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Operational notes Regulation

Medical devices: when the technical file and the paper leaflet actually expire

6 min read

The cut edge of a ream of blank paper shot in extreme close-up, with the sheets curving in overlapping layers, in black and white
Behind a single product code: a technical file, a clinical evaluation, a leaflet to be rewritten in electronic form.

A manufacturer of medical devices who has put off rewriting the technical file for a class IIb product, believing there are still years of leeway, is counting the wrong years. And a manufacturer who has just reprinted the paper leaflet for a device intended solely for a hospital ward may have done so for an obligation that has not existed for more than a year.

Two dates that matter, and the condition that precedes them

Regulation (EU) 2017/745 (MDR) on medical devices does not close the old regime overnight: for legacy devices — those still covered by a certificate issued under Directives 90/385/EEC and 93/42/EEC — it sets a two-tier market-exit deadline. The consolidated text, incorporating the amendments made by Regulation (EU) 2023/607 of 15 March 2023, states in Article 120(3a): «31 dicembre 2027, per tutti i dispositivi della classe III e per i dispositivi impiantabili della classe IIb» (31 December 2027, for all class III devices and for implantable class IIb devices) — with named exceptions, sutures, dental fillings, orthopaedic screws and plates, left out. All other legacy devices, from non-implantable class IIb to sterile or measuring-function class I, have until 31 December 2028.

The point most miss lies elsewhere, and it has already passed. The extension is not automatic: paragraph 3d makes it conditional on three deadlines of its own — a quality management system in place by 26 May 2024, a formal application to a notified body by the same date, a signed written agreement by 26 September 2024. A manufacturer who missed those steps does not reach 2027 or 2028: the device is already off the market today, whatever date the calendar still shows.

The paper leaflet is no longer guaranteed

In parallel, the form of the instructions for use is changing. Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 allowed paper to be replaced with electronic instructions only for three families of device: implantable devices, those fixed and installed within a healthcare facility, and those fitted with their own screen to display them. Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025, in force since 16 July 2025, has removed that list: the scope now extends to «tutti i dispositivi medici e relativi accessori contemplati dal regolamento (UE) 2017/745 destinati agli utilizzatori professionali, compresi i dispositivi che rientrano nell’ambito di applicazione delle disposizioni transitorie di cui all’articolo 120 del regolamento (UE) 2017/745» (all medical devices and accessories covered by Regulation (EU) 2017/745 intended for professional users, including devices falling within the scope of the transitional provisions under Article 120 of Regulation (EU) 2017/745) — including the legacy products above — and non-medical-purpose products under Annex XVI, where intended for professional use.

One constraint still has to be checked device by device, not catalogue by catalogue: «Qualora sia ragionevolmente prevedibile che un dispositivo destinato a utilizzatori professionali sia utilizzato anche da utilizzatori profani, i fabbricanti forniscono le istruzioni per l’uso destinate a utilizzatori profani su supporto cartaceo» (where it is reasonably foreseeable that a device intended for professional users will also be used by lay users, manufacturers shall provide the instructions for use intended for lay users on paper). A device a hospital buys but which may end up in a patient’s hands does not qualify for the exception: for that one, the paper leaflet stays mandatory.

Same product code, two files to rewrite

In Mirandola, in the province of Modena — not far from our own base in Vignola — one of Europe’s most significant biomedical clusters has grown up: hundreds of companies in medical devices, from implants to diagnostics, many already within the scope of NIS2 for critical manufacturing. For each, every legacy product code carries two files expiring on different calendars but converging on the same documents: the technical file and clinical evaluation to be rewritten under the MDR by 2027 or 2028, and the instructions for use to be reclassified — electronic for the professional user, paper wherever a lay user appears in the chain. A company with a few hundred codes on its catalogue is not managing one deadline: it is managing hundreds, each with its own notified body, file and mix of users.

What to do now

Marking 2027 and 2028 on the calendar is not enough. The first check, for every legacy device still on sale, is whether the three 2024 conditions were actually met: without that check, a product believed to be covered by the extension may no longer be. Then the same question has to be asked for eIFU, code by code: who uses it — a professional only, or a lay user too? The answer decides whether the instructions can move to the manufacturer’s website — with the address printed on the label and, once registration becomes mandatory, in the Eudamed unique device identifier database — or whether paper remains an obligation. Keeping a written record of every check, not just the outcome, is the first thing a notified body asks for in a surveillance audit.

How we solve it

Rewriting technical files and clinical evaluations across hundreds of product codes is not a stylistic exercise: it is the extraction and reassembly of highly confidential documentation, often the information asset that sets a device apart from its competitor. It is not work to hand to anyone who cannot guarantee where that data ends up. Our approach runs a control across the technical file and clinical evaluation of every code — with the audit trail ready to show a notified body — and uses the same foundation to hold product catalogue, deadlines and compliance files together in a single operating model, on which AI agents execute with an operator in command. Always within the client’s own perimeter: on premises on dedicated machines in the manufacturing sector, or in a dedicated cloud with a data centre in Italy — without the company needing in-house staff to administer these systems.

If you have a catalogue of legacy devices to bring into line, let’s talk.

Sources

What we don’t know

We have not checked whether, beyond Regulation (EU) 2023/607, a further amendment to the 2027 and 2028 deadlines is now under discussion: the 2023 precedent shows the Commission can intervene again before the deadline, and we would not rule it out. We have no primary-source figure for the exact number of companies in the Mirandola cluster, nor for the share of legacy devices still in circulation on the Italian market: the cluster’s importance is well established, the detailed numbers are not, and we have not quoted any. Finally, for no specific company do we know whether the three 2024 conditions — quality system, application, signed agreement — have already been met: that is a check made case by case, on each device’s file, not from a distance.