Since the founding of LIME, we have been working to improve hand
hand therapy with intelligent technology. The approval of our
AnyHand is one of the biggest steps we have taken in this direction.
work-intensive phases, we have now received the CE mark and are allowed to
the AnyHand with immediate effect. The certification is the last big step
before entering the market, as patients in Europe may only be treated with a
be treated with a certified medical device.
What does the CE say? The Conformité Européene , the European
conformity, confirms that the AnyHand is a safe product according to the legal standards of the
standards of the European Union and that it is also able to fulfil its
medical-technical purpose. To achieve this standard
the Medical Device Directive 93/42/EEC, also called MDD (Medical Device
Directive), has been our daily companion for two years.
Why was certification so labour-intensive? To submit the product file for review, we had to meet a hard deadline: In May, the MDR (Medical Device Regulation) replaces the MDD, but the Notified Bodies only accepted technical documentation for the MDD until October 2019. Since the development of AnyHand had been guided by the MDD from the beginning, adapting to the MDR would have been a major challenge. Therefore, at the beginning of 2019, the question was: is this feasible in terms of time? For the LIME team, no question: "The entire team really gave their all and showed full commitment, especially in the final spurt before the submission of the file. This was the only way we could finish everything on time. The hard work at the end of last year has now absolutely paid off," says founder Pascal. Due to the Corona pandemic , the entry into force of the new policy has recently been postponed by 12 months.
What happens next? The CE marking is the starting signal for the use of the
AnyHand in clinics and hand therapy practices. The previous
expressions of interest from doctors and therapists can now be converted into
so that the first patients can benefit from the intensified movement therapy this summer.
intensified movement therapy - a success we have been working towards since
have been working towards since 2016!
We hope to be able to toast this milestone with our friends, families and partners soon.
partners to this unique milestone as soon as current circumstances allow.
circumstances allow. Until then, we would like to take this opportunity
all those who have supported us on the way to the CE!
