Get ready for an active fourth quarter in the European Medical Device Regulation (MDR) world! We sat down with R&Q's Nancy Morrison, Executive Director of Regulatory and Quality Consulting Services, to get her thoughts on the newly released "Ongoing Guidance development within MDCG Subgroups" document from the European Commission.
According to the list published on October 25, there are 18 deliverables still planned for the remainder of 2019 that should provide more information on how the MDR will be implemented. There are, however, still some important topics that appear to be in the early stages such as the definition of a significant change and post-market surveillance (PMS) requirements where a task force still needs to be established.
Additionally, one significant missing item that would be especially helpful to R&Q Solutions clients is a template for the creation of Periodic Safety Update Reports (PSUR). As we gain experience in creating EU MDR compliant quality systems and technical documentation these guidance documents will provide a valuable check to ensure our work to date has been meeting the intent of the regulation. It always feels good to get validation for all the hard work that has gone into getting ready for May 2020!
Here is what we can expect regarding EU MDR & IVDR guidance in the last two months of 2019:
- Template PMCF Plan
- Market Surveillance for Class I devices
- Clinical evaluation of software
- UDI: Integration with QMS, Guidelines on specific product types (working with the US), formats of AICD and HRI parts of UDI Carriers
- Classification of IVDs
- Nomenclature: Information package on EMDN for a website, list of EMDN codes for implant cards
- Multiple clinical investigation guidance documents
Hot topics notably missing from the 2019 guidance deliverables:
- Definition of significant change (task force to be set up)
- CER: Equivalence (under consultation)
- CER: Legacy medical devices (under consultation)
- PMS Requirements (task force to be set up)
- Vigilance requirements (task force has been set up)
- Vigilance reporting forms (on-going work)
- Classification of medical devices (NET involved in drafting)
- Mapping CND-GMDN (Q2 2020)
- Qualification of Annex XVI devices (non-medical purpose)
Our consultants and clients will look forward to the clarity that the ongoing guidance from the European Commission will provide. Looking at the guidance that has already been issued, such as the SSCP guidance document, provides valuable clues in how EU MDR compliance will be assessed, such as the expectation for quantified risk and performance data.
Looking for more EU MDR and IVDR resources? Say hello to your expert implementers:
- Register for Free Webinar: Solving the EU MDR Labeling Puzzle | December 17
- Link to EU MDR Frequently Asked Questions