As most of the world seems to be at a standstill this week, the European Commission published new guidance (MDCG 2020-3) to further define “significant change” requirements under the new Medical Device Regulation (MDR) policies coming our way on May 26, 2020.
The highly anticipated guidance provides medical device manufacturers and Notified Bodies (NB) with flowcharts to determine if devices currently covered by certificates under Medical Device Directive (MDD) or the Active Implantable Medical Device Directive (AIMDD) should consider a change in their medical device as significant when transitioning to MDR under Article 120(3).
R&Q experts found that the new flowcharts are helpful in terms of identifying which medical devices would qualify as a significant change, though the guidance would benefit greatly by providing specific examples of changes to help interpret the flowcharts.
The European Commission reiterates that no new certificates will be issued as a result of changes and that the Notified Bodies (NB) may choose to assess a change and, subsequently, issue a letter that will document that the change was not deemed a significant change. Manufacturers are then required to maintain the letter.
According to the new diagrams, the EU MDR transitional provisions consider significant changes as:
Chart A: Change in the intended purpose
o Extension or change in intended purpose
o New user or patient population
o Change of clinical use (e.g. new anatomical site)
Chart B: Change in design or performance specification
o Needs new clinical data to support
o New risks that require control measures
o Change in built-in control mechanism, operating sources, source of energy or alarms
Chart C: Software chart
o New or major change to operating system
o Modified architecture or database structure, algorithm
o User input replaced with closed loop algorithm
o New diagnostic feature or new channel of inter-operability
o New user interface
o Not a minor change
Chart D: Change in material
o Change includes human/animal origin
o Medicinal substance impacted by change
o Ingredient from new supplier with new specification
Chart E: Change in sterilization or packaging design that impacts sterilization
o New sterilization method
o Design change impacts sterilization
o Package design impacts sterilization
o Extension of expiry without prior NB review of methodology
Meanwhile, the following changes are considered acceptable under the transitional provisions:
- Change in Authorized representative
- Change in manufacturers name, address or legal form (legal entity remains)
- New manufacturing sites
- Subcontractor, supplier changes
- QMS changes (with limits)
o Correction of an error with no safety risk
o Appearance of the user interface
o Enhancements in user interface
As always, if there are questions on the guidelines ask your Notified Body (NB). R&Q experts are here to help you navigate the difficult road ahead with ample virtual content and experts on hand so don't hesitate to reach out to your R&Q representative and contact us today.
European Commission. “MDCG 2020-3: Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD”. Document date 16 March 2020. Accessed 18 March 2020. https://ec.europa.eu/docsroom/documents/40301
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