EUDAMED Fully Functional EU Sets 2026 Deadline

 

On 27 November 2025, European Commission formally declared that four core modules of EUDAMED — Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance have met their functional specifications. As a result, a six‑month transition period begins, making these modules mandatory from 28 May 2026.

Why This Is a Big Deal

End to “voluntary use” era: Until now, many companies used EUDAMED voluntarily or relied on national registries. From May 2026 onward, all responsible economic operators (manufacturers, authorised representatives, importers, Notified Bodies) must register and use these modules under MDR 2017/745 (and where applicable, IVDR 2017/746).

Broader traceability and transparency: EUDAMED becomes the centralised system for device registration, UDI assignment, certificates, and market‑surveillance oversight. This strengthens regulatory oversight and harmonises device data across the EU.

Fixed deadlines for legacy and new devices: New MDR/IVDR devices placed on the EU market after 28 May 2026 must be registered in EUDAMED beforehand. Legacy devices (already on the market) must be registered by 28 November 2026.

Certificate and Notified‑Body data compliance window: For devices certified prior to mandatory EUDAMED use, Notified Bodies must upload certificates and associated documentation (e.g. Master SSPs) extended until 28 May 2027.

Key Risks & Challenges for Manufacturers / IVD Companies

Compliance burden & resource readiness: Many companies (especially smaller ones) will need to rapidly audit their internal device registries, generate UDI codes if not yet assigned, ensure valid certificates, and map their supply‑chain and post‑market surveillance data to comply with EUDAMED.

Legacy device catch‑up pressure: For devices already on the market, failure to register by the November 2026 deadline may risk non-compliance potentially leading to market access issues or regulatory enforcement.

Notified Bodies / certification backlog risk: Notified Bodies must integrate into EUDAMED and upload all pre-existing certificates but given historically slow timelines for full EUDAMED deployment (especially clinical & vigilance modules), there may be backlog or resource constraints.

What This Means for Non‑EU Manufacturers & Global Regulatory Strategies (e.g. India‑based companies)

Global supply‑chain alignment required: Manufacturers outside the EU including India targeting EU markets must align with EUDAMED timelines. This increases the need for robust regulatory planning and early data generation.

Proactive MDR/IVDR dossier alignment becomes critical: Device dossiers for EU submission must now be conceived with EUDAMED registration in mind including UDI allocation, certificate uploading, and readiness for post‑market surveillance obligations.

Read more in detail here: EU Confirms EUDAMED Functionality With May 2026 Deadline Set

Comments

Post a Comment

Popular posts from this blog

Safety Reporting in the EU - EudraVigilance to EVDAS & SPOR

Image
  Safety Reporting in the EU With safety reporting in the European Union (EU) entering a new era of digital integration and oversight, pharmacovigilance systems have become more connected, data-driven, and strategically central to  regulatory compliance . What once revolved around manual case handling and isolated national databases has transformed into a highly interconnected pharmacovigilance network. This shift is not only redefining how  Marketing Authorisation Holders  (MAHs) manage  Individual Case Safety Reports  (ICSRs), but it’s also reshaping their overall safety strategy. The regulatory landscape has gone far beyond the central  EudraVigilance  system. Tools like EVDAS (EudraVigilance Data Analysis System) and SPOR (Substance, Product, Organisation, and Referential data services) have become central to pharmacovigilance compliance. However, with increased automation, transparency, and interconnectivity come greater complexity and respon...
Read more

Risk Management in Regulatory Affairs: Mitigating Compliance Risks

Image
Pharmaceutical companies face significant challenges in navigating a stringent and constantly evolving regulatory environment, coupled with technological advancements and global economic considerations. Assessing and managing risks is vital throughout the entire life cycle of a pharmaceutical product, from research and clinical testing to manufacturing and distribution. Organizations must demonstrate to regulatory authorities that they have a well-documented plan to identify, measure, control, and monitor the various risks. The pharmaceutical industry is highly regulated for good reason, given the critical importance of safety, efficacy, and the impact that medicines and treatments can have on patient’s lives. Regulatory scrutiny spans various aspects of pharmaceutical operations, including sales and marketing, drug price reporting, patient privacy, clinical trials and procedures, preclinical work and testing, and manufacturing. Consequently, ensuring compliance with regulatory affairs...
Read more

Customer Due Diligence: Meeting Regulatory Expectations

Image
In today's business landscape, regulatory compliance is a cornerstone of trust and integrity. Nowhere is this more evident than in the realm of customer due diligence (CDD). Financial institutions, businesses dealing with high-value transactions, and even online platforms must adhere to stringent CDD requirements to mitigate risks associated with money laundering, terrorism financing, and other illicit activities. Meeting regulatory expectations in CDD is not just about ticking boxes; it's about safeguarding against financial crime while fostering trust with customers. Let's delve into how businesses can navigate this complex landscape effectively. Understanding Customer Due Diligence Customer due diligence refers to the process of verifying the identity of customers, assessing the risks they pose, and understanding the nature of their transactions. It involves collecting relevant information about customers, such as their identity, address, and source of funds, to ensure c...
Read more