The regulatory landscape for medical devices is presently very challenging.
Industry is well aware that the 3 year transition period from a directive to a regulation ends on the 15th of May 2020, whereupon the new regulatory framework (MDR) will apply in full. This will be followed in May 2022 with the new IVD regulations.
This EU factsheet provides all the details
Re-certification work to MDR by the Notified Bodies is underway, however, there are significant capacity constraints in the system. This situation has not been helped by the decision by Lloyd’s Register Quality Assurance Ltd. (LRQA) to withdraw from providing notified body services for medical devices. Companies affected by LRQAs decision have been given 90 days notice to make alternative arrangements.
Medilink has been in conversation with the Governments Office for Life Sciences and we understand that the Medicines and Healthcare Products Regulatory Agency (MHRA) are liaising directly with companies who are affected by the LRQA withdrawal with a view to providing them with immediate support.
Within this difficult climate, Medilink would like to understand if there are any particular difficulties you are experiencing so we can try to help you get the right support; particularly if there is a specific issue being experienced by many of you. For example:
Have you been affected by LRQAs decision to withdraw? What is your experience so far in trying to source an alternative NB? Are there any specific questions you have that you can’t get answers for?
Whether you are affected by the LRQA withdrawal or not, are you confident that you are properly prepared for the changes to the Medical Devices and In Vitro Medical Devices regulations? Are there any key issues you are encountering? Is the support available to you sufficient?
Please email email@example.com if you would like to discuss any of the points and questions above, or indeed if you would like to make us aware of anything else you are presently experiencing/concerned about with regards regulatory matters, and we will try to help as best we possibly can.