What is the EU MDR simplification proposal?

On December 12, 2025, the European Commission published a proposal to significantly revise EU MDR (2017/745) and IVDR (2017/746). Key changes include removing the 5-year certificate validity cap, standardising Notified Body timelines, reclassifying software/AI devices to lower-risk defaults, and expanding in-house device exemptions for hospitals. Adoption is expected Summer–Late 2026, though the regulation will not take effect immediately upon adoption.

Do I need to update my tender compliance documents now?

Yes — partially. EUDAMED transparency obligations started May 28, 2026 and require all device models to be registered before market placement. Separately, the simplification proposal is still in legislative procedure. But suppliers tendering in EU hospitals today should audit existing documentation against current MDR requirements while preparing for the changes coming with adoption. Waiting until the final text is published risks a documentation gap when fast-moving procurement cycles hit.

Does the MDR simplification change how my Notified Body certificate appears in tenders?

Potentially yes. The proposal removes the 5-year certificate validity cap, replacing it with periodic review. This means certificates issued after the new regulation takes effect will not carry a fixed expiry date in the traditional sense. Procurement systems that validate certificates by checking expiry dates may need to handle this differently. Until the final text is adopted and implemented, your existing MDR certificates with fixed expiry dates remain valid and compliant.

What does the software/SaMD reclassification mean for tenders?

Under the proposal, software generating clinical outputs would default to Class I (self-declared conformity) unless used in serious or critical clinical situations. This means many SaMD products currently requiring a Notified Body for Class IIa conformity would be able to use manufacturer self-declaration instead — reducing the compliance documentation burden in tenders. Class IIb and III SaMD products remain subject to full Notified Body review.

What EUDAMED requirements are already in force in 2026?

As of May 28, 2026, manufacturers must register all new device models in EUDAMED before placing them on the EU market. Transparency obligations under both MDR and IVDR are now in mandatory-use phase for the actor registration, UDI/device registration, and certificate modules. Tender submissions increasingly require proof of EUDAMED registration as a pass/fail criterion. Devices without valid EUDAMED registration are at risk of procurement rejection in EU hospital tenders.

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EU MDR/IVDR Simplification 2026: What Changes for Your Tender Compliance Documents

3 juin 2026

The European Commission's December 2025 proposal to simplify EU MDR (2017/745) and IVDR (2017/746) is the most significant planned revision to the EU medical device regulatory framework since the original MDR replaced the MDD. For medical device suppliers responding to hospital tenders across the EU, the implications extend well beyond regulatory compliance — they reach directly into what your tender documentation must contain, how Notified Body certificates are interpreted, and how EUDAMED registration is verified at bid evaluation.

This guide covers what is changing, what is already in effect, and specifically what your tender compliance documents need to reflect as adoption approaches.

What the EU MDR/IVDR simplification proposal changes

The European Commission's proposal targets five structural pain points that have accumulated since MDR/IVDR became fully applicable:

1. Certificate validity: removing the 5-year cap

Under current MDR/IVDR, Notified Body certificates expire after a maximum of five years. The proposal removes this fixed validity cap. Instead, certificates would be subject to periodic review by the Notified Body during their lifetime — with no automatic expiry date. This has direct tender implications:

Procurement systems that validate certificate validity by checking expiry dates will need to adapt. A certificate issued under the new framework will not carry a "valid until" date in the traditional sense.
In the interim (current certificates issued under existing MDR rules), your certificates retain fixed expiry dates and continue to be evaluated by tender procurement systems as before.
Suppliers should prepare for a period of inconsistency: some tenders will have updated their certificate verification criteria to reflect the new framework; others will not. Having both a clear certificate lineage document and direct EUDAMED verification available will prevent procurement delays.

2. Notified Body standardisation: predictable timelines

One of the most operationally significant changes is the introduction of EU-wide maximum timelines for Notified Body procedures:

Procedure	Maximum timeline
Application review	30 days
QMS audit	120 days
Product verification (technical documentation review)	90 days
Certificate issuance	15 days after audit completion

Currently, Notified Body timelines vary widely — and extended delays (6–18 months for initial certifications) have been a major market access obstacle. Standardised timelines mean certification planning for new devices or re-certifications becomes more predictable. For tender teams, this matters for planning: a new product's EU market eligibility (and therefore tender eligibility) can be estimated more reliably once the new framework applies.

3. Software and AI device reclassification

The proposal introduces a significant change for Software as a Medical Device (SaMD) and AI-enabled devices:

Software generating outputs for clinical benefit would default to Class I (self-declared conformity, no Notified Body required), with escalation to higher classes only where the software is used in serious or critical clinical situations.
AI medical devices would not need to separately comply with the EU AI Act in addition to MDR/IVDR — AI-specific requirements will instead be integrated directly into the device regulatory framework through Delegated Acts.

Tender compliance implications: SaMD products that currently carry Class IIa NB certificates (because Rule 11 under current MDR requires it for many clinical decision-support applications) may be able to use self-declaration under the new framework. This would reduce the compliance documentation burden — but only after the regulation is adopted, Notified Bodies have implemented the new classification rules, and procurement authorities have updated their verification requirements. Until then, your existing NB certification remains the correct documentation for EU hospital tenders.

4. Orphan device provisions

Manufacturers of orphan devices — low-volume products that were previously lawfully marketed but lack a viable commercial path to full MDR conformity assessment — would be permitted to continue marketing under defined conditions without completing a new full conformity assessment. For tender teams, this means some niche or legacy products previously excluded from procurement eligibility may re-enter bid coverage.

5. In-house device flexibility for hospitals

The proposal introduces more flexibility for EU health institutions that manufacture and use devices in-house (Article 5(5) devices). Hospitals would be permitted to transfer in-house devices to other health institutions in the interest of patient safety or public health, and for emergency response. This primarily affects hospital-side procurement design rather than supplier tender compliance directly, but it expands the range of procurement scenarios in which in-house-manufactured devices appear alongside commercially supplied products.

What is already in force: EUDAMED mandatory obligations from May 28, 2026

Separate from the simplification proposal (which is still in legislative procedure), new EUDAMED transparency obligations became mandatory on May 28, 2026. These are not proposals — they are in effect now:

All new device models must be registered in EUDAMED before being placed on the EU market. This is no longer a transitional provision — it is a hard requirement for new devices.
The actor registration module, UDI/device registration module, and Notified Body/certificate module are all in mandatory-use phase.
Vigilance and post-market surveillance modules are being phased in during 2026.

In EU hospital tenders, EUDAMED registration is increasingly treated as a pass/fail criterion. Procurement officers verify registration status directly in EUDAMED before evaluating technical specifications. A device that is clinically excellent but lacks EUDAMED registration will be disqualified from evaluation in an increasing number of EU tenders.

What to update in your tender compliance documents

Given the combination of what is already in force and what is approaching with the simplification proposal, here is a practical checklist for your EU tender documentation:

Immediately (what is in force now)

EUDAMED registration confirmation — add a EUDAMED basic UDI-DI reference to your standard tender compliance document. Procurement teams are increasingly requesting this, and having it pre-prepared avoids clarification rounds that can delay submission.
MDR Declaration of Conformity audit — verify that your DoC references MDR 2017/745 (not MDD 93/42/EEC). Verify Annex references are correct for your device class and conformity assessment route. Any MDD-era references are a red flag in 2026 EU hospital tenders.
Notified Body certificate currency — confirm your NB certificate validity dates extend beyond the tender contract period. Many EU hospital framework contracts run 2–4 years; a certificate expiring mid-contract can trigger disqualification at contract delivery stage even if you were compliant at submission.
UDI consistency — verify that the UDI-DI listed in your EUDAMED registration matches the UDI printed on your device label and the UDI referenced in your technical documentation. Inconsistencies between these sources are a common rejection trigger in Belgian, German, and French hospital tenders.

In preparation for simplification adoption (expected Summer–Late 2026)

Track your certificate type — if your certificates are renewed or issued after the new regulation takes effect, prepare to document them as subject to periodic review rather than fixed-expiry. Brief your tender team on how to present this to procurement authorities that are unfamiliar with the new framework.
SaMD classification review — if you supply software-based devices currently classified as IIa under Rule 11, review whether the proposed reclassification would affect your conformity assessment route. Do not change your classification before the regulation is adopted and implemented, but prepare the internal analysis now so you can respond quickly once the text is final.
Notified Body planning — if you have pending NB applications or re-certifications, the standardised timelines (30/120/90/15 days) will allow more reliable scheduling. Plan tender eligibility dates for new products around these timelines once the regulation is in force.

Timeline: where the simplification proposal stands

Date	Event
December 12, 2025	European Commission publishes simplification proposal
May 6, 2026	Public consultation period closes
May 28, 2026	EUDAMED transparency obligations enter mandatory-use phase
Summer 2026 (earliest)	Possible adoption of simplification regulation (legislative procedure)
Late 2026–Early 2027	More likely adoption timeline given EU legislative process
TBD after adoption	Transitional period before new certificate rules take effect

The consultation closed May 6, 2026. The European Parliament and Council are now reviewing the proposal in co-decision procedure. Given the complexity of the changes and the number of stakeholder interests involved, the realistic adoption timeline is late 2026 or early 2027, with transitional provisions likely extending the practical impact further. However, EUDAMED mandatory-use obligations and current MDR requirements apply in full right now.

How MedStrato handles EU MDR compliance in tender responses

MedStrato's compliance engine cross-references your product portfolio against EUDAMED registration status, Notified Body certificate validity, UDI assignments, and country-specific tender compliance requirements in real time. When a new EU hospital tender arrives, the system automatically flags:

Products with EUDAMED registration gaps
NB certificates expiring within the contract period
UDI discrepancies between certificate data and EUDAMED records
Tenders requiring SSCP (Summary of Safety and Clinical Performance) for Class III or implantable devices
DoC references that still cite MDD rather than MDR

As the simplification regulation is adopted and its requirements take effect, the compliance engine will be updated to reflect the new certificate structures and classification rules — so your tender compliance posture adapts without requiring manual regulatory monitoring from your bid team.

Book a demo to see how MedStrato tracks EU MDR compliance in real time across your full product portfolio, or explore our EU MDR tender requirements checklist for the complete current-state compliance document list.