Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

Medicines and Healthcare products Regulatory Agency

MHRA publishes guide to new EU medical device laws

The Medicines and Healthcare products Regulatory Agency (MHRA) has published an introductory guide for manufacturers to make sure their medical devices meet new European Union (EU) legislation.

The guide, designed as an interactive PDF, concerns new EU laws which will apply to medical devices, including digital devices, which are due to be introduced in May 2020. The guide also applies to changes in the law which will affect in vitro diagnostic devises from May 2022.

“We live in an increasingly digital world, and the way we provide our guidance is changing,” said John Wilkinson, MHRA’s director of medical devices.

“We want to help manufacturers to comply with the new regulations as easily and as early as possible.”

Under the new regulations, some products which have previously escaped regulation now fall under the EU legislation. These include dermal fillers, non-corrective contact lenses and brain stimulation devices.

The interactive document produced by the UK’s medicines safety watchdog is intended to support new and experienced manufacturers alike. The three- and five-year transition periods for implementing the changes are already underway having started on 25 May 2017.

The EU changes include making the supply chain more transparent and the introduction of a unique device identification (UDI) system and new standards for clinical evidence.

More rigorous reporting requirements, including new deadlines, are also being introduced and manufacturers will be given a clearer idea of their post-marketing surveillance responsibilities.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203476

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • BNF and BNF for Children

    BNF and BNF for Children

    Now available as a 1 year print subscription to both the BNF and BNFC, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £138.50Buy now
  • BNF and BNF for Children

    BNF and BNF for Children

    Now available as a 2 year print subscription to both the BNF and BNFC, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £262.50Buy now
  • Patient Care in Community Practice

    Patient Care in Community Practice

    Patient Care in Community Practice is a unique, practical guide for healthcare professionals or carers. Covers a range of non-medicinal products suitable for use at home.

    £22.00Buy now
  • Clinical Pharmacokinetics

    Clinical Pharmacokinetics

    A practical guide to the use of pharmacokinetic principles in clinical practice. Includes case studies with questions and answers.

    £33.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Supplementary images

  • in vitro diagnostic medical device

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.