To close out January 2025, we are reporting on medical device regulatory developments in the European Union and Switzerland, including IVDR compliance challenges cited in the MedTech Europe 2024 Regulatory Survey, as well as guidance, FAQ, and form updates from Swissmedic.
On 29 January 2025, the European Medicines Agency (EMA) published new scientific advice from the IVD Expert Panel regarding SARS-CoV-2 tests. This guidance clarifies that while SARS-CoV-2 can still cause severe illness, it no longer poses a significant mortality risk to the general European population. As a result, the reclassification of SARS-CoV-2 tests may occur, potentially changing their risk classification from Class D to Class C under Regulation (EU) 2017/746. However, IVDs can continue to be marketed under their current risk class if they meet all regulatory requirements. The expert panel emphasizes that the advice is non-binding and each device’s classification should be determined individually by the manufacturer.
The MedTech Europe 2024 Regulatory Survey, released on 15 January 2025, presents key insights into the challenges faced by manufacturers under the In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR). The survey reveals significant concerns regarding costs, timelines for conformity assessment, and regulatory predictability. Manufacturers identified clinical evaluations, Post-Market Surveillance (PMS), and certification as the primary cost drivers. It also highlights the perceived regulatory burden and cost, while suggesting opportunities to improve conformity assessment efficiency. Manufacturers expressed uncertainty around clinical evidence and documentation requirements, which may hinder innovation.
For more details, visit the official survey findings: MedTech Europe 2024 Regulatory Survey
On 28 January 2025, the MDCG released updates to the European Medical Device Nomenclature (EMDN) codes. This includes four key documents: the updated MDCG 2025-1 EMDN Ad hoc procedure, the MDCG 2025-2 summary of 2024 submissions, the MDCG 2025-3 version history, and the revised MDCG 2021-12 FAQ on EMDN. The revisions aim to clarify the process for submitting ad-hoc updates to EMDN codes and summarize the results of the public consultation on the 2024 submissions. The updates also revise the FAQs to align with the newly published form for ad-hoc requests. Manufacturers should review these changes as they may impact their classification codes, technical documentation, and EUDAMED registrations. The updated codes, including new, split, or obsolete codes, must be reflected in relevant documents and audits, as outlined in the revised guidance.
For more details, visit the official documents:
Learn more about EU Medical Device Registration.
On 30 January 2025, Swissmedic introduced a new form for the Notification of Safety Measures for Medical Devices (MD) and In-Vitro Diagnostics (IVD). This form is intended for notifying the premature termination, interruption, or temporary halt of a clinical trial for safety reasons, in accordance with Articles 36(4) and 38 of the Ordinance on Clinical Trials of Medical Devices (ClinO-MD). It can also be used for notifying safety and protective measures under Article 34 of the ClinO-MD. The form should be used in conjunction with the guidance documents "BW600_00_015e_MB for clinical investigations of medical devices" and "BW600_00_016e_MB for interventional performance studies of IVDs," which provide detailed information on the approval process, reporting requirements, and surveillance of clinical trials by Swissmedic.
For more information, visit the official document: Notification of Safety Measures MD IVD
On 24 January 2025, Swissmedic released Version 3.4 of their guidance document for economic operators regarding incident reporting. This update incorporates changes based on the revision of MDCG 2023-3 and extends its applicability to products under the In-vitro Diagnostic Ordinance (IvDO). While the update does not introduce significant changes to timelines, it includes minor adjustments to terminology and Swiss legislation (IvDO, MedDO). The guidance emphasizes the importance of reporting all serious incidents involving devices supplied in Switzerland or Liechtenstein under Customs Treaty law.
For more details, visit the official document: Swissmedic Incident Reporting Guidance
On 17 January 2025, Swissmedic released Version 2.1 of their FAQ guidance document regarding in vitro diagnostic (IVD) medical device notifications. This updated document provides clarity on the notification requirements for devices under the Customs Treaty between Switzerland and Liechtenstein, in compliance with the Medical Device Ordinance (MedDO) and the In-vitro Diagnostic Device Ordinance (IvDO). The updated FAQ applies to all medical devices placed or made available on the market or put into service within the territories of Switzerland and Liechtenstein.
On 20 January 2025, Swissmedic released two new forms for submissions related to modifications, notifications, and reports for clinical investigations and interventional performance studies of medical devices (MDs) and in vitro diagnostic devices (IVDs). These forms also apply to combined studies involving medicinal products or advanced therapy medicinal products (ATMPs) alongside MDs or IVDs. The forms are required for substantial modifications according to Articles 15 and 20 of the Clinical Trials Ordinance (ClinO-SR) and must be used for all clinical investigations, in line with Good Study Practice (GSP) requirements. Manufacturers and sponsors should use these forms for clinical investigations or studies that require approval from the Ethics Committee and Swissmedic. Non-CE marked devices will need to submit additional documentation, including the revised GSPR checklist and applicable standards.
For more details, visit the official documents:
Learn more about Switzerland Medical Device Registration.
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