For starters, MDR specifies that a Post Market Surveillance (PMS) plan must be part of the device’s technical documentation. Annex III provides a list of 10 topics that the PMS plan has to cover.
Companies must also use the European Data Bank on Medical Devices (EUDAMED) electronic system for all reporting to relevant Competent Authorities. Member states will analyze the data, and manufacturers are expected to analyze theirs as well. Transparency is a guiding principle of the new regulations, and the EUDAMED data will even be made public for some devices.
Adding even more complexity are new classification rules for medical devices. There are some new devices that weren’t previously classified, and they’ve also added new categories that will put some devices in a different level. So, manufacturers will want to carefully examine MDR classification rules in Annex VIII.
Each manufacturer also has to appoint a Person Responsible for Regulatory Compliance (PRRC). The MDR extends beyond device manufacturers to other supply chain resources as well, like distributors and importers who will now also have specific regulatory obligations.
That means manufacturers need to start considering their entire supply chain with regards to regulatory compliance. Agreements with EU Authorized Representatives (EUARs), if used, should be updated. One key is ensuring that your EUARs have defined plans to officially register and that they have enough insurance to cover their new liability.
