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Brilliant interactive MHRA Guide to MDR & IVDR

Sample of medical devices that can be covered by the MDR and IVDR

Much has changed in the interim but this Guide is still very relevant in 2021

On August 29th, 2017the UK’s MHRA has published an interactive guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation (IVDR).

If you still need to ‘get your head around’ the regulations, which are extensive, this is a great place to start.

The Guide covers …

  • Introduction & the Transition arrangements
  • Definitions
  • Classification of devices
  • Conformity Assessment
  • Placing a Device on the market
  • UDI (Unique Device Identifier) and Eudamed (European databank on medical devices)
  • Supply Chain obligations
  • PMS (Post-market Surveillance) and Vigilance requirements

 

NOTE: Contrary to general belief, the Guide states that Conformity Assessment by a Notified Body is NOT required for most Class 1 Medical Devices (as opposed to Class 1M or 1S) or Class A In vitro Devices. In these cases, the services of an ISO 13485 Certification Body plus a self-assessed Certificate of Conformity to regulations will be sufficient.

See the UK government's website for the detailed MHRA guidance or our post about US FDA Regulations for comparison.

Train your ISO 13485 Internal Auditors

A word of warning

The regulatory scene, whether EU, UK or USA, is ever-changing and, depending on which regulatory areas you are servicing the changes may continue to 2027 and beyond.  Consequently, you are advised to get up-to-date information from a regulatory expert before investing resources into new or changed medical devices.  Costs which previously were modest may now be such as to render a device economically nonviable. And the extent of the documentation that must be developed and submitted can be considerable too.

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deGRANDSON Global is an ISO Certified Educational Organization

InISO 21001 ISO 29993 ISO 29994 October 2021 we secured certification to three education-related ISO Standards.  We now have a university-grade management system in place conforming to the requirements of  …

  • ISO 21001, Educational Organizational Management System,
  • ISO 29993, Learning Services outside formal Education,  and
  • ISO 29994, Learning Services – additional requirements for Distance Learning.

We have chosen ISO 21001 certification because, unlike IRCA and Exemplar badges (which in our opinion are commercially compromised), it is based on independent third-party assessment.  It is a ‘university grade’ standard in use globally by schools, colleges, and universities to demonstrate their competence.

 

Written by Dr John FitzGerald

Director & Founder of deGRANDSON Global. Spent 15 years in the manufacturing industry and 25 years training, consulting & auditing management systems
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