Europe, Jan 17 2025 – The European Medicines Agency (EMA) published its latest post-authorisation procedural advice (Revision 116) on January 15, 2026. While primarily focused on medicinal products, this guidance significantly impacts medical device manufacturers, particularly those producing integral devices for combination products or medicinal products with ancillary device components.
The new guidance introduces critical technical requirements and procedural changes that could act as “validation blockers” if manufacturers are not fully prepared.
MANDATORY OMS REGISTRATION: THE "VALIDATION BLOCKER"
One of the most critical updates for manufacturers is the mandatory use of the Organisation Management Service (OMS).
- The Requirement: As of 2026, registration of all sites and organisations in the OMS is mandatory prior to submitting regulatory applications (e.g., adding a manufacturing site or transferring an authorisation).
- The Risk: The EMA has identified missing OMS registration as a “validation blocking issue”. This means any submission involving a device manufacturing site not registered in the OMS will be stalled before the procedure even begins.
- Action Needed: Device manufacturers must ensure their unique identifiers (ORG_ID and LOC_ID) are active and accurate in the SPOR/OMS database.
NAVIGATING THE REVISED VARIATIONS FRAMEWORK
The European Commission adopted new guidelines for post-authorisation variations that became applicable on January 15, 2026.
- Type IB Variations (“Tell, Wait, and Do”): Minor changes to device components that do not affect the drug’s safety or efficacy now follow a strict 30-day “Tell, Wait, and Do” procedure. Manufacturers must notify the EMA, wait 30 days, and only proceed if no objections are raised.
- Type II Variations (Major Changes): Changes that significantly impact the quality, safety, or efficacy of the combination product such as redesigning a needle guard or changing primary device materials require formal approval before implementation.
- Grouped Variations: To improve efficiency, manufacturers can now group related variations (e.g., a quality change in the device and a related update to the drug’s labeling) into a single submission.
THE END OF IRISH LANGUAGE DEROGATION
The expiration of the Irish language derogation means Irish is now an authentic language for all Commission decisions on marketing authorisations.
- Labeling Impact: Product information, including instructions for integral devices, must now be translated into Irish alongside other official EU languages for procedures like referrals and Post-Authorisation Safety Studies (PASS).
- Waivers: Marketing Authorisation Holders (MAHs) established in Ireland can request a language waiver to keep English as the authentic language for their specific product, but this does not apply to decisions addressed to all Member States.
KEY PROCEDURAL IMPACTS AT A GLANCE
Change Category | Impact on Device Manufacturers | Compliance Deadline |
New Site Addition | Mandatory OMS Registration required before filing. | Immediate (Jan 2026) |
Technical Changes | Revised Variation Guidelines apply to all new filings. | 15 January 2026 |
Product Labeling | Irish language translations required for specific procedures. | Active from Jan 2022/2026 |
New Pack Sizes | Triggers a new EU sub-number for the presentation. | Case-by-case |
WHAT SHOULD MANUFACTURERS DO NOW?
Device manufacturers are encouraged to coordinate closely with their pharmaceutical partners to ensure that all manufacturing and sterilization sites are correctly captured in the EMA SPOR system. Failure to align these records will lead to significant delays in product lifecycle management and market availability.