Equip course No EQ004: MDR (EU) 2017/745: An introduction

£360.00 incl. tax*

The new European Medical Device regulation is here. This 1 day course will equip attendees with the information required to embark confidently on their MDR journey. This course is an extensive overview of key aspects of regulatory compliance in relation to the MDR and will cover the following considerations:

  • Background to EU Legislation

  • Background and introduction to MDR

  • Manufacturer obligations

  • The MDR Quality Management System

  • EU MDR conformity assessment

  • The MDR Declaration of Conformity

  • Technical Documentation

  • Unannounced audits

  • Significant change

  • Authorised representative obligations

  • Registration/Eudamed

  • PRRC

  • Design change

  • Labelling / IFU

  • UDI implementation

  • Translation procedures

  • CE marking

  • Classification

  • PMS/PMS Plan

  • PMCF

  • Vigilance

  • Recalls

  • The role of the Notified Body

  • Control of outsourced processes

  • Training considerations



Course price includes:

  • Provision of electronic pdf copies of course slides

  • Listing of candidate on MedRAS Assurance register as auditable evidence of training completion


Course dates: The course runs once per month: available dates below.


Course location:  Online Via MS Teams: Please get in touch with us via the contact page to arrange bespoke group in person training.

Course price:  £300 excluding vat per person

Course price includes:

  • Provision of electronic pdf copies of course slides

  • Electronic certificate of course completion

  • Listing of candidate on MedRAS Assurance register as auditable evidence of training completion



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* Based on residence in United Kingdom. Tax rates for other countries will be calculated at the checkout. Price exclusive of tax: £300.00.