Euro Roundup: Notified bodies propose changes to Commission plan for risk-adaptive device surveillance
Notified body association Team-NB has suggested changes to the European Commission’s proposals for risk-adaptive surveillance of medical devices.
Currently, certificates issued by notified bodies for medical devices and in vitro diagnostics (IVDs) expire after five years. As part of its efforts to simplify the medtech rules, the Commission proposed removing the maximum validity period, arguing that it creates administrative burden, uncertainty, and unnecessary costs. Instead, the Commission wants notified bodies to perform periodic, risk-proportionate reviews.
Team-NB has published two near-identical proposals to complement the Commission’s reforms, one for the Medical Device Regulation (MDR) and another for the IVD Regulation (IVDR). The complementary proposals reflect a belief that notified bodies need “a reliable assessment of risk, based on a systematic process,” to implement the Commission’s changes.
“Increased monitoring intensity at the outset provides the basis for assessing the risks associated with a specific device and its manufacturer, and for determining the future level of monitoring based on that assessment,” Team-NB said.
The proposed system permits notified bodies to adjust the intensity, frequency, and modalities of their surveillance activities based on objective and documented criteria. The criteria include post-market surveillance and vigilance data, audit and sampling results, technical documentation findings, the effectiveness of corrective and preventive actions, and the maturity of the quality management system.
Notified bodies would have the option to reduce surveillance intensity when a company shows sustained compliance and stable post-market performance. De-escalation of surveillance will be “stepwise and time based,” with notified bodies able to lower it three years after conformity assessment. The proposal allows a further reduction in surveillance if no compliance or risk issues have emerged after six years.
Re-escalation may be immediate, triggered by events such as serious incidents and field safety corrective actions. Notified bodies should ensure they have the capacity to re-escalate surveillance promptly when needed. At any surveillance level, the proposals allow competent authorities to impose additional measures at any time to address specific risks to health, safety, or compliance.
Team-NB’s core proposals are the same across the MDR and IVDR documents. Differences between the proposals include IVDR sections on assessing clinical performance and determining the frequency of batch testing by the European Union reference laboratory.
European Commission begins second phase of drug-device coordinated assessment pilot
The European Commission has launched phase two of its pilot project on the coordinated assessment of studies that combine drugs and devices.
Different EU regulations cover assessments of medicinal products, medical devices, and IVDs. Products that combine drugs with a medical device or IVD are covered by two regulations. Through the COMBINE program, the Commission and Member States are addressing the interface between the regulations to help developers run combined studies.
Phase two of the pilot opens the program to multinational investigational medicinal product clinical trials combined with studies of unauthorized medical devices, IVDs, or companion diagnostics. Combined studies of Advanced Therapy Medicinal Products are also newly eligible for the pilot program.
Other changes include options for single or separate sponsors and the exploration of single protocols and joint documents. The Commission will launch a procedure for substantial modifications in combined studies authorized in the pilot later in phase two.
Sponsors interested in participating in the pilot must submit expressions of interest by the 23rd of the month preceding the month in which they intend to file their applications. The first monthly application window will open in September 2026, meaning the deadline for the initial round is 23 August. Phase two will run for at least one year. The Commission will favor studies involving “a broad set” of EU countries.
The second phase builds on eight applications that were accepted into the first part of the pilot project. The Commission launched phase one in June 2025, limiting eligibility to combined studies run by a single sponsor. Officials authorized one application in March. The other seven applications were in progress or concluded as of 28 May.
MHRA cautions on use of AI in GxP inspection responses
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday published a blog post noting some shortcomings in AI-generated good practice (GxP) inspection responses it has received.
MHRA said that while AI tools can be beneficial when used properly, it has received AI-generated responses that fell short of its expectations. The agency said that these have included responses that referenced guidance that doesn’t exist and responses to “serious deficiencies that appear designed to mislead rather than address underlying problems.”
In some cases, these issues caused MHRA to commit disproportionate resources to review and respond to the responses. One case in particular required the review of multidisciplinary teams and took about five times longer to respond to. “Aside from being a strain on resource, the use of AI being applied inappropriately has shifted from theoretical risk into actual, realised risk,” MHRA wrote.
The regulator stressed that companies are responsible for the accuracy of their responses and must ensure that they are factually accurate and verifiable and should be technically reviewed by appropriate personnel.
Swissmedic starts mandatory device and diagnostic registration in swissdamed database
The Swiss Agency for Therapeutic Products (Swissmedic) made the registration of devices, systems, and procedure packs in the swissdamed database mandatory on 1 July.
Manufacturers and their authorized representatives must register the products in swissdamed before placing them on the Swiss market. The standardized digital system replaces the old notification procedures for Class I medical devices, systems and procedure packs, MD-DEVIT products, and IVDs in all risk classes.
A transitional period applies to some devices until the end of the year. Devices that have to be reported to Swissmedic because of serious incidents, field safety corrective actions, or a trend are ineligible for the transitional period and must be registered from 1 July.
Swissmedic is charging CHF 200 ($248) for the first unique device identifier. After that, companies will pay CHF 20 for each additional device identifier. The maximum a company can pay is capped at CHF 10,000 a year. Swissmedic will send invoices from January, retrospectively taking into account devices registered by that date.
Sellers of repackaged, relabeled, and custom-made devices should keep using form-based notifications. The old notification system also continues to apply to “in-house devices” manufactured and used in healthcare institutions.
Final EU approval of US trade agreement triggers pushback from drug and device industries
The formal adoption of the EU-US trade deal has prompted drug and device trade associations to renew their calls for relief from tariffs imposed under the agreement.
EU negotiators agreed to a 15% cap on tariffs for medical technologies and innovative medicines exported from the region to the US. The two sides reached the agreement last year, but the European Council only formally adopted two regulations implementing the tariff-related commitments last week. The deal supports a stable, predictable, and mutually beneficial transatlantic trade relationship, the Council said.
EFPIA, which represents branded drugmakers, accepted that the deal “brings a degree of certainty for EU-based companies.” However, the trade group argued that the deal “is far from an optimal outcome for the sector.” EFPIA is unsure how the 15% tariff cap will affect “patient care, global supply chains, and the sector's footprint in Europe.”
MedTech Europe called for products made by its members to receive relief from the tariffs. The medtech trade group wants the deal to provide the basis for continued talks, including about sector-specific tariff relief.
Swissmedic updates templates for patient and healthcare professional information documents
Swissmedic has published updated patient and healthcare professional information templates that must be used from 1 July.
The agency released the updated templates alongside redesigned websites for accessing information for patients and healthcare professionals. Longer instructions for use at the end of information documents are collapsed under a tab on the new websites, making them less visible. In response, Swissmedic added an optional section titled “instructions for use” to both templates.
“This option is only intended for extensive instructions for use or those with figures, which cannot be incorporated in the sections specified in the [Therapeutic Products Licensing Requirements Ordinance],” Swissmedic said.
Companies bringing new products to market must use the updated templates. For products already on the market, companies can adopt the new template when applying for variations. Swissmedic wants companies with instructions for use at the end of the document to update the relevant texts using the new templates at the earliest opportunity.
