need to ensure the availability of important medicines. Relatively few drugs have been made unavailable and patients have not been unduly exposed to impurities, EMRN said.

EMRN Report

Other News:

EMA has recommended approval of the first reformulation of an inhaled drug with an environmentally friendly gas propellant. The recommendation covers changes to the composition of AstraZeneca’s Trixeo Aerosphere and Riltrava Aerosphere to replace the existing gas propellant with an alternative that has lower global warming potential. EMA Notice

EMA’s Paediatric Committee (PDCO) has elected Sabine Scherer as its new chair. Scherer, whose three-year mandate will start in September, became a PDCO committee member in 2016 and served as its vice-chair from 2019 to 2022. At Germany’s Federal Institute for Drugs and Medical Devices, Scherer serves as senior clinical assessor, deputy head of pediatric and orphan medicinal products. EMA Notice

Euro Roundup: Notified bodies propose EU-level medtech coordination and support structure

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