MDR transition periods 2027 and 2028: which date affects manufacturing

In medical technology, two dates appear in almost every planning document: December 31, 2027, and December 31, 2028. Both originate from the MDR transition periods, and both are often interpreted as meaning that something will change in manufacturing afterward. This is not the case. They regulate how long certain older products may remain on the market.

The date on which the line actually changes is before both dates and is mentioned far less frequently. This article puts the three dates in order, while remaining true to the current legal situation.

What the MDR transition periods actually extend

The two deadlines are set out in Article 120(3a) of Regulation (EU) 2017/745 on medical devices. They apply to products for which a certificate was issued before the Regulation came into force, either under the Active Implantable Medical Devices Directive (90/385/EEC) or under the Medical Devices Directive (93/42/EEC). This refers to existing products, not new developments.

The deadline of December 31, 2027 applies to Class III products and Class IIb implantable products. Exemptions include sutures, staples, and dental fillings.

December 31, 2028 applies to the remaining products of Class IIb, to products of Class IIa and to products of Class I that were placed on the market sterile or with a measuring function.

Paragraph 3b adds to this list products that did not require a notified body under the old directive but for which a notified body is now required under the regulation. Paragraph 3c makes the extension subject to conditions; it is a longer list, and it determines on a case-by-case basis whether the extended deadline applies at all.

Why the data is missing from the 2017 regulation text

Anyone looking for these two dates in the original text of the 2017 regulation will not find them. Paragraph 3a was only added later, by Regulation (EU) 2023/607. Consolidated versions contain it, but older printouts and many in-house PDF files do not.

This explains some of the confusion surrounding these deadlines. They are often presented as years, while the conditions to which they are attached are contained in the same regulation and are less frequently cited.

Market access is not manufacturing

The difference isn't a legal distinction; it changes the planning process. A deadline that regulates how long an older product may remain on the market and available says nothing about how that product is manufactured, labeled, or tested.

For manufacturers, this means that the pressure the industry derives from this data is real. It arises from certification projects, the workload of notified bodies, and decisions about which existing products will even be brought under the regulation. However, the MDR transition periods do not create any new tasks on the production line.

This is precisely why deadlines often appear in the wrong place in project plans. They end up in production planning, even though they belong in approval planning.

What this means for contract manufacturers and suppliers

The obligations of the regulation fall on the manufacturer. Those who perform turning, milling, marking, or packaging on behalf of a client receive them via specifications and supply contracts, often without being provided with the relevant legal information.

For the supply chain, this distinction is therefore of practical value. An inquiry based on the 2027 and 2028 deadlines usually concerns the documentation of an existing product and the question of whether it will continue to be produced. An inquiry citing May 26, 2027, concerns the marking itself.

These are two separate conversations, with different contacts and different lead times. Keeping them separate saves you from unnecessary coordination loops.

May 26, 2027: the labeling moves to the product

The deadline directly related to production is different. According to Article 123, paragraph 3, letter g, point iii of the Regulation, from 26 May 2027, reusable Class I products must have the UDI carrier affixed to the product itself. Until then, the carrier on the label and packaging is sufficient.

This refers to products that are reprocessed and reused after use. In Class I, these are primarily reusable surgical instruments: forceps, scissors, clamps, sieve and tray parts, as well as accessories that undergo the same reprocessing procedure.

Two things are regularly confused here. UDI marking on the label has been around for some time and pertains to printing and packaging. Direct marking on the product is a marking embedded in the material or on the surface of the component, usually by laser. Both are called UDI, both use the same number, but they represent different manufacturing steps at different points in the production line.

What Annex VI requires regarding durability

Direct marking includes a second requirement, which is set out in Annex VI, Part C, point 4.10: The marking must be permanently affixed and remain legible after each reprocessing procedure by which the product is prepared for reuse.

This is the production-related part of the appointment. An instrument undergoes many cycles of cleaning, disinfection, and steam sterilization over its lifespan. Therefore, a code that looks perfect immediately after marking is not necessarily the code in question.

The requirement raises a question of proof: Does the marking remain legible across the intended reprocessing cycles, using the reading devices actually employed in the clinic and reprocessing department? The regulation does not specify how this proof is to be provided. It requires the result, not the method.

The fact that a visual inspection of the marking at this point can be helpful is a conclusion drawn from manufacturing practice and is not explicitly stated in the regulation. Which inspection method is appropriate for a specific instrument, a specific marking, and a specific reprocessing procedure can only be determined on a case-by-case basis.

What follows from this?

If you sort the three dates according to their distance from today, a different picture emerges than in the public discussion. The next deadline is May 26, 2027, about eight months away, and it concerns the marking on the component. The two frequently cited deadlines are 15 and 27 months away and concern market access for older products.

For the regulatory authorities, the MDR transition periods remain the dominant issue. For the manufacturing authorities, it is the earlier deadline, along with the question of whether the marking can withstand reprocessing.

Anyone managing both aspects within the same project plan should keep the two tracks separate. They have different stakeholders, different lead times, and require different documentation. And they answer different questions: one, whether a product can continue to be marketed; the other, how it can still be identified after years of use.

Want to know what this means for your exam? Contact us.