The EU Commission only published the draft amendment to the Medical Device Regulation (MDR) on January 6th, and on February 16th the European Parliament approved the amendment with more than 95% of the votes cast. On March 7th, the European Council also nodded. On March 15^th , the proposal was formally adopted by the EU Parliament and the Council. Immediately afterwards, on March 20th, it was published in the Official Journal of the EU and the new regulations came into force immediately.

Why this sudden rush? The many warning voices from industry, doctors and the notified bodies, which have pointed out the serious consequences of the MDR for both individual patients and the medical device industry in Europe, have also arrived in the EU (late, but hopefully not too late). The EU itself admits that it had to act now to avert "the imminent threat of a shortage of medical devices and the consequent threat of a public health crisis". To put it bluntly: a crisis that they brought themselves about in 2017 with the adoption of the MDR.

What exactly is changing now? On the one hand, and this is to be welcomed for many reasons, the sell-off rule is no longer applicable. After all, it was economic and ecological nonsense that it was forbidden to resell proven, error-free and effective medical devices from May 27th, 2025 if they "only" met the requirements of the MDD, i.e. the Medical Devices Directive, and not of the MDR.

On the other hand, the transition periods of the Medical Device Regulation, in which a changeover from the MDD to the MDR must take place, will be postponed significantly in the future, depending on the risk of the respective products:

• for implantable custom-made products of risk class III on May 26th, 2026

• for class III devices and class IIb implantable devices (with the exception of e.g. dental fillings, dental braces, dental crowns, connectors) to December 31st, 2027

• for all other IIb products, for IIa products and I* products on December 31st, 2028.

But you still have to be careful - the extension of the transition periods only applies to products for which all of the following conditions are met cumulatively:

• The products must continue to meet the requirements of the MDD

• There must be no significant changes to the design and purpose (this can be interpreted very narrowly by the notified bodies, so that adaptations and further developments of existing products are often only possible to a very limited extent)

• The products do not pose an unacceptable risk to the health and safety of patients, users or third parties

• By May 26th, 2024, the manufacturer must have introduced and implemented a complete quality management system in accordance with the requirements of the MDR (and thus fulfill practically all essential points of the MDR)

• The manufacturer must have submitted an application for certification to a notified body by May 26th, 2026 and concluded a certification contract by September 26th, 2026 (this can be a challenge given the ongoing capacity bottlenecks of the notified bodies).

So no company can sit back and say "we've gained two, three or even four years, so let's slow down and take it easy...".

What we have noticed from time to time: some companies do not know that some requirements of the Medical Devices Regulation have been in force and implemented since May 2021, regardless of the transitional provisions: those for post-market surveillance, for market surveillance, for vigilance (i.e. for the reporting system towards the authorities), for the registration of economic operators and products. Anyone who still has some catching up to do should act as soon as possible.

Despite all the joy about the postponement of the start of validity, this gives you space to catch your breath for a short time, nothing more. The structural problems of the MDR remain.

Above all, this includes the huge effort involved in having completely (re-) certified again (this time according to the rules of the MDR) already proven products, some of which have been on the market for decades without any problems.

That costs money – a lot of money – and ties up staff who are unable to develop new products. For this reason, manufacturers are streamlining their product portfolios, and products are irretrievably disappearing from the market. Initial registrations no longer take place in Europe, but in other countries where less prohibitive conditions prevail. The production migrates with them.

As a result, Europe as a location for medical products is catapulting itself into oblivion.

Update: To follow up on the events to date, we recommend our first article on the topic of MDR www.caddent.de/en/blog/medical-device-regulation