Export medical devices From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Order a certificate of free sale to export medical devices outside the UK. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 2, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Medical devices: UK approved bodies From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 2, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
COVID-19 test approval: how to apply From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How test manufacturers or distributors can apply for approval of their tests to sell on the UK market. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 24, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
The Innovative Devices Access Pathway (IDAP) From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 29, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (“Regulation… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 22, 2024 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Regulating medical devices in the UK From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 8, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Apply for a traditional herbal registration (THR) From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on January 5, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Dialysis guidance From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 This guidance has been produced in collaboration with the UK Kidney Patient Safety Committee (KPSC), to summarise known safety issues with dialysis and continuous renal replacement therapy (CRRT) and describe what to do to minimise or prevent serious injury. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 21, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
How to draft a direct healthcare professional communication From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs) Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 4, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
More information about the MHRA From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 16, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Risk-Adapted Approach to clinical trials and Risk Assessments From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on January 28, 2022 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Information about BIA-ALCL for people with breast implants From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 This advice has been written by the Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG) at the request of the Medicines and Healthcare products Regulatory Agency (MHRA – UK regulator). It is in the form of questions, asked of clinicians in consultation with their… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on December 13, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), 'grandfathering' and managing lifecycle changes From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on October 15, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Guidance on regulatory classification of point-of-use hospital water filters in the UK From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The MHRA position on the appropriate classification of point-of-use water filters for the UK market, and advice for suppliers and procurers of these products Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on October 1, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Access to Electronic Health Records by Sponsor representatives in clinical trials From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on September 8, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Infrared (IR) thermometers: caution in use From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The MHRA has become increasingly aware of infrared thermometers being sold in the UK that do not comply with the regulations. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 27, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
The Medical Devices (Northern Ireland Protocol) Regulations 2021 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 27, 2021 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
The Yellow Card scheme: guidance for healthcare professionals, patients and the public From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Details of the Yellow Card scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 1, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations are made in exercise of the powers conferred by section 8(1) of, and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 2018 (c. 16) (“the Withdrawal Act”) in order to address failures of retained EU law to operate effectively and other deficiencies (in particular… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 9, 2020 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations are made in exercise of the powers conferred by section 8(1) of , paragraph 7(2) of Schedule 4 and paragraph 21 of Schedule 7 to the European Union (Withdrawal) Act 2018 (c. 16) (“the Withdrawal Act”) in order to address failures of retained EU law to operate effectively and… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 26, 2020 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites