Practical articles and resources for regulated teams working on CSV/CSA, validation, QMS and audit readiness.
SQC
13 August 2026
The EU’s Proposed MDR and IVDR Simplification: What Could Change—and What Has Not Changed Yet
The European Commission proposed a targeted revision of the MDR and IVDR on 16 December 2025. Its objectives are to reduce disproportionate burden, improve regulatory predictability, support innovation and protect device availability without lowering patient-safety standards.
The proposal is not yet law. In August 2026, it remains within the EU ordinary legislative procedure. The Council is examining the text, while Parliament develops its position before negotiations on final legislation.
Manufacturers should therefore understand the direction of travel without implementing unconfirmed requirements prematurely.
What could change?
More proportionate conformity assessment
The Commission wants notified-body involvement, surveillance and audit frequency to reflect actual device risk more closely. The proposal also seeks more predictable and cost-efficient certification processes and greater consistency between notified bodies.
These changes could reduce unnecessary work for established products, but the detailed controls remain under negotiation. Council discussions have already highlighted the need to balance simplification against strong pre-market assessment and post-market monitoring.
Recognition of well-established technologies
A proposed definition of “well-established technology device” would support more proportionate requirements for devices with mature technology and an established safety history. The concept could affect clinical evidence and conformity-assessment expectations for qualifying products.
Member States broadly support the direction but have requested clearer eligibility criteria. Manufacturers should not currently classify their products as well-established technology devices or reduce evidence based on the proposal alone.
Adapted routes for innovative and specialist devices
The proposal develops pathways for breakthrough and orphan devices, supported by expert advice and more coordinated regulatory processes. Some Member States have suggested extending adapted approaches to other categories, including paediatric devices.
The proposed role of expert panels would also broaden, while the European Medicines Agency could provide scientific, technical and administrative support. The division of responsibilities between EMA, MDCG and national authorities remains under discussion.
Changes to reporting and post-market activities
The Commission proposes more risk-proportionate manufacturer reporting, post-market surveillance and evidence requirements. This could reduce the frequency or extent of certain recurring activities where risk and device history justify it.
However, simplification does not mean removal of lifecycle oversight. Council discussions emphasise that any reduction in pre-market or routine burden must remain supported by effective post-market monitoring.
Notified-body fees and oversight
The proposal seeks stronger coordination of notified-body oversight, mechanisms for resolving certain disputes and measures intended to reduce costs for micro and small manufacturers.
These provisions remain contested. Member States have questioned how fee reductions might affect notified-body sustainability and how responsibilities within joint assessment and dispute processes should be divided.
What has not changed yet?
The existing MDR and IVDR remain fully applicable. Manufacturers must continue meeting current requirements for:
conformity assessment and CE marking;
quality management systems;
technical documentation and clinical or performance evaluation;
risk management;
post-market surveillance, vigilance and PMCF or PMPF;
UDI and EUDAMED registration;
economic-operator responsibilities; and
existing transitional provisions and deadlines.
A proposal, progress report or political statement does not amend an approved procedure, notified-body contract or regulatory obligation. Changes become binding only after the final regulation is adopted, published and reaches its applicable date.
What should QA and RA teams do now?
Organisations should monitor the legislative procedure, identify provisions relevant to their portfolios and maintain a controlled regulatory impact assessment. Potential impacts can be mapped against certification, clinical evidence, PMS, notified-body management, software, AI and SME status.
Procedures should not be rewritten around draft wording. Instead, manufacturers can improve data quality, clarify device groupings and build proportionate, risk-based QMS processes that can accommodate future amendments through change control.
The message is simple: prepare for reform, but continue complying with the law in force today.
Sparko Quality Consulting supports regulatory impact assessments, MDR and IVDR gap reviews, QMS remediation and implementation planning. Contact sqc@sparkoqualityconsulting.co.uk to discuss practical support.
SQC
13 August 2026
Can a Distributor Assign Its Own UDI-DI? MDCG 2026-5 Explained
MDCG 2026-5, published in July 2026, addresses distributors obtaining UDI-DIs in their own names for devices sold under distributor brands.
The conclusion is clear: a device marketed under two different trade names may appropriately have two UDI-DIs, but both must be assigned by and linked to the legal manufacturer. The distributor cannot independently assign a UDI to the device.
Why was clarification needed?
Some distributors sell a manufacturer's device under their own branding while the manufacturer remains identified on the label and retains regulatory responsibility. Article 16(1)(a) MDR or IVDR allows this arrangement.
Some distributors obtained UDI-DI codes directly from EU issuing entities, linking the branded code to themselves rather than to the manufacturer. The manufacturer might then register both UDI-DIs beneath the relevant Basic UDI-DI in EUDAMED.
MDCG rejected this interpretation. Under the MDR and IVDR, a UDI-DI is specific to a manufacturer and a device. The manufacturer must assign and maintain unique UDIs, and only the manufacturer may place the UDI on the device or its packaging.
Can distributor branding require another UDI-DI?
Yes. MDCG 2026-5 recognises that the same device made available under two different trade names may appropriately require two different UDI-DIs.
However, different branding does not transfer UDI responsibility. Both UDI-DIs must be obtained for, assigned by and linked to the legal manufacturer in the issuing entity's records. Both device records must also be registered in EUDAMED by the manufacturer.
The distributor's commercial relationship with the product does not make it the manufacturer for UDI purposes where the original manufacturer remains identified and legally responsible.
Can a distributor perform the practical work?
A manufacturer may contract a distributor, consultant or other third party to undertake operational activities, such as communicating with an issuing entity or preparing UDI data.
Delegating work is not the same as transferring responsibility. The codes must remain linked to the manufacturer, and the manufacturer retains ultimate legal liability for UDI compliance. Authorised representatives, importers and distributors cannot become the assigning entity merely because they complete administrative steps.
This distinction should be reflected in contracts, procedures, account permissions and approval records. The manufacturer should control the decision to create a UDI-DI and verify the resulting issuing-entity and EUDAMED records.
What should manufacturers and distributors review?
Organisations using private-label or distributor-brand arrangements should perform a documented review covering:
every device marketed under more than one trade name;
which legal entity obtained each UDI-DI;
the entity to which each code is linked in the issuing entity's records;
whether the legal manufacturer is correctly identified on labels and documentation;
whether EUDAMED records sit under the manufacturer's actor registration;
whether Basic UDI-DI grouping remains appropriate; and
whether contracts clearly separate operational tasks from legal responsibility.
Where a distributor has obtained codes in its own name, the manufacturer should engage the relevant issuing entity to determine the controlled correction route. Associated labels, EUDAMED data, internal master data and contractual arrangements should then be assessed through change control.
Companies should not simply delete, replace or reuse UDI-DIs without assessing traceability, existing stock, regulatory records and the issuing entity's requirements.
Building audit-ready UDI controls
A robust UDI process should identify who requests, assigns, verifies, approves and registers each code. Evidence should connect the issuing-entity record, device master data, label, declaration of conformity, technical documentation and EUDAMED submission.
Periodic reviews should include distributor-branded variants, because commercial branding decisions can create regulatory data consequences even when the physical device remains unchanged.
MDCG 2026-5 does not prohibit distributors from supporting UDI administration. It confirms that the legal manufacturer must remain at the centre of the UDI record and cannot contract away its regulatory responsibility.
Sparko Quality Consulting supports UDI governance reviews, EUDAMED data reconciliation, responsibility matrices, procedures and remediation of inconsistent device records. Contact sqc@sparkoqualityconsulting.co.uk to discuss practical support.
SQC
13 August 2026
EUDAMED Is Now Mandatory: What Medical Device Manufacturers Must Do in 2026
After years of voluntary use and delayed implementation, key EUDAMED modules became mandatory on 28 May 2026. Manufacturers, authorised representatives and importers must now ensure that applicable actor and device information is registered, accurate and maintained as controlled regulatory data.
Four modules are mandatory: Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, and Market Surveillance. The final two modules, Vigilance and Post-Market Surveillance and Clinical Investigations and Performance Studies, are not yet mandatory. Until the Vigilance module becomes available, organisations must continue using the applicable national reporting routes.
Who must register as an actor?
EU and non-EU manufacturers, authorised representatives, importers and system or procedure pack producers must register before placing applicable products on the EU market. Following competent-authority approval, EUDAMED generates an Actor ID or Single Registration Number.
Non-EU manufacturers must have an active EU authorised representative and submit a mandate summary. Individual users must also obtain appropriate access under the registered actor.
Distributors are not required to register simply because they distribute devices, although separate national registration obligations may apply.
Which devices must be registered?
The deadline depends on when the device was first placed on the market and whether further units will be supplied.
For a Regulation device whose first unit is placed on the EU market on or after 28 May 2026, registration must be completed before that first unit is placed on the market. The November transition does not apply to newly introduced devices or devices requiring a new UDI-DI.
Where a Regulation or legacy device was already placed on the market before 28 May 2026 and additional units will be supplied afterwards, registration must be completed by 28 November 2026.
A device that is no longer placed on the market after 28 May 2026 does not generally require registration solely because older units remain in the supply chain. Registration may, however, become necessary later if a reportable post-market or vigilance action must be performed in EUDAMED.
Custom-made, investigational and performance-study devices are not registered as standard UDI/Device records. Systems and procedure packs should be assessed under their specific Article 22 MDR requirements.
EUDAMED registration is completed at device-identifier level, not separately for every unit, lot or serial number. Production identifiers therefore do not create individual device registrations.
Treat EUDAMED as a QMS process
A successful submission is not automatically an accurate or audit-ready record. Before registration, manufacturers should reconcile EUDAMED data against controlled sources, including declarations of conformity, certificates, labels, instructions for use, UDI records, technical documentation, classification, EMDN codes and authorised-representative information.
The QMS should define who prepares, verifies, approves and submits information. Significant fields should receive an independent check against approved source documents. Evidence of submission and approval should be retained.
Change control should also assess whether EUDAMED requires updating following a new UDI-DI, certificate change, authorised-representative change, product discontinuation, classification change or correction to existing data. User access should be reviewed periodically, and organisations should avoid relying on one trained user.
Manufacturers should verify how submitted records appear on the public database. A device may not become publicly visible until the notified body has registered and linked the relevant certificate. Investigate the record and certificate status before assuming submission failed or creating a duplicate entry.
Common weaknesses include applying the November deadline to new devices, assuming data entered during voluntary use remains correct, registering lots as separate devices, using uncontrolled spreadsheets as the source of truth and waiting for all six modules before acting.
What should manufacturers do now?
Manufacturers should confirm actor registrations and access, create a complete EU portfolio inventory, assign every device a registration route and deadline, prioritise post-May 2026 launches, and complete applicable transitional registrations before 28 November 2026. Existing records should be checked against controlled documentation, with discrepancies investigated and corrected.
EUDAMED should not be treated as a one-off data-entry project. Integrating it into product launch, change control, post-market surveillance and regulatory record management creates clearer ownership and more defensible audit evidence.
Sparko Quality Consulting supports EUDAMED readiness reviews Contact sqc@sparkoqualityconsulting.co.uk to discuss practical support.
Read more