You have launched your product; do you know your responsibilities now?
A key requirement in the EU regulations for medical devices is an undertaking by the
manufacturer to institute and keep up to date a systematic procedure to review
experience gained from devices in the post-production phase (a.k.a. PMS) and to
implement appropriate means to apply any necessary corrective action. This undertaking
must include an obligation for the manufacturer to notify the competent authorities of
incidents immediately on learning of them.
Following the implementation of the current version of the MDD effective March 2010,
there has been increased emphasis on PMS; particularly proactive- and reactive- PMS.
Draft consolidated texts of the proposed MDR and IVDR contain further clarity on PMCF
Consequently, the responsibilities of manufacturers in relation to PMS have increased in
particular for Class III and implantable devices.
This webinar will help you to understand the requirements and consider your options to