MDD to MDR transition process step by step – 2025 update

Due to the introduction of the MDR regulation, all medical device manufacturers certified with a CE mark according to the Medical Device Directive (MDD directive) had to undergo the MDD to MDR transition process to continue to sell their products on the EU market. 

Even with the application deadline behind us, many medical device manufacturers are still finalising their MDR compliance. This article outlines the key steps to complete your MDD to MDR transition smoothly – helping you address remaining gaps, avoid delays, and stay compliant with EU MDR requirements through to final certification.

Why the MDD to MDR transition is still relevant

Although the MDR application deadline passed in May 2024, many device manufacturers are still in the process of finalising their MDR certification. That’s because extended transition periods remain in play. These run to 31 December 2027 for Class III and Class IIb implantable medical devices, and to 31 December 2028 for other eligible devices – provided that an MDR application was submitted on time, a valid MDD certificate was in place as of May 2021, and a compliant quality management system (QMS) has been implemented.

Several factors are contributing to the continued transition from the MDD to the MDR in 2025. These include Notified Body backlogs, technical documentation gaps identified during conformity assessments, internal team or IT system changes, and the need to onboard new devices following acquisitions. So, MDR compliance remains a pressing and active priority for medical device manufacturers. The steps below cover critical areas to reassess and improve – especially if you’re dealing with regulatory audits, documentation updates, or portfolio changes.

Be mindful of any changes to your medical devices

This remains critical even after submitting your MDR application. Any changes now could risk your eligibility for the extended MDR transition period and lead to delays in certification.

The CE certificate is valid as long as you don’t make any significant changes to the device. Any modification must be assessed in terms of safety and performance, and checked to ensure the intended use remains the same. If a change impacts the device’s risk classification or intended purpose, a new conformity assessment under the MDR regulation may be required.

Apply to the changed Post-Market Surveillance (PMS) requirements

As your organisation prepares for the final MDR certification, you must fully implement the updated post-market surveillance requirements, even if your existing certification remains under the MDD.

Monitor new guidance under EU MDR and adapt

With new Medical Device Coordination Group (MDCG) guidance regularly issued to clarify aspects of the EU Medical Device Regulation, you should stay up to date to ensure your QMS, technical documentation, and compliance procedures remain audit-ready. The expert guidance is available on the MDCG’s website. 

Revisit your MDR action plan to address any gaps

With the application deadline behind you, now is the time to revisit your MDR transition plan and address gaps highlighted during audits or Notified Body reviews. Stay flexible and responsive to reduce delays and ensure ongoing access to the EU market.

What is the MDD to MDR transition process?

If you’re still finalising your MDR certification in 2025 – or onboarding newly acquired product lines – these are the key steps to reassess or complete as part of your compliance journey.

We’ve prepared a step-by-step MDD to MDR transition checklist that you can follow. The steps don’t have to be completed in this exact order – depending on your business case, the sequence may vary.  

Step #1 Verify your product’s classification

Start by confirming whether your product qualifies as a medical device under the MDR. The EU MDR has a broader definition of a medical device than the MDD. For instance, software was not considered a medical device before.

The MDR introduced new, more rigid classification rules that particularly impact manufacturers of active implantable medical devices, surgical tools, and software. The most significant change affected medical devices that were classified as Class I under the MDD. Now, many of these fall under Class IIa or higher. The higher the risk class, the stricter the conformity assessment requirements.

Step #2 Update the technical documentation and labelling

Once you’ve verified your device’s MDR classification, review and update your labelling accordingly. The MDR requires medical devices to carry an MD symbol in a square frame. You must also revise barcodes to meet the Unique Device Identification (UDI) requirements (see step #3).

Importers of medical devices must ensure the label includes contact details and the identification of their authorised representative in the EU.

Step #3 Make sure your medical device meets the UDI requirements

Your device must be assigned three UDI identifiers:

• Basic UDI-DI – used in EUDAMED, on the Declaration of Conformity and in documentation describing the category of products.
• UDI-DI and UDI-PI – used to differentiate model variants or software versions, production batches, dates, etc.

Both UDI-DI and UDI-PI are encoded in the product barcode. Manufacturers must have a documented UDI assignment and grouping strategy. Once EUDAMED becomes fully operational, all UDIs will need to be uploaded to the database.

UDI traceability is essential in case of adverse events, field safety corrective actions, or product withdrawals.

Step #4 Choose and engage with a Notified Body

Only Class I medical devices (non-sterile, non-surgical and without a measuring function) can avoid Notified Body involvement. For all others – Class IIa, IIb, III and some Class I devices – you’ll need to choose a Notified Body and begin the conformity assessment process. Long waiting times and capacity limitations persist, so it’s crucial to engage early. You’ll need to define the intended purpose, device classification, and regulatory pathway before starting.

Step #5 Ensure you’re meeting all the obligations of a medical device manufacturer

This step can happen in parallel to other transition work – the earlier you begin, the more time you’ll have to adapt your processes.

Key MDR requirements for manufacturers include:

• Assigning a Person Responsible for Regulatory Compliance (PRRC).
• Registering your organisation in EUDAMED.
• Designating an authorised representative (if you’re based outside the EU or in a third country like the UK or Switzerland).

Step #6 Undergo conformity assessment and get certified

Your Notified Body will conduct both a readiness audit and a full MDR compliance audit. Although your device may have been on the market for years, the MDR treats certification as a new market entry.

Once your device has passed the audits, you’ll be able to sign the Declaration of Conformity, stating that it meets the requirements of the EU Medical Device Regulation. The date of signing also marks your official MDR market entry.

Step #7 Maintain continuous MDR compliance

Continuous MDR compliance is a long-term commitment. You must maintain up-to-date documentation, follow post-market surveillance requirements, and stay ready for follow-up audits or Notified Body interactions.

What is the timeline for the MDD to MDR transition?

The original CE certificates issued under the MDD are no longer sufficient for market access. All devices must now be certified under the EU MDR, but your conformity assessment process may extend until 2027 or 2028, depending on the device classification and submission timeline.

Still navigating the MDD to MDR transition?

Our consultants have extensive experience in the medical device industry and MDR regulation.

Whether you’re managing late-stage remediation, new product portfolio alignment, or addressing Notified Body findings, our team can support you every step of the way.

See our offer, get in touch, and book a no-obligation meeting with one of our MDR experts.

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