MDR / IVDR
EU MDR and IVDR transition and compliance
Devices legally on the market under the old EU Medical Devices Directive or IVD Directive have to transition onto EU MDR 2017/745 and IVDR 2017/746 within deadlines that vary by device class. For MDR legacy devices the extended dates are 31 December 2027 and 31 December 2028, and they only apply to devices that met the conditions set in 2024. Leaving this until close to a deadline is how manufacturers lose market access on devices that have been selling safely for years.
Why this is bigger than it looks
MDR and IVDR are not the old directives renamed. They raise the bar substantially on clinical and performance evidence, require live post market surveillance rather than a document filed once, and change how Notified Bodies review a file. A device that passed comfortably under the old directive can still have real gaps against the new regulation.
We led the Abbott IVDR transition programme, a $250 million project across eight countries, which is the scale of coordination this kind of transition can demand when a portfolio, not a single device, is involved.
Gap analysis before remediation
The right first step is always establishing exactly where a device or portfolio stands against the new requirements, not starting to rewrite documents blind. A gap analysis done first identifies which evidence exists, which is thin, and which does not exist at all, so remediation work is targeted rather than a wholesale rebuild of a file that was mostly fine.
Deadline planning that accounts for reality
Under Regulation (EU) 2023/607 the MDR dates depend on device class and on having met the conditions: an MDR quality management system and a Notified Body application by 26 May 2024, and a signed written agreement by 26 September 2024. The IVDR dates, as amended in 2024, run by class to 31 December 2029. We plan against your actual certificates, classes and paperwork, not a generic timeline, and build in the lead time that clinical evidence and Notified Body review take.
Questions we get asked
My device is already CE marked. Why does it need more work?
MDR and IVDR raised the evidence bar substantially compared with the old directives. A device that passed under the old rules can still have real gaps against the new ones, particularly on clinical evaluation and post market surveillance.
What happens if I miss my transition deadline?
It depends on whether your device met the transition conditions. If it did, a certificate that has since expired can still count until the extended date for its class. If it did not, you cannot rely on the extension and the device needs a certificate under the new regulation to go on being placed on the market. Units already placed can continue to be made available, because the sell off date was removed.
Can you handle a whole portfolio, not just one device?
Yes. The Abbott IVDR programme covered a multi country portfolio, not a single product, so portfolio level sequencing and prioritisation is work we have done at real scale.
Guides on MDR and IVDR Transition
SSCP upload in EUDAMED moves to you: the October 2026 change and the February 2027 date
From October 2026 manufacturers, not Notified Bodies, upload the SSCP to EUDAMED. What MDCG 2026-4 changes, who it catches and why 27 February 2027 is the date to plan for.
Clinical evaluation for medical devices under the EU MDR
Clinical evaluation for medical devices under MDR Article 61 and Annex XIV: the CER, PMCF, equivalence under MDCG 2020-5 and when to run an investigation.
EU MDR explained: Regulation (EU) 2017/745, deadlines and duties
The EU MDR in plain English: what it covers, who it binds, the 2027 and 2028 transition deadlines and why the simplification is still only a proposal.
IVDR explained: in vitro diagnostic regulation, classes and deadlines
The IVDR in plain English: how IVDs are classed A to D, when a Notified Body is needed, every transition deadline, the Class C date and in house tests.
ISO 14155: when a clinical investigation is actually required
ISO 14155:2026 sets good clinical practice for device investigations. When one is actually required, when existing data is enough, and what a sponsor takes on.
MDCG guidance documents: not law, and not optional either
MDCG guidance is not law, but Notified Bodies work to it. Which documents every manufacturer meets and how to use them without treating them as a checklist.
MDD to MDR: what legacy device status does and does not buy you
The MDD is gone but its certificates are not. How legacy device status works, what the extended deadlines required, and when an MDD certificate stops helping.
IVDR gap assessment: where you stand
Most IVD manufacturers think they are further along than they are. A Gap Assessment tells you the truth before a Notified Body does.
Not sure where you stand on this?
Book a free consultation, or start with a fixed fee Gap Assessment. No pitch. If it's already handled, we'll tell you that.
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