© Terraplasma Medical

Things Startups Should Think About During Medical Device Approval

The medtech startup Terraplasma Medical was still right at the beginning of the approval process for a medical device in the summer of 2017. Now the founders have finally received approval and all of the certificates necessary for their medical device. Find out more about the lessons the startup learned in our interview with CEO Jens Kirsch.

With the medical device known as Plasma Care, wounds can be treated with cold atmospheric plasma. Thanks to its completed approval, doctors and caregivers will now be able to use the handy, battery-powered device on patients. The approval process for a medical device is strictly regulated and was much lengthier than anticipated.

Getting approval for a medical device: Lessons learned? Challenges?

Munich Startup wanted to find out from founder Jens Kirsch how he dealt with the many challenges faced during the approval process. It was the EU-wide Medical Device Regulation, which was new at that point with its introduction in 2017, that made things particularly difficult for Terraplasma Medical.

Jens, what were the biggest challenges you faced during the approval process?

The effects of the Medical Device Regulation are now being felt quite strongly in the entire medical technology industry. Especially slow accreditation from ‘designated bodies’ (government authorized accreditation bodies, note from editor) leads to dramatic resource bottlenecks. The German Federal Government is even insisting on longer transitional periods and is no longer ruling out a shortage in the supply of medical devices. Of course, we also felt these effects first hand during the approval process for our new medical device Plasma Care. We couldn’t make progress as quickly as we had hoped.

Step by step: ISO certificate, safety tests and CE conformity

Which steps were most important for getting approval?

The most important step, in addition to the certification of our quality management system according to EN ISO 13485 (the standard determines the requirements for a quality management system for the design and manufacturing of medical devices note from editor), was preparing and reviewing the technical documentation.

That required an extensive and sound clinical evaluation of Plasma Care as well as several safety tests in accredited test laboratories. Factors such as electrical safety, electromagnetic compatibility and biocompatibility are tested.

Then our designated body issued all of the necessary certificates in June, which allowed us to successfully complete the CE conformity assessment procedure. That means Plasma Care can now be sold in Europe and used by medical professionals for treatment.

Bottlenecks worse than expected in the worst case scenario

Is there something where you now say to yourself: I wish I had known that back then?

That the resource bottlenecks caused by the new medical device regulation would be even more serious than expected in our worst case scenario.  Also the fact that until the start of the clinical study, extremely lengthy administrative processes in the administrative bodies of the study centers involved would have to be overcome. The auditing of contracts there can easily take six months or more.

“Take more time”

What advice would you give to other founders who want to get a medical device approved?

Especially in the coming years during the transition from MDD (= Medical Device Directive) to MDR (=Medical Device Regulation) plan on needing a lot more time for technical tests and reviewing the technical documentation than in recent years.

It is extremely critical for startups to know that most designated bodies are officially no longer accepting new customers at the moment. It would be best to prepare an approval strategy as early on as possible with a quality management or regulatory affairs consultant and to get in touch with an appropriate designated body, ideally one where you already have a contact person.

Thank you for sharing your experience with us.

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