New Medical Device Regulations in Europe
How the new laws will change the health industry
28. April 2017
After four years of negotiation the European Parliament has passed a new European Medical Device Regulation (MDR) to enforce the quality and safety of medical devices within the European market. After a three-year transition period the new regulations becomes applicable in mid 2020, bringing new challenges for manufactures, named bodies and other companies and players within the industry to the surface. This involves extensive documentations and report obligations, which is relevant for all manufactures located within the European markets but will also become relevant for manufacturers and suppliers located in other countries.
As a result, training requirements will increase. Especially small and mid-sized companies within the health industry may be affected by these new regulations as they don’t have the financial or personnel capacities. E-Learning is an efficient and cost-effective solution for them to meet the new training demands.
In Germany and Austria the regulations for medical product consultants is clearly defined by the law. It is mandatory for consultants to document and provide proof of knowledge about new regulations on a regular basis. IMC AG offers off-the-shelf online courses for medical product consultants, exactly for this purpose. These online courses are available time and location independent, making the learning of the regulations for medical devices suitable for the individual needs of the learner. The standard content for medical product consultants is available in German only but can be individually transferred into several languages on request.
Source: European Commission