Chapter 4 - nicotine dose guidance Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to test and report levels of nicotine uptake when submitting a notification of intent to market e-cigarette and vape products. 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 16, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Chapter 3 - emissions guidance Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The types of emissions a manufacturer or importer of e-cigarettes should notify us about. 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
Chapter 1.1 - submission type guidance Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Which submission type to select when submitting a notification of intent to market e-cigarette and vape products in 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 16, 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
Regulation of devices in Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Information about the EU Regulations and their implementation in Northern Ireland 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 March 25, 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
The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations make amendments to the Medical Devices Regulations 2002 (“the 2002 Regulations”), the Blood Safety and Quality Regulations 2005 (“the 2005 Regulations”) and the Medical Devices (Northern Ireland Protocol) Regulations 2021 (“the 2021 Regulations”). They also revoke and restate the… 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 March 27, 2023 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Chapter 9 - General advice on due diligence Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 General advice on due diligence - electronic cigarettes devices and refill containers. 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 on March 23, 2022 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Chapter 2 - Product Type Guidance Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Submission of notifications for Northern Ireland under article 20 of directive 2014/40/EU. 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 on March 23, 2022 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Chapter 10 - General Advice on Vigilance - Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 General advice on vigilance - electronic cigarettes devices and refill containers. 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 on March 23, 2022 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
Guidance for retailers: supplying medical devices to Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How the supply of medical devices from Great Britain into Northern Ireland works. 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 March 5, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Operation of the health institution exemption (HIE) – IVDR and MDR (Northern Ireland) From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The EU has published guidance on exemptions for medical devices manufactured and used within EU health institutions, which applies to Northern Ireland-based health institutions, replacing interim guidance from the MHRA. 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 January 1, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Health and Safety (Medical Devices) Regulations (Northern Ireland) 1996 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Regulations for medical devices (Northern Ireland, 1996). 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 March 19, 1996 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites