MDCG guidance,
in plain English

Only the manufacturer may assign UDIs — the MDCG's answer to distributors obtaining their own UDI-DI codes for rebranded devices.

Who uploads the SSCP to EUDAMED after the May 2026 mandatory date — the task moves from notified bodies to manufacturers, with a deadline for devices placed on the market before mandatory use.

The version history of the EMDN for 2026 — the authoritative record of the nomenclature as it stands after the annual revision.

The consolidated change log of the 2025–2026 EMDN annual revision: every code insertion, modified term, deletion and split, in one spreadsheet.

The outcome of the 2025 EMDN annual revision cycle: which nomenclature change requests were accepted, partially accepted, or rejected — and why.

The EU framework for designating medical devices and IVDs as breakthrough technologies, obtaining expert advice and planning proportionate evidence.

The MDCG's first dedicated guidance on the post-market surveillance system: what your PMS plan must contain, which data sources count, and how PMS feeds risk management and clinical evaluation.

How the EU AI Act applies alongside MDR or IVDR to medical device AI, from high-risk status and data governance to conformity assessment and PMS.

The MDCG's 54-question guide to IVD performance studies, including when an application, notification or neither is required under the IVDR.

How MDR/IVDR and Digital Services Act responsibilities apply when medical device software apps are offered through app stores and online platforms.

How to assign Basic UDI-DIs and Master UDI-DIs to spectacle frames, spectacle lenses and ready-to-wear reading spectacles, with assignment triggers.

The implementation timeline for Master UDI-DI on contact lenses, spectacle frames, spectacle lenses and ready-to-wear reading spectacles.

The official spreadsheet of EMDN terms inserted, modified, deleted or split in the 2024-2025 annual revision, with practical guidance for updating data.

A plain-English record of which 2024 EMDN change proposals were accepted, partly accepted or rejected, and the reasoning behind those decisions.

The official form for requesting an ad hoc EMDN code when no suitable code exists and the code is needed for UDI-DI registration in Eudamed.

What goes into a PSUR, how often to update it, and how notified bodies assess it.

The official template for reporting the results of your post-market clinical follow-up.

The official template for post-market clinical follow-up plans — section by section.

The evidence bar your MDD-era device must clear for MDR certification, and which data sources count.

Which design or intended-purpose changes make your MDD device lose its transition-period grace — and which don't.

Is your software a medical device at all — and if so, which class? The decision steps, explained.