Guidance and regulation

What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 8 February 2024

The MHRA have published a roadmap which outlines the intended timelines for delivering the future regulatory framework for medical devices.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 28 March 2024

• Implementation of the Future Regulations

  1. Implementation of the future regulations The government intends to…

Submissions related to human medicines need to be submitted directly to the MHRA.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 4 May 2021

Pharmacovigilance system requirements

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 17 November 2023

Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 16 April 2024

A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 22 December 2021

UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 23 April 2024

How to use this new procedure for medicines licensing applications.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 8 April 2024

How the MHRA processes variations to Marketing Authorisations (MAs)

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

This guidance summarises our approach to pharmacovigilance

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 28 October 2022

The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

Importing investigational medicinal products for use in clinical trials

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 22 December 2021

Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 22 February 2021

This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

Submission dates and how the submissions using the EC decision reliance procedure work.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 12 September 2023

What you need to do to supply authorised medicines from Great Britain to Northern Ireland.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 23 January 2023

How to prepare for implementation and compliance of the Safety Features Regulation.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 14 November 2022