We can perform a gap assessment on your current operational processes to see where you need to improve in order to comply. Call us today at (978) 358 7307, or just click here:
By now you've probably heard rumblings about the "EU MDR/IVDR". The EU, like any other geographical market, has its own set of regulatory requirements. These requirements were recently changed to the EU Medical Device and In-Vitro Diagnostic Regulations (EU MDR and IVDR) and are set to go into effect on May 26, 2021. This means that all medical device manufacturers have to comply with the new regulations by this date - and it's quickly approaching.
Now, it is true that about 85% of the MDR requirements are covered in the old MDD. However, even where the requirements are consistent, the MDR is actually more prescriptive in what evidence is required to demonstrate compliance. For example, are residual risks identified in your product risk profile represented in product labeling? This is a must under the new regulations.
Here are some things you should do in order to comply with the new regulations:
The new MDR changes the market access landscape for all member countries of the European Union, and it aims to ensure a higher level of protection for patients and users. Some key changes associated with the MDR include:
RQMIS offers the following services to help you with the EU MDR / IVDR transition:
We can perform a gap assessment on your current operational processes to see where you need to improve in order to comply. Call us today at (978) 358 7307, or just click here: