Since the foundation of LIME, we have been working on improving hand therapy with intelligent technology. The certification of our AnyHand is one of the biggest steps in this direction: After several labour-intensive phases, we are now allowed to mark AnyHand with CE. The certification is the last big step before entering the market, because patients in Europe may only be treated with a certified medical device.
What does the CE say?
The Conformité Européene, the European Conformity, confirms that AnyHand is a safe product according to the legal standards of the European Union and can also fulfil its medical-technical purpose. To achieve this standard, the MDD (Medical Device Directive), has been our daily companion for two years.
Why was the certification so labour-intensive?
We had a tough deadline to submit the product file for testing: In May the MDR (Medical Device Regulation) will replace the MDD, but the Notified Bodies only accepted technical documentation for the MDD until October 2019. Since the development of AnyHand was based on the MDD from the very beginning, the adaptation to the MDR would have been a great challenge. For this reason, the question at the beginning of 2019 was: is it possible to meet this deadline? No question for LIME’s team: "The entire team really gave everything and showed full commitment, especially in the final spurt before the file was submitted. This was the only way we could finish everything in 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 directive has recently been postponed by 12 months.
The CE marking is the start for the use of the AnyHand in clinics and hand therapy practices. The previous expressions of interest by doctors and therapists can now be converted into purchase agreements, so that the first patients can benefit from the intensified exercise therapy before the summer is out - a success we have been working towards since 2016!
We hope that we will soon be able to toast this unique milestone with our friends, families and partners as soon as current circumstances allow it. Until then, we would like to take this opportunity to thank everyone who has supported us on our way to the CE!