We simplify market access for medical devices

European Commission

A new MDCG 2025-10 on Post-Market Surveillance under EU MDR/IVDR has been published. It compiles the PMS requirements scattered in different sections of the Regulations. The following points are worth considering:

• Art.5(5) devices (in-house devices) are out of scope of this guidance document but healthcare institutions are still expected to implement a system to review the experience gained from the use of such devices.
• In addition to PMS requirements under the EU MDR, a PMCF Plan is expected for custom-made devices.
• In a lenient interpretation of EU MDR/IVDR Annex III, the procedures required in a PMS Plan (e.g. Vigilance, complaint handling, communication with competent authorities) can be merely cross-referenced instead of described. 
• The PMCF/PMPF Plan is an integral part of the PMS Plan, or, where applicable, the explanation why PMCF/PMPF activities are not required.
• PMS data quality and integrity should be considered to ensure that the information is reliable. Data from different sources should be compared, and conflicting data identified and evaluated. Examples of data sources are presented in Table 2 of the document. 
• Table 3 describes the interactions between the PMS processes and related processes, e.g. risk management, design and manufacturing, clinical/performance evaluation, CAPA, or usability, and Annex 2 provides an IVD and a non-IVD example on how to proceed.

Swissmedic

Swissmedic has published on its website clarification relative to the timelines for mandatory registration in swissdamed’s UDI module. 

Despite the postponement of EUDAMED’s UDI module, the deadline for registration of devices, systems, and procedure packs in swissdamed is maintained on 1 July 2026, with a transition period until 31 December 2026. This close deadline to EUDAMED’s will need careful consideration by manufacturers and Swiss Authorized Representatives to ensure that the necessary XML files are ready for uploading in swissdamed.

European Commission

Commission has published a proposal to amend the EU MDR and IVDR, introducing significant changes intended to streamline requirements for all stakeholders. The proposal shall now undergo review by the Parliament and Council, and there is no guarantee that all proposed amendments will be adopted in the final form. 

Among the most striking changes, there is the proposal to move the EU MDR and IVDR from Section A to Section B in Annex I of the EU AI Act, which would mean that Notified Body certification under the EU AI Act  would not be required at all for AI-enabled medical devices and IVDs.

A new MDCG 2025-9 Guidance on Breakthrough Devices (BtX) has been published, with the following key points:

• Definition: Establishes criteria for Breakthrough Devices (BtX), requiring both a high degree of novelty and a significant positive clinical impact for life-threatening or irreversibly debilitating conditions.
• Pathway: Facilitates a streamlined CE marking process by balancing pre-market and post-market clinical evidence, allowing for earlier access to innovative MDs and IVDs.
• Support: Provides designated devices with priority access to Expert Panel scientific advice, structured dialogue with Notified Bodies, and potential fast-track conformity assessments.
• Compliance: Emphasizes robust PMCF/PMPF plans and registry enrollment to resolve clinical uncertainties remaining at the time of certification.

A revision of MDCG 2025-7 on the timelines of Master UDI-DI (Rev.1) has been published published, with the following key changes:

• Alignment with Reg. (D) 2025/788 and Reg. (D) 2025/1920
• Alignment with MDCG 2024-14 Rev.1 and MDCG 2025-8
• Updates related to EUDAMED timelines

The EU Commission has published the draft Implementing Regulation on uniform quality management and procedural requirements for NBs. Key points:

• Harmonized Assessment Timelines: Sets mandatory maximum timelines for NBs, including 30 days for application review, 120 days for QMS audits, and 90 days for technical documentation assessment.
• Cost Transparency: Requires NBs to provide standardized, detailed quotations covering all assessment and surveillance costs before manufacturers sign a contract.
• Predictable Re-certification: Mandates that NBs notify manufacturers one year before a certificate expires and complete re-certification reviews within 60 days
• Structured Interchanges: Limits the number of allowed interruptions during the conformity assessment process to prevent indefinite delays caused by back-and-forth queries.
• Mandatory Performance Reporting: Requires NBs to track and publish annual reports starting in 2028 on their median assessment durations and cost variances to improve market competition.

Swissmedic

Swissmedic has published an updated version of their Swiss guide for manufacturer’s MIR. This new version introduces significant content and structural changes on how to complete the new MIR form v. 7.3.1.

• Manufacturers are expected to complete all fields in the form, even if not marked mandatory, unless there is a transparent reason for omission.
• “One device, one MIR”: if an incident involves multiple devices and the primary cause is unclear, a separate MIR must be submitted for each device. If the responsible device is known, associated devices must be listed in section 2.6.
• “One incident, one MIR”: manufacturers must submit one MIR per incident. The use of date ranges to cover multiple incidents involving the same device in a single report is prohibited.
• Section 5 on Swissmedic requirements has been expanded and restructured into three distinct subsections: General rules (section 5.1), formal requirements (section 5.2), and content-related requirements (section 5.3).
• The new section 5.3, includes detailed instructions on specific MIR fields.
• A new Section 6 on Transition period has been added, clarifying that the new MIR 7.3.1 form will only become mandatory in Switzerland once the EU transition period has expired.