MDD to MDR transition eligibility and next steps

Start with the records that establish your device's position, then plan the work needed for MDR certification. A sound technical file cannot repair a missed historical eligibility condition, and an eligible device can still need substantial clinical or technical work before it meets MDR requirements.

This guide covers EU medical devices transitioning from the Medical Devices Directive, or MDD, and relevant Active Implantable Medical Devices Directive, or AIMDD, certificates. It does not apply the same dates to IVDs, UKCA certification or every custom-made device. The framework below follows the Commission-hosted transition guidance. Your device-specific decision needs the applicable Article 120 text, certificate history and subsequent changes considered together.

Which transition deadline applies to your device?

For eligible certificate-covered devices, the framework distinguishes a 31 December 2027 endpoint from a 31 December 2028 endpoint. The MDR classification matters when selecting that date. Do not copy the old MDD class into a transition spreadsheet without checking the MDR classification rationale.

MDCG 2022-4 Rev. 2 sets out the following categories for Directive-certified devices, subject to the relevant conditions.

The class IIb implantable exceptions are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. The exception list does not move a class III device into the 2028 category merely because its name resembles an item on that list.

There is also a separate Article 120 route for certain devices that did not require notified-body involvement under MDD but do require it under MDR. Do not force these devices into the certificate table. They need a separate check of the pre-26 May 2021 declaration, MDR classification and applicable transition conditions. The surveillance guidance linked above expressly excludes that group from its scope, so it cannot establish that branch of your decision by itself.

Work through classification before choosing a date

Consider an illustrative portfolio with a class III implantable device, a class IIb implantable plate and a class IIa non-implantable device. These are invented examples, not customer cases, and the classifications are assumptions for the exercise rather than conclusions about real products.

The class III device points to 2027. The class IIb plate points to 2028 because plates appear in the exception list. The class IIa device also points to 2028. None of those outcomes establishes eligibility until the relevant certificate, application, agreement and ongoing conditions have been checked.

Now suppose the plate's classification rationale actually supports class III. Its product name does not preserve the later date. The owner must revisit the endpoint and planning assumptions, not simply keep the portfolio's original 2028 target.

Record the classification rule, rationale version and device configuration beside the date. That makes the decision reviewable when a claim, design or portfolio boundary changes.

What proves MDD to MDR transition eligibility?

Eligibility rests on historical gates and continuing conditions. A historical gate asks what existed by a specified date. A continuing condition asks whether the device still qualifies today. Treating both as a single green status hides the difference between a missing record and a condition that was never met.

For the Directive-certified devices it covers, MDCG 2022-4 Rev. 2 describes continued Directive compliance and checks relating to significant changes and unacceptable risk. These need consideration alongside the full statutory conditions, which the guidance does not reproduce exhaustively. It also identifies the QMS, application and written-agreement milestones associated with the extended transition.

Your quality management system needed to be in place in accordance with Article 10(9) by 26 May 2024. The formal application needed to be lodged by 26 May 2024, followed by a written agreement by 26 September 2024. Those dates are historical conditions, not tasks that a transition plan can move into a future quarter.

A QMS certificate, quotation or introductory email does not independently demonstrate all of these conditions. Nor does the fact that your notified body is reviewing a dossier now establish what happened in May 2024. Inspect the dated records and their device scope.

Build the evidence record around the device

Use one record per device or clearly justified family. Where variants share a row, explain why the same evidence covers them. Your working record should connect the marketed identifiers to the names in the Directive certificate, application and written agreement, including any documented relationship to a device intended to substitute for the legacy device.

This is an evidence-organising tool, not a substitute for a regulatory determination. Its value is that another qualified person can follow the conclusion back to dated records without relying on the person who remembers the original application.

A populated example exposes the real uncertainty

The following invented example is illustrative. A manufacturer markets a family called Orion, with variants O1 and O2. The internal assessment assumes a class IIa device and otherwise relevant Directive certificate coverage. Those assumptions need verification in a real assessment.

The correct result is not a single green row for Orion. O1 and O2 need separate conclusions until the agreement scope is resolved. A newly signed schedule should not be treated as proof that O2 was covered in September 2024.

Keep three possible conclusions in your record. Evidence supports the proposed eligibility basis, evidence is incomplete, or a condition appears unmet. These labels make uncertainty visible without turning every missing attachment into a finding of ineligibility.

Does an expired printed certificate settle the question?

A printed expiry date alone does not settle transition eligibility. The extension framework includes certificate-validity provisions, and the history of a certificate can change the analysis. Equally, possession of an old certificate does not establish that the extension applies to every device it once covered.

Assemble the certificate history before drawing a conclusion. Include the original issue and expiry dates, amendments, device schedules, restrictions, withdrawals and relevant correspondence. If the certificate expired before the 2023 extension took effect, that history needs particular attention under the applicable Article 120 provisions.

Ask the regulatory reviewer to identify the exact certificate-validity basis rather than writing “extended automatically” beside every certificate. Where the interpretation depends on an agreement or competent-authority action, retain the actual record and its device scope.

Also distinguish certificate status from transition eligibility. A certificate may be part of the evidence chain without proving the QMS milestone, formal application, written agreement or ongoing conditions. Conversely, a past printed expiry date should trigger a structured review rather than an unsupported instruction to recall every unit.

What if you missed the May 2024 application deadline?

First establish whether the applicable formal application was genuinely missing or whether you have lost the evidence. If the relevant transition condition was not met, do not assume that a late application restores the extension. Starting MDR assessment now is a different decision from demonstrating historical transition eligibility.

Reconstruct the record from the application system, submitted package, submission receipt, correspondence and signed agreement. Check the legal manufacturer, device identifiers and scope, not just the subject line of an email. An early discussion about capacity or a quotation for future work is not interchangeable with the required application.

Where a condition appears unmet, involve your regulatory lead, the relevant regulatory adviser and other responsible functions promptly. Give them the device-level evidence, supply position and current certification status so they can decide what further placing on the market would require.

A competent-authority derogation or other exceptional regulatory route is not a routine late-filing service. If someone proposes one, require a device-specific legal basis and authority assessment. Do not build your commercial forecast around permission that has not been granted.

Separate warehouse stock from lawfully placed units

Stock questions need their own facts. Placing on the market concerns the first making available of an individual device on the Union market. It is not simply the date of manufacture, the presence of a CE mark or the day a pallet entered your warehouse.

For each affected batch, gather the transactions and supply records needed to establish whether and when the units were lawfully placed on the market. Then assess the applicable Article 120 stock provisions separately from permission to place additional units. Do not assume that every unit manufactured before an endpoint can continue through the supply chain on the same basis.

An illustrative inventory report might show 200 units held by the manufacturer and 80 units already transferred into distribution. Those numbers are invented and neither location proves legal status by itself. The useful question is which records establish the relevant supply event for each group, alongside conformity and safety status.

This distinction prevents two different errors. You should neither treat all inventory as already placed nor prescribe a blanket recall or disposal solely because a transition date or application issue has arisen.

What must continue during the extension?

Transition is not a pause in regulatory work. Eligible legacy devices remain subject to applicable obligations while the manufacturer prepares for MDR conformity assessment. The Commission-hosted surveillance guidance distinguishes that ongoing legacy-device oversight from the assessment needed for an MDR certificate.

Keep change control connected to the eligibility record. A proposed change in intended purpose or design needs an appropriate significant-change assessment before you assume the changed device can continue under the same transition basis. Neither the internal label “minor update” nor a commercial launch plan answers that question.

Post-market surveillance, vigilance and other applicable MDR requirements also need active ownership. Review safety signals for what they mean for the device, the evidence and the continued eligibility conditions. An open question about unacceptable risk cannot wait until the MDR submission project reaches its next milestone.

Surveillance responsibilities need equal clarity. Where the notified body performing MDR work differs from the body involved with the Directive certificate, identify who performs appropriate surveillance and document the arrangements. A contracting change should not leave the manufacturer assuming that someone else owns the next surveillance activity.

For example, a proposed software change may affect the intended users while leaving the commercial product name untouched. An illustrative transition register should flag the change for assessment, link the affected labelling and risk records, and distinguish the released configuration from the proposed one. A familiar product name does not establish continuity of regulatory scope.

Turn eligibility into an MDR preparation plan

Once you understand the eligibility position, separate three connected jobs. The technical-file gap assessment determines which evidence needs work. The clinical review determines whether the claims have sufficient support. The assessment plan determines how those dependencies fit with notified-body review and the applicable endpoint.

These jobs overlap, but they do not replace each other. A signed agreement cannot supply missing clinical evidence, and a rewritten clinical evaluation report cannot establish a historical application date.

Decide what to reuse, reassess and add

For the technical file, map the existing MDD evidence to the applicable MDR requirements. Start with the device description, intended purpose, classification and configuration so that the comparison concerns the product you actually intend to submit.

Use three decisions rather than a blanket instruction to rewrite everything. Reuse evidence where its applicability and sufficiency remain justified. Reassess evidence where changes in the device, claims, requirements or state of the art may affect its conclusions. Add evidence where the file does not substantiate the applicable requirement.

A verification report may remain useful while its applicability rationale needs revision. A renamed Essential Requirements checklist, however, does not establish that the MDR General Safety and Performance Requirements have been addressed. The crosswalk must identify the requirement, the supporting record and the remaining gap.

Keep this work linked to risk management, labelling and post-market evidence. If one intended-purpose statement changes, identify the dependent records rather than letting each document owner work from a different version of the device.

Separate clinical editing from clinical evidence gaps

An existing clinical evaluation report is a starting point, not proof that every MDR clinical requirement is met. The Commission-hosted MDCG 2020-6 guidance describes the use of existing evidence for legacy devices and the need to assess its sufficiency.

Check each intended-purpose, indication and population claim against the evidence that supports it. A literature search may need updating, an equivalence argument may need reassessment, or a claimed use may lack adequate evidence. Those are different problems with different work plans.

Post-market clinical follow-up can address appropriate remaining uncertainties, but a future plan is not a general substitute for the evidence needed for conformity assessment. Equally, legacy status does not mean every device automatically needs a new clinical investigation. The device, claims and applicable requirements determine the evidence strategy.

Plan from dependencies rather than the endpoint alone

The transition endpoint tells you when the conditional route ends. It does not tell you how long your assessment will take or guarantee a certificate before that date. Build a plan that separates manufacturer preparation, contracting, notified-body assessment, responses and the certification decision.

The Commission's notified-body survey distinguishes assessment categories and measures a defined period from written agreement to certificate issuance. A benchmark using that clock does not include all the work before the agreement and cannot predict your individual outcome.

For an illustrative project, suppose the technical-file owner cannot finalise the clinical evaluation until the intended-purpose wording is settled. The labelling and risk owners also depend on that decision. Scheduling three independent document deadlines would conceal the shared dependency. Resolve the claims decision first, then reforecast the connected work and confirm the submission sequence with the notified body.

Record what must happen before each milestone, who owns it and what evidence marks completion. Review the plan when a material gap, scope change or notified-body request changes those assumptions. Do not treat the endpoint as a substitute for time to respond to substantive questions.

Questions that come up during a transition review

A few distinctions help keep the eligibility decision separate from the certification project.

Does the extension mean our device is MDR certified?

No. Continuing under an eligible legacy-device route and obtaining MDR certification are different regulatory positions. Appropriate surveillance during transition does not itself establish completion of MDR conformity assessment.

Can one portfolio spreadsheet cover every device?

Yes, if it preserves device-level conclusions and the evidence behind them. A single status for a family is unreliable where variants have different application coverage, agreement schedules, classifications or change histories.

Does changing notified body automatically remove eligibility?

Do not infer the answer from the change alone. Review the relevant application and agreement history, device scope and surveillance arrangements with the bodies involved. Preserve the evidence needed to explain continuity and any unresolved conditions.

Can we fix an evidence gap by narrowing the intended purpose?

That may affect the clinical and technical strategy, but it is not a simple editorial repair. Assess the proposed change, its regulatory implications and all dependent records. Do not assume a revised claim preserves the same legacy-transition basis.

What should the first review produce?

It should give you a device-scoped eligibility conclusion, the evidence and assumptions behind it, unresolved questions with owners, and a separate MDR preparation plan. Where a condition appears unmet, the immediate output should identify the decision needed about lawful supply rather than promise a later certificate will repair the past.

Make the next decision from the records

The useful result is not a spreadsheet full of 2027 and 2028 dates. It is a defensible explanation of which devices can rely on which route, what remains uncertain and which evidence must be ready for the next stage.

Bring the device list, certificate history, dated application, executed agreement and current evidence gaps into the same discussion. That gives your regulatory reviewer a basis for separating an administrative retrieval problem from an eligibility problem or a substantive MDR evidence gap.

Talk to Dovetail about your transition questions.