I believe that their is a huge risk to patient safety if products are not available between their CE certificate expiring and new MDR certificate being issued. Products are having to be temporarily withdrawn from the market as notifiable bodies are not able to keep up with the demands of assessing products through the more stringent MDR process with technical files to review etc and are significantly behind…
BPR Medical
Other · United Kingdom
not in the EU Transparency RegisterThis organization files on consultations without a register number, so its record here is built from its filings alone. Register facts — staff, costs, accreditations — are not available for it.
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Their record over time
BPR Medical filed 2 positions between 13 Jan 2023 and 17 Jan 2023, across 1 of the 583 legislative files tracked here.
What they argued
We believe that manufacturers with certificates that have already expired since May 2021 should be offered an opportunity for reinstatement with the caveats of no significant changes, PMS per MDR etc. In many cases the expiration is unavoidable by any means available to the manufacturer; they may not have had the opportunity for a transition audit yet or may have been unable to find notified body to accept them for…
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