It is becoming increasingly clear that the last traces of the MDD (Directive 93/42 EEC on medical devices) are fading away.
The market is increasingly demanding that product certifications be adapted to the requirements of EU MDR 2017/745.
Legacy devices are going out of fashion
Medical devices whose certification dates back to the MDD era are referred to as legacy devices. Legacy devices are therefore tested according to the standards of an expired directive. Due to the transitional provisions of Art. 120 MDR, such legacy devices may still be marketed until 2027 or 2028 under the right conditions – but it is becoming apparent that the market is ahead of the legislation.
As our discussions at MEDICA 2025 in Düsseldorf and our day-to-day business show, MDD certification is enjoying less and less trust. One reason for this is that most buyers and importers have already become accustomed to the more uniform MDR certification – another is that MDD certifications will expire in 2027/28 in accordance with Art. 120 MDR.
Customers, especially clinics and medical centres, who require large quantities and long-term planning, are therefore increasingly sceptical about MDD-certified legacy devices.
This is accompanied by an overall decline in demand and an increase in unsold supply for medical devices that do not yet have MDR certification, and manufacturers are often left with their MDD-certified legacy products.
Capacities at the notified bodies
Since 2021, MDD certifications have been gradually expiring in accordance with Article 120 of the EU MDR. This has led to a veritable rush on the Notified Bodies in recent years – manufacturers naturally wanted to keep their product ranges on the market and renew their certification to do so.
However, this initially overwhelmed the notified bodies – a predictable problem, according to the BVMed. Waiting times for MDR certificates skyrocketed, exceeding one year in over 75% of cases!
However, this excessive demand now seems to be easing. In 2025, BEO BERLIN was able to organise audit appointments for its partners within three months without any problems.
Good documentation is key
Of course, the path to MDR certification is still no walk in the park. To ensure that notified bodies can process manufacturer applications quickly and avoid frustrating back-and-forth exchanges, it is important to be well prepared.
In particular, manufacturers can save a lot of time and hassle by maintaining flawless product documentation – then the MDR certificate will follow quickly.
So let's summarise: as the expiry dates for legacy products approach, confidence in the reliable availability of MDD-certified products is dwindling. This is leading to reduced demand for these products and putting manufacturers under pressure: Certification in accordance with EU MDR 2017/745 is no longer just a nice extra: not having it is a disadvantage! Fortunately, the notified bodies once again have more capacity than in recent years – with solid product documentation in hand, manufacturers can expect fast, uncomplicated MDR certification!
Obtaining the MDR certificate with BEO BERLIN
The biggest hurdle for manufacturers is therefore no longer necessarily the waiting time at the notified bodies, but rather the professional preparation of the necessary documentation. Adapting to new standards and integrating the requirements of the MDR into processes can be extremely time-consuming – especially if manufacturers do not have their own regulatory compliance department.
This is precisely where BEO BERLIN comes in: we make our expertise in regulatory compliance available to manufacturers and work with them to quickly and pragmatically create documentation, quality management systems and market surveillance mechanisms. We organise audit appointments for you and get your products onto the market and into the medical aids directory in no time at all!
Contact us – we look forward to hearing from you!
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