EU MDR Gap Analysis
The first step any Regulatory Affairs or Quality teams takes is to (hopefully) read through the latest medical devices regulation and identify which components are missing to go from Old -> New for each of your medical devices.
In terms of the new EU Regulation (MDR), it’s likely that your Post Market Surveillance, Clinical Evaluation, and Bio-compatibility testing fall short. Fortunately, there are now several great templates and checklists available for helping you structure that medical device gap analysis.
Medical Device CER and Literature Search and Review
It’s almost guaranteed that your CER will need an overhaul to conform going forward. Expanded Literature Search is a major element of a new bulletproof MDR CER. Additionally, there is a noticeable move away from the ‘Essential Requirements’ list in Meddev towards the GSPR’s in MDR. You will need to restructure your CER to hit all of these new safety and performance requirements.
The CiteMed team is incredibly experienced drafting (and saving!) CERs for MDR. However, our real talents shine when it comes to delivering a comprehensive and modular Literature Review to be included within the CER. These literature reviews will leave your Notified Body Assessor with no doubt that you covered every possible angle when it comes to the safety and efficacy of your medical devices. It also addresses State of the Art in your device’s industry which has become increasingly scrutinized by Notified Bodies.
EU MDR Post Market Surveillance
Your medical device PMS plan will need to be bolstered in order to meet MDR standards. So far the regulations are very explicit about increased intervals of reporting and responsibilities…but they have not been as clear in stating the exact contents of each type of report. This creates a lot of uncertainty for medical device manufacturers.
Confusion around the various types of PMS reporting (Vigilance, Safety Update Reports, Clinical Followup) has inspired our team to write up an extensive guide to Post Market Surveillance (for manufacturers attempting to buy services from consultants). We have also given our Literature Review System an upgrade to be used when searching and compiling clinical data for your own reports. Check out our papers and if you have any questions about how we can help you nail PMS year after year (without spending much of your time or budget) then drop us a line.