BERLIN, Germany,

Preparation Pays Off, but Hurdles Remain

BIOTRONIK First to Achieve Highest-risk MDR Certification

Medtech companies operating in Europe are getting ready for a busy year, with the end of the transition period for the European Union’s Medical Device Regulation (MDR) fast approaching. After the May 2020 deadline, all new medical devices must meet MDR requirements in order to be placed on the European market. Meanwhile, existing devices that have already been certified under previous legislation will have to be recertified under the MDR by 2024.

In September, Berlin-based BIOTRONIK achieved the industry’s first MDR certification for a device in the highest-risk Class III category, after obtaining approval for its Renamic Programmer software. The company says the achievement comes down to a preparation effort dating back three years, but that challenges still remain to meeting MDR requirements in time.

The MDR replaced both the previous Medical Device Directive and the Active Implantable Medical Device Directive with a single regulation governing product certification across the EU. Although companies have until 2024 to recertify existing products, parts of the MDR remain open to wide interpretation, says Roman Borkowski, BIOTRONIK’s Senior Vice President, Quality Management and Regulatory Affairs, Cardiac Rhythm Management. This leaves open the question of how firms might have to adapt while the regulatory ambiguities are gradually clarified over the next few years.

- Roman Borkowski
The ‘MDR journey’ has only just begun and there’s still a long way to go. 
- Roman Borkowski

“The ‘MDR journey’ has only just begun and there’s still a long way to go,” he says. He points out that while BIOTRONIK agreed on a transition plan with its notified bodies earlier this year to recertify existing products, the firm anticipates it will have to use almost the full length of the transition period for legacy products that ends in 2024.


“Although manufacturers are preparing themselves as best as possible, complete guidance has not yet been published, many standards have not been harmonized, the majority of necessary implementation acts have not been adopted, and common specifications do not yet exist.” With the number of products that have to be recertified in addition to the new technologies companies will seek to launch on the European market, Borkowski predicts regulatory bodies may be heavily backlogged - especially towards the end of the transition period.

MDR implementation

So what can organizations do? Some firms are expected to pull certain existing products rather than recertify them. Borkowski recommends that companies do whatever they can do to prepare now with the information currently available. “The faster a manufacturer starts with the practical implementation of the known interpretations of the MDR, the easier it will be to adapt later and ultimately implement the necessary changes successfully in order to comply with the MDR,” says Borkowski.


BIOTRONIK began with a cross-department project in 2016 to first recertify its programmer software. They also focused on collaborating with numerous industry association working groups, across Europe, to get a sense of how the MDR was likely to work in practice. This helped to prioritize products, like the Renamic Programmer software, that are widely used but required less expert panel involvement to achieve certification.

Borkowski argues it is a harder result to duplicate in other products, “but we are prepared to fulfill the conditions required for recertification until 2024,” he says. “Many changes to legacy products will be limited during this time as any such changes, for example ones involving component availability, would require immediate certification under the MDR. But we are confident that the steps we’re taking will allow us to ensure a seamless continuity of supply during a challenging time for how we handle regulatory compliance.”