The EU Medical Device Regulations will make it harder for new devices to be certified
Startups help bring new vision as they build their products or services based on innovative ideas. Starting a new company is never easy, but in the field of medical device development, it is even more complicated. Despite all the benefits they offer, medical device startups face a lot of challenges along the way due to a wide range of regulatory demands and requirements for staff qualification. However, the year 2020 promises to be the most challenging for these companies so far.
That is thanks to the new EU Medical Device Regulations (MDR) that were established in 2017. These regulations will finally come into full effect in May 2020. According to them, manufacturers of new devices must comply with a set of requirements in order to get their product certified.
First of all, the unique device identification system, which allows tracing medical devices, has been presented. Each device is required to have unique identification attached to the device itself or to its packaging. Moreover, if its components are considered medical devices on their own and can be bought on the market separately, they need to have individual UDI as well. This causes a lot of difficulties for manufacturers. For instance, if you compare the top medical alerts companies, you’ll see that they have a number of features and elements that can be used independently.
New regulations also enforce totally new rules that require extra work after the product has been developed and introduced into the world. Manufacturers must carry out post-market surveillance and incident monitoring to ensure that the product is performing as expected.
Additionally, any devices that comply with the previous medical device directives will not be legitimate any longer, as the certificates issued under these directives are going to expire four years after the new regulations become effective. It means that the existing products that are currently on the market are not exempt from the regulations as well and need to be recertified. What is more, the new regulations are not only applicable to various types of medical devices, but also to software that accompanies them.
Besides spending more time and effort on device development, another challenge for startups lies in increased resources. Companies will need to invest more money in order to perform more accurate and strict tests. Usually, these are biological, mechanical, and electrical tests. But all the verification procedures should match the specifications and regulatory requirements.
It is a real trial for new startups that have no prior experience with regulatory demands and, consequently, it may result in considerable delays or even cancellation of their products
What makes it all even more challenging for the startup companies is the fact that they need to be certified by foreign notified bodies, as they are not allowed to use those in their base country, which is even more costly and burdensome. Non-EU manufacturers of medical devices are required to have a European Authorized Representative in the EU, who will be responsible for verifying that all the technical documentation and required procedures have been carried out by the manufacturer. It is also worth mentioning that authoritative bodies who are responsible for certifying medical devices need to be re-approved as well.
With such demanding rules being enforced, not all medical device companies are going to survive. And it is even harder for new startups that are trying to get into the busy market, as introducing new products is not as easy as it was before. So it is possible that a lot of novel ideas will not be realized or at least will take more time to come to life.