Euro Roundup: Notified bodies push to extend transition timelines for MDR and IVDR revisions

A notified body trade group has called for the European Commission to extend its timelines for adopting planned changes to the medtech regulations.

The trade group, Team-NB, offered preliminary feedback on the Commission’s proposals in the days after they were made public. At that time, Team-NB said the timelines are too short and should be replaced with more realistic deadlines without suggested alternative durations. The group provided more details of its requests in a full position paper the following week.

Team-NB named the lack of a transition timeline for implementing changes to the quotation process as a problem. The trade group said the Commission proposed defining the information notified bodies should collect and the elements they should include in quotes. Team-NB welcomed the minimum information requirement, which it said would enable more accurate quotes, but flagged implementation issues.

The trade group proposed establishing at least a six-month transition period for these changes. Team-NB said the transition period is needed to allow notified bodies and manufacturers to adjust processes to collect and submit more information during applications.

Other areas of concern include the maximum timelines and clock-stops for various certification activities. Team-NB wants the Commission to extend the timeline for transitioning to the new deadlines from three months, a target it called “extremely short,” to at least 12 months.

The trade group also has concerns about maximum timelines. Team-NB said the proposed timelines “are challenging and unrealistic.” The trade group said the proposed 90-day timeline for technical documentation assessments is challenging, “especially for complex devices with multiple competencies involved.”

Team-NB said the timeline would force notified bodies to use experienced staff to assess the documents, hindering their ability to train employees, and make it hard to work with external experts. Projects that require reviewers with different competencies to collaborate on assessments would be very hard to finish by the deadline, the trade group said. Team-NB proposed extending the timeline to 150 days.

The trade group named the 15-day deadline for reaching the final decision and releasing the certificate as another problem. Currently, the proposal lacks a stop-clock period and, in the trade group’s view, the 15-day limit “is restrictive due to the limited number of qualified staff.” Team-NB recommended adding one clock-stop for when manufacturers provide new information and extending the deadline to 25 days.

Team-NB’s final concerns with the timelines center on the planned use of different deadlines for initial certifications and changes. The trade group said the split will create unnecessary complexity for notified bodies when implementing and monitoring the new process. To avoid that complexity, Team-NB wants the Commission to set the same timelines for initial certifications and changes.

Team-NB Notice

Swissmedic shares guidance on arranging meetings to clarify GMP requirements

The Swiss Agency for Therapeutic Products (Swissmedic) has published guidance on how companies can request meetings to discuss good manufacturing and distribution practices (GMPs/GDPs).

Swissmedic offers companies that hold, or are in the process of applying for, an establishment license the chance to meet to clarify the GMP and GDP requirements and expectations for planned projects, extensions, or amendments to establishment licenses at an early stage. The meetings are designed to support the consistent implementation of legal requirements and efficient project execution.

Manufacturers that want to request scientific GMDP meetings can now refer to Swissmedic guidance on the process. The document lists the roll-out of innovations such as continuous manufacturing, robotic filling lines, rapid microbiological methods, and the use of artificial intelligence in computer-controlled systems among the types of issues that can be discussed at the meetings.

Swissmedic has listed the information companies should include in meeting applications. The agency will evaluate information to determine if the applicant is eligible for a meeting. Swissmedic will reject requests that are outside of the meeting scope defined in the guidance. Other sections of the guidance detail the content, duration, and procedure of GMDP meetings.

Swissmedic Notice

EMA identifies ways to improve communication after consulting with industry

A consultation with industry has generated recommendations for how the European Medicines Agency (EMA) can improve its communication.

EMA formulated the recommendations after talking to 19 industry organizations. Stakeholders called for changes to the timelines for consultations, coordination between publications and targeted mailing, and the provision of versions of updated documents with tracked changes. If it is unable to track changes, the respondents at least want EMA to specify the nature of its updates to documents.

In response, EMA recommended that its teams should ensure adequate and realistic timelines for public consultations and suitable timing of events and other initiatives involving stakeholders. EMA also plans to act on the coordination request to ensure stakeholders have timely access to published information.

The agency’s recommendations fell short of mandating tracked changes but do reflect the feedback. EMA recommended enhancing “transparency on the nature of changes of updated documents.” The agency also noted the need to ensure the transparency of the outcomes of consultations and surveys, highlighting how stakeholders’ feedback was implemented when possible.

Other feedback reinforced EMA’s commitment to existing practices. The agency concluded it should maintain targeted emailing as the main channel to inform the industry about key updates and events.

EMA Report

MDCG publishes guidance on postmarket surveillance of medical devices and IVDs

The Medical Device Coordination Group (MDCG) has published guidance on postmarket surveillance of medical devices and in vitro diagnostics (IVDs).

MDCG created the document to describe the postmarket surveillance (PMS) systems that companies need. PMS systems enable companies to keep their devices compliant with the medtech regulations and benefit from real-world experience gained from the use of their products. The European Union medtech regulations made structured and proactive PMS an integral part of quality management.

The MDCG guidance describes PMS systems, plans, and the main activities within the systems. MDCG has also clarified how PMS systems interact with other aspects of the quality management systems (QMS) described in the medtech regulations.

MDCG said a PMS system “must be suited to actively and systematically gathering, recording, and analyzing relevant data on the quality, performance, and safety of a device throughout its entire lifetime.” Systems must also enable companies to draw conclusions and support preventive or corrective actions. The guidance features specific advice for manufacturers of custom-made devices.

Another part of the text addresses the PMS plan. Manufacturers should consider how to systematically and proactively collect experience from real-world use of their devices while the products are still being developed. PMS plans can cover groups of devices, for example when products share a manufacturing process, design, and intended purpose.

MDCG published the guidance days before sharing an updated manufacturer incident report (MIR) form. Companies use the form to report serious incidents to the competent authority of the member state where the incident occurred. Device and IVD manufacturers must start using the new MIR form by early May.

MDCG Guidance, MIR Form

Other News:

Swissmedic has set deadlines for the mandatory registration of devices, systems, and procedure packs on its swissdamed database. Registration will become mandatory July 1, though a transition period will be in place until the end of 2026. Swissmedic adopted the deadlines after the European Union set a May 28 start date for mandatory use of Eudamed, with a subsequent six-month transition. Swissmedic Notice

The European Directorate for the Quality of Medicines and HealthCare (EDQM) is seeking feedback on 11 draft revised monographs. EDQM is accepting input on the documents published in Pharmeuropa 38.1 until 31 March. EDQM Notice

Euro Roundup: Notified bodies push to extend transition timelines for MDR and IVDR revisions

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