MDD to MDR: what legacy device status does and does not buy you

The MDD, Medical Device Directive 93/42/EEC, was the framework CE marked devices ran on for a generation. It was replaced by the EU Medical Device Regulation (MDR), which applied from 26 May 2021. The MDD to MDR transition is still not finished, because many devices remain on the EU market under old directive certificates as legacy devices on extended deadlines. Those extensions are real and generous. They are also conditional, and some manufacturers are relying on a status they no longer hold.

Directive versus regulation

A directive is transposed into national law by each Member State, which is why the MDD produced a slightly different version of the same requirement in every country. A regulation applies directly and identically everywhere. The MDR also raised the bar on clinical evidence, on post market surveillance and on traceability, so a device that passed comfortably under the MDD can have real gaps against it. That is what our MDR and IVDR transition service closes.

What a legacy device actually is

The term is narrower than it gets used. A legacy device is either a device that was Class I under the MDD, with an EC declaration of conformity drawn up before 26 May 2021, that now needs a Notified Body under the MDR; or one covered by a valid EC certificate issued under the MDD or the Active Implantable Medical Devices Directive before 26 May 2021.

Not everything with an old certificate qualifies. A device placed on the market before 26 May 2021 is an old device, under different rules again.

The deadlines, and the conditions attached to them

Regulation (EU) 2023/607, in force from 20 March 2023, extended the transition. Under the amended Article 120(3a), devices with a valid directive certificate may be placed on the market until 31 December 2027 for all Class III devices and Class IIb implantable devices other than sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors; and until 31 December 2028 for other Class IIb devices, Class IIa devices, and Class I devices placed on the market sterile or with a measuring function. Article 120(3b) gives the same 2028 date to MDD self declared Class I devices that now need a Notified Body.

Which date applies is decided by the MDR Annex VIII rules, not the class printed on the old certificate. A device can have been Class IIa under the directive and Class IIb under the regulation, and the date follows the new class. One more reason to settle classification early.

The conditions in Article 120(3c) are all five, not a menu. Continued compliance with the directive the device was certified under. No significant changes in design or intended purpose. No unacceptable risk to patients, users or public health. A quality management system meeting Article 10(9) of the MDR in place no later than 26 May 2024. And a formal application lodged with an MDR Notified Body no later than 26 May 2024, with a written agreement signed no later than 26 September 2024.

The last two bite hardest, and both dates have passed. If the application was not lodged and the agreement not signed in time, the extension does not apply, whatever the certificate says.

What legacy status does not buy you

It does not exempt you from the MDR. Article 120(3d) applies the regulation’s requirements on post market surveillance, market surveillance, vigilance and registration of economic operators and devices to legacy devices in place of the directive equivalents, and the MDCG guidance on those subjects applies with it. You are on directive rules for the product and regulation rules for everything after it ships. Legacy status buys time on conformity assessment and nothing on the post market side, which is where Notified Bodies now look hardest.

It does not allow significant change. Redesign the device or extend its intended purpose and you are outside the exemption.

It does not cover Unique Device Identification. Legacy devices are not subject to the MDR identification requirements, and are registered in EUDAMED under a EUDAMED identifier, or a UDI-DI if one exists. Registration still applies. The full scheme does not.

The sell off date is gone

One genuinely helpful change. The deadline for continuing to make available devices already placed on the market was deleted, so units lawfully placed on the market before 26 May 2021 or during the transition can still be supplied, limited only by shelf life. Placing on the market means each individual unit, not a product type, and that decides whether warehouse stock is covered.

The point at which the certificate stops helping

The end of the transition is not the date you start work. Conformity assessment for a Class III device takes many months and Notified Body capacity is finite. Work backwards from 31 December 2027: the documentation has to reach the reviewer well before then, and the clinical evidence has to exist before the documentation does. Our piece on what a Notified Body actually checks sets out what that file has to survive.

Where Worldwide Device Solutions fits

We move legacy portfolios onto the regulation for a living, starting with a gap analysis against your actual certificates and classes rather than a generic timeline. More than 500 CE technical files built and approved. Paul Rowden offers a free twenty minute call to confirm whether your legacy status still holds, at no cost and no obligation.