MDD to MDR migration

Move your legacy MDD technical file to EU MDR before the transition deadline, with AI drafting and specialist review.

If your device is still on a Medical Device Directive (MDD) certificate, its technical file has to be rebuilt to EU MDR requirements before the transition period ends. Obodux helps you import your MDD file, see exactly what needs adding or restructuring, and work through it with AI drafting and specialist review.

The deadlines are fixed in law: the end of 2027 for higher-risk legacy devices and the end of 2028 for others, provided the conditions of Regulation (EU) 2023/607 are met. Our guide to MDR and IVDR transition deadlines explains the conditions.

What changes from MDD to MDR

Area	Under MDD	Under EU MDR
Requirements	Essential Requirements (Annex I, 93/42/EEC)	General Safety and Performance Requirements (Annex I, 2017/745)
File structure	Varies by manufacturer	Prescribed by Annex II and Annex III
Clinical evidence	Often literature-based	Stricter clinical evaluation, equivalence and PMCF rules
Post-market surveillance	Vigilance-focused	PMS plan, PSUR or PMS report, and PMCF
Identification	No UDI	UDI and EUDAMED registration

How Obodux helps you migrate

Import your MDD file
Upload the existing technical file and supporting documents. Obodux maps them into its MDR-aligned structure.
Get a free gap analysis
See which content carries over, what Obodux consolidates, and what is missing or referenced but not supplied. Learn about the free gap analysis.
Rebuild the GSPR checklist
Move from Essential Requirements to a GSPR checklist with applicability, standards and evidence for each requirement.
Fill the gaps
Use guided templates and AI drafting for new MDR content such as the PMS plan, PMCF rationale and updated clinical evaluation.
Get specialist review
Ask Obodux regulatory specialists to review the sections that matter most before your notified body submission.

Who it is for

Manufacturers with legacy devices certified under the MDD
Teams that need to show progress to a notified body under the extended transition rules
Companies also maintaining a UKCA technical file for Great Britain

Common questions

Can we reuse our MDD documentation?

Much of it, yes. Device description, labelling, design, risk management and test reports usually carry over. The analysis shows what can be reused, what needs restructuring and what is new under MDR.

Do we still need our Essential Requirements checklist?

It can be kept as supplementary evidence during the transition, but the GSPR checklist becomes the operative matrix under MDR.

Will Obodux guarantee our MDR certificate?

No. Obodux is a documentation tool with optional specialist review. Your organisation remains responsible for its technical documentation and submissions.

Start your MDD to MDR migration

Begin with a free gap analysis of your current file, or try Obodux free for 4 weeks.

Get a free gap analysis Start 4-week free trial

Obodux is a documentation tool from BORIS Software Ltd. It does not provide legal or regulatory advice and does not guarantee CE, UKCA or any other approval. AI suggestions are guidance only, and manufacturers remain responsible for their technical documentation. Further reading: EU MDR technical file software.

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Obodux is a SaaS platform that streamlines medical device compliance. Using AI tools and a secure workspace, it helps prepare CE, UKCA, and global documentation faster, stay audit-ready, and launch products confidently.

Compliance Disclaimer: Obodux provides tools to assist with regulatory compliance but does not guarantee regulatory approval. Users remain responsible for ensuring their compliance with applicable regulations.