Knowledge Base
Frequently Asked Questions
Practical answers from regulatory experts. Can't find yours? Contact us — we reply within 24 hours.
EU MDR & CE Marking
Typically 9–18 months for Class IIa/IIb devices including notified body review. Class III implantables can take 18–24 months.
Quality Management (ISO 13485)
Practically yes — MDR Article 10(9) requires a QMS, and ISO 13485:2016 is the recognised harmonised standard.
Clinical & Post-Market
Not always — for many devices, equivalence with literature data and PMCF is sufficient. Class III and implantables usually require clinical investigation.
US FDA
No. 510(k) is 'clearance' based on substantial equivalence to a predicate. PMA is full 'approval' for Class III devices.
Working with MEGACERT
Yes — mutual NDA before any technical conversation. ISO 27001-aligned data handling.