MHRA Strategy for Improving Safety Communications From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The MHRA’s strategy for Improving Safety Communications for 2024 to 2027. Metadata quality: Metadata quality: Data description empty 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: 44.44444444444444/100 Updated 2 days ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
MHRA consultation on statutory fees - proposals on ongoing cost recovery From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Consultation on proposals to update the MHRA's statutory fees to ensure they continue to recover their costs. 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 1 week ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Notify MHRA about a clinical investigation for a medical device From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices. 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 2 weeks ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
E-cigarette and Vape Advice for Retailers / Producers From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The MHRA provides advice for Retailers and Producers of e-cigarette / vape 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 August 16, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Pre-submission Advice & Support From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations. 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 August 13, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Register medical devices to place on the market From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland 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 August 2, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Guiding principles: Predetermined change control plans for machine learning-enabled medical devices From Health Canada 🇨🇦 FDA, Health Canada and MHRA jointly identified 5 guiding principles for predetermined change control plans, drawing upon GMLP guiding principles, particularly stating that deployed models are monitored for performance and re-training risks are managed. 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 29, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Good clinical practice for clinical trials From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection. 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 22, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Common specification requirements for in vitro diagnostic devices From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices. 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 21, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Medical devices regulations: compliance and enforcement From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Information on MHRA's enforcement duties and how to report a non-compliant medical device. 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 May 17, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Send and receive information on adverse drug reactions (ADRs) From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine. 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 May 9, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Contact MHRA From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to contact MHRA for specific services or enquiries. 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 April 26, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Borderline products: how to tell if your product is a medicine From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How the MHRA makes decisions on what is a medicinal product (borderline 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 January 8, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
MHRA fees From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Fees payable to the MHRA for 2023 to 2024 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 November 20, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
MHRA phase I accreditation scheme From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to join the phase I accreditation scheme. 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 November 10, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
How tests and testing kits for coronavirus (COVID-19) work From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The different types of tests and testing kits for COVID-19, and the specifications for manufacturers. 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 August 8, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Borderline products: how to tell if your product is a medical device and which risk class applies From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device. 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 11, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Software and AI as a Medical Device Change Programme From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, including artificial intelligence (AI). 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 14, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
MHRA / HRA Coordinated pathway From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The Coordinated pathway process resumed Monday 22 May 2023. 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 June 9, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
MHRA Innovation Office: guidance and support From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 We can provide access to world-class regulatory knowledge, expertise and experience from within the MHRA. 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 26, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites