by Federica Secchi | Aug 26, 2019 | Blog, MDR Medical Device Regulation
Medical Device Classification in the EU MDR One of the first considerations for medical device manufacturers who are seeking to place their products in the European market is to determine which is the appropriate classification for their devices. The classification...
by Federica Secchi | Jul 29, 2019 | Blog, MDR Medical Device Regulation
The Role of a PRRC (Person Responsible for Regulatory Compliance) in the EU MDR The New EU MDR that will go into effect in May 2020 requires medical device companies to appoint a Person Responsible for Regulatory Compliance (PRRC). The PRRC does not replace the...
by Federica Secchi | Jul 7, 2019 | Blog, MDR Medical Device Regulation
The MDR Countdown The new EU Medical Device Regulation (MDR) will create a robust, transparent, and sustainable regulatory framework, recognized internationally, that improves clinical safety and creates fair market access for manufacturers. Manufacturers need to...
by Federica Secchi | Jun 16, 2019 | Blog, MDR Medical Device Regulation
Will Your Notified Body Be Ready for Your EU MDR Certification? With the May 26, 2020 enforcement deadline for compliance with the Medical Device Regulation (EU MDR) approaching and the uncertainty of Brexit, medical device manufacturers and regulatory professionals...
by Federica Secchi | Jun 5, 2019 | Blog, Certification, MDR Medical Device Regulation
ECM’s Milestone Towards New Medical Device Regulation (MDR) 2017/745 Certification Medical device manufacturers are now focusing their attention on their transition plans to the new MDR regulations which becomes mandatory on May 25, 2020. In addition, some...
