23 Aug REGULATION CHANGES IN MEDICAL DEVICES – Q&A
Impact of Brexit ?
Regardless of the outcome of Brexit, MDR and IVDR will be implemented over the next 2 and 4 years. The new MDR (2017/745) and IVDR (2017/746) will replace the EU’s current MDD and IVDD.
Advantages of new regulations?
The MDR will improve clinical safety and fair market access for all medtech players – regardless of size. The MDR will be a more transparent, robust and sustainable regulatory framework.
The framework will ensure more effective protection of patient safety whilst continuing to support innovation. Post–market surveillance will also strengthen.
Who is affected?
The UK Medicines & Healthcare Products Regulatory Agency (MHRA) estimate half a million devices under CE Marked directives will need to fully comply with new regulations.
There is greater emphasis on reviews by Notified Bodies to confirm manufacturers are fully compliant and have all the supporting documentation for restrictive devices.
The IVDR implementation will see higher levels of workloads hence the longer transition periods.
Why manufacturers need to be prepared?
a) The will be large amounts of works for consultants and in-house professionals involved in preparation work
b) Some Notified Bodies are currently advising they are not providing CE Mark quotations for new clients
c) Notified Bodies are quoting lengthy lead times creating a bottle neck for certification completion
d) New procedures need to be implemented by manufacturers as there will be unannounced inspections as part of the regulations
e) The talent shortage for experienced personnel increases as we draw closer to the deadline. With increased demand creates competition for the same talent pool which unfortunately creates bidding wars
What organisations should be asking themselves?
Do our C-suite understand the transformation impact?
Is MDR on all business units agendas’?
Do we know the revenue impact of MDR and impact of late submission?
How many Quality Management Systems do we have in place?
Do we have Regulatory Leads in place?
Opportunity for competitive market advantage?
Brand – Compliance with the new regulation, with its focus on public safety, will enhance companies’ standing as a trusted partner
Early Market Advantage – The MDR compliance pioneers will be in a position to service market requirements as late movers will not be certified to service.
Strengthen Long Term – Early pioneers will not only take market share but leave late movers unable to win back lost market share
Competitive Positioning– Some organisations will adopt different strategies in response to new legislation, based on their capacity to make extensive changes. This leads to potential market expansion and/or acquisition targets.
Product Optimisation – with the new regulation, organisations will be examining the impact the regulation has on profit margins / new product design / new manufacturing processes and new supplier agreements.