Out now: A handy guide provides quick and simple insight into the world of medical device standards

11 February 2019

London-based medical device regulatory consultancy Quality First International has written a basic guide to the use of standards to demonstrate fulfilment of product specification, conformity with European regulations or specified requirements of medical devices.

Haroon Atchia, CEO and co-founder of the London-based medical device regulatory consultancy Quality First International, has written a basic guide that helps medical device manufacturers to establish the status of technical standards used in the medical device industry and how they may be applied, how to evaluate a standard and – perhaps most importantly – how to provide evidence necessary to demonstrate conformity and limits conferred.

Taken from introductory and intensive training courses developed by Quality First International, and systems, procedures and activities created and implemented for numerous client medical device manufacturers, it is hoped this basic guide can provide readers with quick and simple insight into the world of technical standards used in the medical device industry.

“The guide is presented in a question and answer format to reflect the types of questions commonly asked by medical device manufacturers during our training courses”, states Haroon Atchia. “In addition there are a few Q&As that are not immediately obvious to allow introduction and quick access to the subject.”

The guide has been published by Global Regulatory Press and may be purchased directly from their Bookstore, price: £65 (plus VAT as applicable).

Quality First International launches post-Brexit UK Responsible Person Programme for medical device manufacturers

19 February 2019

London-based medical device regulatory consultancy Quality First International now offers post-Brexit UK representation services that will become mandatory for medical device manufacturers located outside the UK.

The British medical device regulatory consultancy Quality First International has launched its UK Responsible Person Programme, which offers UK representation services for medical device manufacturers that are located outside the United Kingdom and who want to place or continue to place their products with the CE mark of conformity on the UK market after the UK’s exit from the European Union on 29 March 2019.

The UK Competent Authority, the MHRA, has advised that once the United Kingdom exits the European Union – with or without an agreement being reached between the two parties – manufacturers not domiciled in the UK must appoint a formal UK Responsible Person (UKRP) to be able to continue placing medical devices on the UK market.

The UKRP will act on behalf of such a manufacturer to fulfil obligations of the latter under Regulation 7A (Amendment of Part II of the 2002 Regulations) in the draft version of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

With its UKRP Programme, QFI offers the following services:

  • registration of medical devices with the MHRA
  • examination of conformity of products to standards required by the MHRA
  • notification of adverse incidents and other notifiable situations to the MHRA
  • serving as a legal entity and point of contact pursuant with the applicable UK Medical Devices Regulations 2002
  • ensuring permanent availability of technical documentation to the MHRA pursuant to the UK Medical Devices Regulations 2002

Medical device manufacturers interested in this service may contact QFI by email enquiries@qualityfirstint.com or telephone +44 (0)208 221 2361.