Euro Roundup: MedTech Europe seeks changes to proposed MDR revisions
MedTech Europe has shared feedback on planned changes to the European Union’s medical device and diagnostic regulations, offering high-level support for the revisions while calling for tweaks to aspects of the proposals.
Facing long-running challenges to the implementation of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), the European Commission proposed changes last year to make the rules easier and faster. MedTech Europe, a trade group representing device and diagnostic companies, said it fully supports the Commission’s goal of streamlining the regulations and urged the European Parliament and Council to advance the reforms swiftly.
“The cost of delay in addressing the system’s shortcomings is concrete and cumulative,” MedTech Europe said. “Companies are already redirecting investment away from Europe, patients face avoidable disruptions to the technologies they depend on, and the EU falls further behind competing jurisdictions. The window to act is now.”
The Commission’s focus on simplification and international cooperation will make a tangible difference to companies and patients, MedTech Europe said. Yet while calling for lawmakers to preserve those core elements of the reforms, the trade group pushed for the strengthening of some provisions and a rethink of one proposal.
MedTech Europe wants the EU to rethink its approach to reprocessing single-use devices. Under the Commission’s proposals, manufacturers will be obliged to provide a justification for a “single-use” claim. The Commission supports the reprocessing of all medical devices without single-use status under the manufacturer’s instructions. A person who fully refurbishes a device will be classed as the manufacturer.
The trade group wants to remove the burden on manufacturers to justify that devices cannot be reused. Rather, the indication should be based on risk management and risks from reusing the device, MedTech Europe said.
MedTech Europe also flagged several areas that it believes need strengthening. Proposed breakthrough and orphan device pathways need to explicitly include pediatric devices, the trade group said. MedTech Europe wants lawmakers to align the IVDR orphan device threshold with the established definition of a rare disease to avoid excluding diagnostics.
Other areas MedTech Europe wants to strengthen involve cybersecurity reporting, artificial intelligence requirements, and blood draws. The trade group framed the feedback as a push to adopt proportionate approaches that avoid unnecessary burdens while maintaining robust safeguards.
Notified bodies share guidance on acceptability of nonclinical medical device data
A notified body association has published a position paper on the acceptability of using nonclinical data to show the safety and performance of a medical device.
Under MDR, companies typically need to use clinical data to show their devices conform to the relevant safety and performance requirements. An exceptional pathway allows companies to rely on nonclinical evidence, provided they can justify that clinical data are inappropriate for verifying the predefined safety, performance, and benefit-risk criteria.
Notified body association Team-NB has shared advice on what justifications may be acceptable. In the position paper, Team-NB said that the claims that clinical data are “not available” or “difficult to generate” are not valid arguments. Companies’ justifications must address the intended clinical performance and claims, interaction between the device and the human body, and risk management.
The position paper covers the level of information notified bodies need in each area to determine that the use of nonclinical data is justified. Discussing clinical performance and claims, Team-NB said notified bodies need to understand the predefined parameters that support assessment of a device’s benefits. It is not acceptable to say a device does not provide any clinical benefit, Team-NB said.
Team-NB published the position paper alongside an update to an existing document on best practices for the submission of technical documents under two MDR annexes. Changes include clarification on the use of harmonized standards, the addition of common pitfalls seen by notified bodies, and updated information on high-impact topics including artificial intelligence and cybersecurity.
Swissethics starts piloting accelerated assessments of clinical trial applications
The Swiss Association of Research Ethics Committees (Swissethics) has started a fast-track pilot intended to significantly reduce processing times for applications to run medicinal product clinical trials.
Swissethics’ pilot builds on a fast-track project initiated by the Swiss Agency for Therapeutic Products (Swissmedic) last year. Under Swissmedic’s pilot, the regulator accelerated the review of applications to run studies with high medical needs or to assess investigational medicinal products that it had reviewed and authorized in previous clinical trials.
The same criteria apply to Swissethics’ pilot. Applicants with written confirmation from Swissmedic that a clinical trial is eligible for the fast-track procedure can submit the paperwork to the competent ethics committee as part of their initial applications. The ethics committee, and local ethics committees when relevant, will then prioritize the review of the study.
Swissethics’ statement lacks a timeline for processing fast-track applications. Swissmedic’s fast-track pilot lacks defined or legally binding deadlines, but the regulatory agency promised to beat the timelines set in the Swiss Clinical Trials Ordinance.
Council of Europe adopts recommendations on remote provision of medicines
The Council of Europe has adopted a legal instrument on best practices for the remote and online provision of medicines.
Coordinated by the European Directorate for the Quality of Medicines and HealthCare (EDQM), the legal instrument establishes a framework for improving access to medicines while maintaining high standards of quality and safety. EDQM worked with regulatory authorities and other stakeholders on the document to address the rise of digital technologies, remote services, and online platforms.
The framework covers every step in the medication process, from the identification of a patient’s need for a drug through to follow‑up care and pharmacovigilance. Competent authorities should ensure online and remote providers support patients’ participation in the pharmacovigilance process and maintain lists of medicines that are authorized for online and remote provision.
EDQM Notice, Committee Recommendations
Swissmedic posts guidance on meetings to discuss controlled substance regulation
Swissmedic has shared guidance on its meetings with companies to discuss licenses to handle controlled substances.
The agency meets with companies to clarify narcotic control issues, providing information that could help businesses implement projects involving controlled substances. Swissmedic has created guidance to explain the meetings’ rules and processes and ensure its interactions with companies are consistent and clear.
In the guidance, Swissmedic explains each step in the process, from the need for companies to request meetings four to eight weeks before their desired date through to the provision of meeting minutes after the interaction. Swissmedic charges a fee based on the administrative and scientific work involved.
Other News:
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has named Jason Bonander as its chief digital and technology officer. Bonander was previously chief information officer at the US Centers for Disease Control and Prevention. At MHRA, Bonander will help modernize the agency’s portfolio of services and platforms to make regulation faster, more efficient, and more transparent. MHRA Notice
The European Medicines Agency has published product-specific bioequivalence guidance for liraglutide prefilled pens and tafamidis soft gelatin capsules. Liraglutide is a GLP-1 receptor agonist that Novo Nordisk sells as Saxenda and Victoza for weight loss and diabetes, respectively. Tafamidis is a treatment for forms of transthyretin amyloidosis that Pfizer sells as Vyndaqel and Vyndamax. Liraglutide, Tafamidis
