New European Medical Devices Regulation (MDR)
The new European Medical Devices Regulation (MDR) just came into effect, with immediate application for new medical devices, generating an interesting debate. Some players welcome this major change which will align national regulations, and believe it will help to remove from the market several medical devices with limited evidence and quality control.
Others highlight that the lack of enforcement of the directives in the past rather than the gaps in regulations originated a critical situation and therefore the need for a new MDR. Still others argue that some of the new, more restrictive regulations might be detrimental to innovation. For example, the classification of most medical software has shifted to class IIa or higher, thereby putting many start-ups and medical applications under pressure.
Irrespective of any personal opinion with regard to this regulation, the more demanding reviewing processes are meant to ensure safer and more effective solutions to the patient’s health conditions.
As a non-exhaustive list of the key changes impacting our products and dossiers we can quote:
- Risk classification of devices and scope of the Regulations
- Clinical investigations and performance studies
- Obligations and regulatory requirements of economic operators
- Traceability
- Identification
- Labelling and instructions for use
You will be able to find a more comprehensive overview on the changes in the Factsheet for healthcare professionals and health institutions, published by the European Commission.
As a Swiss pharmaceutical company, it is our duty to meet some of the highest quality standards in the world and stay one step ahead. That is why we have taken a proactive stance towards being MDR compliant. Our OSTENIL® Line, focused on rheumatology and tendinopathy, received MDR approval and new registrations for OSTENIL®, OSTENIL® Plus, OSTENIL® Mini and OSTENIL® Tendon from the 1st semester of 2022.
In a similar fashion, although we still have a few years until the deadline to switch our VISMED® ophthalmology line over to MDR, our regulatory departments are working extensively to make sure our products will be ready for conformity assessments as well as seamlessly available on the European market.
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