When to Adapt Devices to MDR, Explained Simply

The transitional provisions of Article 120, among other things, define by when to adapt CE-marked medical devices under Directive 93/42/EEC (MDD) to the MDR. To do this, they use the concepts of placing on the market and making available.

In particular:

• Class I devices CE marked under MDD
  • If they change class or are reusable surgical instruments: they can be placed on the market until May 26, 2024 (with a declaration of conformity drawn up before May 26, 2021) provided there are no significant changes in design and intended purpose.
  • Otherwise, they can no longer be placed on the market. However, they can be made available until May 26, 2025 if they were placed on the market before May 26, 2021.

• Class IIa, IIb, III devices CE marked under MDD
  • If the related certificate is valid: they can be placed on the market until the certificate expires (no later than May 26, 2024) provided there are no significant changes in design and intended purpose.
  • Otherwise, they can no longer be placed on the market. However, they can be made available until May 26, 2025 if they were placed on the market before May 26, 2021.

To truly understand by when to adapt devices to MDR, it’s crucial to clarify the meaning of placing on the market and making available.

Placing on the Market and Making Available

Placing on the market is the FIRST making available.

Making available is the supply for distribution, consumption, or use, even free of charge, without physical delivery, of each individual product (not the type or model it belongs to) regardless of whether it was manufactured as a single unit or in series.

Supply is any “offer” for distribution, consumption, or use on the European Union market that may result in an actual supply (for example, an invitation to purchase or advertising campaigns).

Therefore:

Placing on the market is the first “offer” for distribution, consumption, or use, even free of charge, of a single specific product already manufactured, even without physical delivery.
Subsequent “offers” of that single product are called making available.

From the above, it follows that only the manufacturer or the importer can place a product on the European Union market. Distributors always and only make available.

However, note that an offer concluded before the manufacturing phase has been completed cannot be considered placing on the market.

When to Adapt Devices to MDR, Explained Simply

Given the above, the most critical element that allows considering the device as placed on the market is, ultimately, the physical availability of the product in stock.

Similarly, a product that can no longer be placed on the market practically can no longer be manufactured unless it is adapted to the MDR.

These considerations can therefore replace the concept of placing on the market.

Therefore, simply put:

After May 26, 2021, Class I devices that do not change class and are not reusable surgical instruments, and Class IIa, IIb, III devices that do not have a valid MDD certificate, must be adapted to the MDR, otherwise they can no longer be manufactured. Any stock inventory can be sold until May 26, 2025.