“Earlier the law was mainly focused on avoiding the risk of injury – today the focus also lies on clinical utility”
The new regulations for medical technology devices (MDR) will be applied on May 26th. The law sets a higher demand for transparency and clinical evidence, meaning that earlier directives are now European law. This also means that the same regulations apply to all European countries. To increase the transparency for companies in the Medtech sector, the European database Eudamed was created. In the database, companies can store documentation about their medical technology. Information that is then made public and available to everyone.
– The regulations are clearer, and many earlier guidelines are now law. There are demands for aftermarket follow-up, user-friendliness, and the clinical aspect is stricter and more distinct. There must also be evidence that the product is clinically useful and that it is systematically documented, says Kristina Hallström, Clinical Affairs Manager at Care of Sweden.
MDR became effective in 2017 but was not applied until May of 2021. This gave companies time to adapt to the new law. For the past two years, Care of Sweden has worked to concretize what the law entails.
– Product evaluations are even more important now to make sure that the products are safe for the user throughout the whole life span of the product, says Susanne Andersson, Chief QA and Compliance Officer at Care of Sweden.
In addition to higher demand for product evaluations, the new law has also made requirements for market follow-up and clinical evidence clearer than before.
– Before the focus was mainly on risks, today the focus also lies on clinical benefits. There are also increased demands for regular product audits to make sure that they are still relevant according to new findings, says Kristina Hallström.
Kristina and Susanne both see the new law as being beneficial for the organization. Today, more departments are involved in clinical work, with a focus on assuring the quality of the products. MDR has made it clear what rules need to be followed, and the general regulatory competence has increased in all departments of the organization.
– The law is noticeable wherever you work in the organization and all employees have good knowledge about MDR today, Susanne adds.