New Medical Device Regulations
May, 2017
As new medical device regulations to monitor the sales, manufacturing, and distribution have come into force our friends at Markel have put together all the important information that you will need. Markel have identified the changes in the regulations and made it easier to read;
The 25th May 2017 marked the start of a transition period, in which companies have 3 years (for MDR) and 5 years (IVDR) to prepare for the following changes:
– Tighter controls on high risk medical devices; Class III and implantable medical devices will be subject to harmonised procedures relating to clinical evaluation, clinical investigation and mandatory post market clinical follow up and periodic safety update reports.
– Reclassification of certain high risk Class II devices to Class III. – Software which drives a device or influences the use of a device, falls in to the same classification of that device; if independent from the device it will be classified in its own right.
– Oversight of Notified Bodies moved from Competent Authorities to multi-national teams.
– Inclusion within the regulations of products without an intended medical purpose;
– contact lenses
– products used for modifying the anatomy or fixation of body parts (other than tattoo products or piercings)
– products for fat removal
– dermal/mucus membrane fillers
– lasers, intense pulse light equipment for skin rejuvenation
– products using electromagnetic fields to modify neuronal activity
– Creation of EU wide database of medical devices and device traceability via a Unique Device Identification system. – Strict liability on Authorised Representatives (AR) of non EU manufacturers, who will be jointly and severally liable with the importer and the manufacturer for defective products.
– No grandfathering; devices that do not comply with MDR/IVDR at the end of the transition period will not be able to be marketed.
– All organisations subject to the MDR/IVDR will be required to have a designated Qualified Person (QP) with at least one year professional experience in Regulatory Affairs or Quality Management Systems.
