decisions by different E.U. member states will be
reduced, as the commission is given new powers
to determine whether a specific product should
fall within the scope of the MDR/IVDR.
Post-market clinical surveillance
By the end of the transition period, every manufacturer’s post-market surveillance system must
include a post-market clinical follow-up (PMCF),
or, for IVD medical devices, a post-market performance follow-up (PMPF), to continuously update
the clinical evaluation of the device, reflecting current non-binding MedDev guidance. For implant-able and class III devices, manufacturers must draw
up a “summary of safety and clinical performance”
that will be validated by a Notified Body and made
publicly available. Manufacturers must review their
systems against the new MDR/IVDR, implement all
new requirements, and train their staff.
Supply chain control and traceability requirements
The new regulations will demand much greater
supply chain control. Notified Bodies will want to
see evidence of a mechanism for quick access to
pertinent technical data from suppliers and contract service providers during audits. Traceability
has been emphasized in this new guidance and a
Unique Device Identification (UDI) program must
be implemented to allow any medical device to be
identified and traced through the supply chain.
Each participant in the supply chain, including
distributors and importers, will have their own
regulatory responsibilities. The UDI, along with a
significant amount of data pertaining to vigilance
and post-market surveillance, will be entered into
an enhanced European Databank on Medical
Devices (EUDAMED) and made publicly available
to enable better-informed decisions of stakeholders.
The new MDR and IVDR are significant departures from the historical directives they are replacing. The changes do not grandfather programs and
will become law across all member states at the
end of the transition period. Currently approved
products and new submissions must consider the
implications of these new regulations now during
the transition period in order to be ready to align
their programs with these new regulations.
Bikash Chatterjee is President and Chief Science
Officer of Pharmatech Associates, a Hayward Calif.-based company that provides consulting and services
to the regulated life science industry. Bikash has been
involved in the biopharmaceutical, pharmaceutical,
medical device, and diagnostics industry for over 30
years. His expertise includes site selection, project
management, design, and validation of facilities for
U.S. and European regulatory requirements.