For those who have been following the EMA and FDA changes in IVD and LDT regs the past few years, MHRA is now proposing changes to its regulations.
MHRA has opened a public consultation on "Medical Devices Regulations: Routes to market and in vitro diagnostic devices". The revisions proposed include 4 review pathways and 4 new risk categories. The revised pathways include approached for US, EU, Australian and Canadian approved devices but specifically exclude two types of US approved devices:
• software as a medical device that has gained access to the USA market via the FDA 510(k) clearance process
• devices that comply with 510(k) legislation in the USA that are classified in GB as Class IIb implantable (excluding the devices listed in Route 4) and Class III
The Consultation document includes a few Q&A sections.
To download the Consultation document and the response form, go to:
https://www.gov.uk/government/consultations/consultation-on-medical-devices-regulations-routes-to-market-and-in-vitro-diagnostic-devices
#MHRA #IVD #Consultation
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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