The week of 25–31 May 2026 brought several noteworthy regulatory developments in the medical device and in vitro diagnostic (IVD) sectors. In Europe, the main milestone was the mandatory use of the first four EUDAMED modules. In the United States, the FDA published new safety communications and updated its recognized consensus standards database.
EUDAMED: First Four Modules Become Mandatory from 28 May 2026
As of 28 May 2026, the use of the first four EUDAMED modules has become mandatory under the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
The modules concerned are:
- Actor Registration;
- UDI/Device Registration;
- Notified Bodies and Certificates;
- Market Surveillance.
The milestone follows the European Commission’s publication of the notice confirming that the relevant EUDAMED functionalities are fully operational and establishing the associated transition timeline.
Source: European Commission (DG SANTE)
Reference: The EUDAMED four first modules will be mandatory to use as from 28 May 2026
Team-NB Publishes Legal Expert Opinion on the Proposed “MDR Article 50” Approach
On 26 May 2026, Team-NB, the European association of notified bodies, published a legal expert opinion addressing an approach referred to Article 50 in the context of ongoing discussions on potential revisions to Regulation (EU) 2017/745 (MDR).
According to Team-NB, the publication represents a legal analysis prepared by external experts and does not constitute an official position of European institutions or regulatory authorities.
Source: Team-NB
Reference: Legal Expert Opinion on MDR Article 50
FDA Issues Early Alert on Certain IV Tubing Sets
The U.S. Food and Drug Administration (FDA) published an Early Alert concerning certain IV tubing sets manufactured by ICU Medical.
The communication, current as of 27 May 2026, describes reports involving discoloration and visible particulate matter referred to as “black specks.” The FDA stated that the scope of the issue and the number of affected units remain under review.
Source: FDA – Center for Devices and Radiological Health (CDRH)
Reference: Early Alert: IV Tubing Set Issue from ICU Medical
FDA Updates Medical Device Safety Notices and Recall Listings
During the week, the FDA updated its Medical Device Safety page with several new recall, correction, and safety alert postings.
Among the items listed were:
- a recall involving a Medline manifold, posted on 26 May 2026;
- a correction related to a pediatric care bed, posted on 29 May 2026;
- the Early Alert concerning ICU Medical IV tubing sets, posted on 27 May 2026.
These notices were included in the FDA’s recent medical device recalls and early alerts updates.
Source: FDA – Medical Device Safety
Reference: Recent Medical Device Recalls and Early Alerts
FDA Recognizes ISO 10993-1:2025
On 25 May 2026, the FDA added ISO 10993-1:2025 (6th Edition) to its Recognized Consensus Standards Database.
ISO 10993-1 provides the framework for the biological evaluation of medical devices and is widely used in the assessment of biocompatibility throughout the medical device industry.
The database entry is accompanied by a supplementary information sheet published by the Agency.
Source: FDA – Recognized Consensus Standards Database
Reference: ISO 10993-1:2025 (Date of Entry: 25 May 2026)
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