We simplify market access for medical devices

European Commission

The EU Commission has published a welcome Implementing Reg. (EU) 2026/977 that harmonizes procedural requirements in conformity assessments by Notified Bodies under the EU MDR and IVDR.
It introduces:

• Maximum timelines:
  • Application review & contract: 30 days from receipt of a complete application
  • QMS auditing: 120 days from start of the audit programme to final review
  • Product verification (Technical Documentation): 90 days
  • Certification decision: 20 days after the final review
• Maximum number of timeline interruptions at each stage (e.g., only once during application review, and up to four times during QMS auditing or product verification). 
• Financial transparency: Notified Bodies must provide detailed quotations including estimated surveillance and unannounced audit costs. Manufacturers must be informed in advance of any cost increase exceeding 10%.
• Notified Bodies must publish annual reports by April 30th detailing median assessment durations and total costs.
• The re-certification process is streamlined to focus on changes, PMS data, and state-of-the-art updates, prohibiting the repetition of initial certification assessments.

Team NB

Team-NB has published a position paper on the clinical evaluation based on non-clinical data only (e.g., bench testing, in-silico, animal/cadaveric testing, or validated simulations), per EU MDR Article 61(10). The paper provides: 

• A set of helpful questions and examples to guide manufacturers in the potential applicability of Article 61(10), which revolves around: intended clinical performance and claims,  device/body interaction, and risk management. 
• Insights to Notified Body’s expectations on the clinical evaluation documentation under Article 61(10), as well as common deficiencies in the manufacturer’s justification, the analysis of the state-of-the-art, the approach to clinical evaluation and PMS/PMCF activities. 

Overall, this new position paper broadens the approach to Article 61(10), while simultaneously clarifying boundaries, and is particularly favorable for medical device software.

Swissmedic

Swissmedic has updated its guidance (Version 3.0) for submitting MIR reports, effective May 1st , 2026. The key changes are:

• New reference to “Selection of IMDRF AET Codes”, a guide for industry partners and healthcare providers.
• Explicitly prohibits using a “time range” for the incident date to cover multiple incidents in a single MIR.
• New symptoms arising after an initial report should be described in a follow-up report.
• Manufacturer and CH-REP details must align with the data registered in swissdamed.

Team NB

Team NB has published a new version of Best Practice Guidance for the Submission of Technical Documentation (V4) under EU MDR Annex II and III. The key changes are as follows:

• Clarification on use of harmonised standards
• Incorporates recent regulatory developments, specifically the updated e-IFU Regulation (EU) 2025/1234 and considerations for the AI Act.
• Reflects changes in updated standards and incorporate new MDCG guidances
• Significant additions of “common pitfalls” observed by notified bodies across all domains, including device description, GSPRs, risk management, V&V, biocompatibility, software, packaging, and sterilization.
• Updated and expanded content specifically targeting high-impact areas such as AI/ML devices and cybersecurity.
• etc.

The new Team-NB’s Code of Conduct (Version 5.2) for Notified Bodies was published. It aligns time to review software between MDR and IVDR and a table of content was added.

Swissmedic

Swissmedic just published on its website a notification to Swiss manufacturers and CH-REPs about the upcoming focus campaign 2026 to review post-market surveillance documentation. The same notification has been simultaneously sent to the concerned Economic Operators via e-mail.

Swissmedic has also published a notice for in-house medical devices and IVDs indicating that the collective notification of products manufactured and used in healthcare facilities will end on January 1, 2027. From this date on, notifications pursuant to Art. 10 of the IvDO and Art. 18 of MedDO must be submitted exclusively as individual notifications.

European Commission

A revision of MDCG 2021-24 (rev.1) on the classification of medical devices under the EU MDR has been published. 

• The definition of the “procedure” used to introduce an implantable device in section 3.1.4 has been broadened. The word “surgical” is replaced with “clinical,” and the guidance now explicitly clarifies that the term “clinical procedure” encompasses both surgical and non-surgical procedures. 
• New examples have been added under Rules 2, 8, 10, 12, 16, and 22.
• The structure for Rule 9 (Active therapeutic devices) has been changed to better match the EU MDR.
• The section on “Practical issues of classification” has been expanded for Rule 8 (new notes 1-7, such as specific interpretations for spinal hooks) and Rule 22 (new note regarding pads/electrodes for automatic external defibrillators, which are Class III if they are an integral part).

The MDCG has published three new documents (MDCG 2026-1, 2026-2 and 2026-3) regarding the European Medical Device Nomenclature (EMDN). This series includes the summary of 2025 EMDN code submissions, the change log, and the version history. A Guidance on the Version History has also been published.

The EU Commission has published a new version of the Manual on Borderline and Classification (Version 5, April 2026). Changes include: 

• New Qualification case:
  • Device intended to administer a medicinal product (Section 1.1.9.7). A single-dose mini tube with a long nozzle intended for rectal insertion and administration of a medicinal product qualifies as a medical device. 

• New Classification cases:

• • Penis holster (Section 1.2.1.2): is Class I per Rule 1, as it is not considered an invasive device through body orifice.
  • Syringe containing glass beads (Section 1.2.3.1): is Class IIb per Rule 3, because the glass beads contact the blood to initiate coagulation, thereby altering its biological and chemical composition. 
  • Needles for root canal irrigation (Section 1.2.6.1): are Class IIa per Rule 6, because needles meet the definition of a surgically invasive device as the root canal is accessed via a drilled, surgically created opening. 
  • Saline solutions for nasal irrigation (Section 1.2.21.1): are Class IIa per Rule 21, as they are substance devices that achieve their intended purpose of dissolving mucus in the nasal cavity.