We will be publishing our 2nd MDR whitepaper ‘Be Prepared’ in October. You can sign up to receive a copy before it is available on general release. The second whitepaper will look at 5 areas that will impact device manufacturers and distributors.
‘Be Prepared’ will look at issues such as:
Overview of UDI (Unique Device Identifier system)
Quality Management System under MDR
An overview of Eudamed
Clinical investigations under MDR
Clinical evaluations under MDR
MDR has been dogged by issues, particularly the delay in appointing Notified Bodies. Italy’s IMQ became the fourth Notified Body to be appointed (along with DEKRA, TUV SUD and BSI) in recent weeks. The pace of appointing NB’s has alarmed some in the industry and has led to calls for the delay to the implementation of MDR in May 2020. Despite the clamour to delay implementation, the date has not yet changed and MDR will come into force on May 26th 2020. Companies need to be ready.
Sign up to receive your advance copy of the 2nd MDR whitepaper by completing the form. Also, below, you can find the details of our medical devices team should you need to contact them to discuss any MDR related issues that your company might have.
Do You Have MDR related Issues?
If so, contact Orla Keane, Acorn Regulatory’s Medical Devices Manager at 00353 52 61 76 706 or email: email@example.com