Clearance to Market

Preparing, collating, reviewing, submitting and maintaining Technical Documentation to evidence safety & performance to meet national registration requirements such as EU (MDR, IVDR) CE mark, EUDAMED registration; MDSAP; US 510k application, UK Medical Device Regulations UKCA, UKNI mark and MHRA registration.

Acting as your designated UKRP for non-UK based manufacturers.

Preparing, compiling relevant safety & clinical performance data for your Technical Documentation / Device Files including Design and specification, Risk Management File, Clinical Evaluation, PMS Reports including:

  • Selection and Liaison with UK Approved Body and/or EU Notified Body where required

  • EU Medical Device (MDR) & IVD Regulation (IVDR) Annexes I, II and III Requirements and EUDAMED registration

  • UK Medical Device Regulations including UKCA, UKRP and MHRA Registration

  • Clinical Evaluation Plan(s) and Report(s) and PMCF

  • Risk Management Plan and Report.

  • Summary Technical Documentation as (STED)

  • Post Market Surveillance Plan, Post Market Clinical Vigilance / Reports, Feedback data analysis and Reporting.

  • Declarations to EU Harmonised  or National Standards with Statements of Conformity

  • Regulatory applications, notifications, submissions to regulatory authorities & registratons

Meeting specific national requirements, to successfully achieve national clearances, registrations, listings, or licensing as appropriate to your chosen territory.

  • Standard Operating Procedures
  • ISO 13485, 14971, CFR 820, device classification
  • ISO, AAMI, ANSI, EN, IEC Standards
  • CE, UKCA, UKNI
  • EUDAMED / MHRA Registrations / Listings
  • Economic Operator Registrations
  • EU  / UK Authorised Representative
  • EU Device Regulations (MDR and IVDR)
  • Technical Documentation
  • EU  / UK declaration of conformity
  • MHRA or Competent Authority Registration
  • UDI, EUDAMED Registration
  • National Applications / Registrations

Would you like to know more?

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