Annex XVI's transition started from zero, not a lapse

Six groups that were never devices at all

Annex XVI lists six groups of products without an intended medical purpose that MDR brought inside its own reach anyway: contact lenses and similar items introduced into or onto the eye; products introduced into the body through surgically invasive means to modify anatomy, other than tattooing and piercing products; substances and items for facial or other dermal filling by injection; equipment for reducing or removing adipose tissue, such as liposuction or lipolysis equipment; high-intensity electromagnetic radiation equipment used on the body, including lasers and intense pulsed light devices, for skin resurfacing, tattoo removal, or hair removal; and equipment for brain stimulation using electrical currents or magnetic fields that penetrate the skull. None of the six carried device status under the old Medical Device Directive, because nothing in that directive reached a product with no medical purpose at all — a colored contact lens seller or a laser hair-removal clinic had no premarket dossier, no quality management system obligation, and no notified body relationship to speak of before MDR's own Annex XVI changed that.

Common specifications, not a grace period

Commission Implementing Regulation (EU) 2022/2346, laying down common specifications for the six Annex XVI groups, applied from 22 June 2023. The specifications run across seven annexes — a general-requirements annex plus one product-specific annex per group — each setting its own risk management and labeling requirements, and for the higher-risk groups, specific requirements for clinical data. From that date, a manufacturer in one of the six groups owed a technical file, a conformity assessment, and, for most groups, notified body involvement, as though the product had always been regulated as a device. Nothing about the regulation's own application date treated that as a distant horizon a manufacturer could plan toward at leisure.

The same 2024 gate, approached from zero

Commission Implementing Regulation (EU) 2023/1194 aligned Annex XVI's own transitional provisions to the extended dates Regulation (EU) 2023/607 had already set for legacy MDD devices generally: 31 December 2027 for the higher-risk groups, 31 December 2028 for the rest. Both dates carry the same procedural condition this blog has already covered for legacy devices — a quality management system in place and a signed written agreement with a notified body by 26 May 2024 — but the manufacturer qualifying for an Annex XVI extension wasn't renewing a certificate it already held. In most cases it was standing up a QMS, approaching a notified body for the first time, and assembling a technical file from nothing, inside roughly the same eleven months, 22 June 2023 to 26 May 2024, that a device manufacturer with decades of existing paperwork used to extend a certificate it already had.

A missed gate leaves no product, not a shorter one

A device manufacturer that missed one of Article 120's 2024 conditions still held an old MDD certificate, even one about to lapse without the extension. An Annex XVI manufacturer that didn't lodge a notified-body application or sign an agreement by 26 May 2024 has no certificate to fall back on and no shorter transitional window to land in instead. The product simply has no basis for being on the EU market under the regulation's own transitional scheme at all — it isn't running down a shorter clock the way a late-filing device manufacturer might still argue for; there's no clock running for it in the first place.

Where this meets the file

An Annex XVI compliance tracker needs the same fields a legacy-device transition file already keeps — the notified body application date, the signed agreement date, the applicable 2027 or 2028 deadline by risk tier — plus one field a device tracker never had to carry: confirmation that the product held no prior device certification to extend, since the 2024 gate is doing different work depending on which column a given product falls into. A tracker built to carry that distinction, alongside the launch catalog's other EU MDR templates, is previewed there now. If your program has tracked Annex XVI's transition differently, the shelf takes that correction directly.