Why not give the EU Commission some feedback on their communication and the new MDR extension The objective of the online survey is to better understand the information needs around the EU Regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR). particularly…
News
The EU Commission’s Q&A
The EU Commission’s Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices that were released in July has a handy…
The European Commission published
On 18 July, the European Commission published in the Official Journal of the European Union an updated guideline made up of Questions and Answers on the practical aspects related to the implementation of Regulation as they relate to the SCOPE OF THE EXTENSION OF THE…
SA8000 training course
Check out our next SA8000 training course dates for London UK https://lnkd.in/dHaHDBS
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA)
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) embeds Global Medical Device Nomenclature (GMDN) in Public Access Registration Database (PARD) for Enhanced Medical Device Regulation. https://lnkd.in/eVGehWFw. In a significant development for medical device regulation, the Global Medical Device Nomenclature (GMDN) has joined forces with…
The Medicines and Healthcare Products Regulatory Agency (MHRA)
The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom announced the launch of its comprehensive Public Assessment Report Database (PARD). With PARD, individuals, healthcare professionals, and researchers can now easily access a wealth of information about medicinal products, fostering transparency, informed decision-making,…
The MHRA has Published a Statutory Instrument
The MHRA has Published a Statutory Instrument to Extend Timelines for Certain Devices Compliant with EU Legislation They have also given a useful infographic setting out the dates for IVDs and Medical Devices. https://lnkd.in/ef4v6Pfd
Medicines and Healthcare products
The Medicines and Healthcare products Regulatory Agency (MHRA), in conjunction with the National Institute for Health and Care Excellence (NICE), Health Technology Wales (HTW) and Scottish Health Technology Group (SHTG) will initiate a new regulatory pathway set to support safe patient access to innovative medical…
Office for Product Safety and Standard’s
The Office for Product Safety and Standard’s new UKMCAB service is now LIVE. You can access the service by visiting the following new web address. https://lnkd.in/ey2Z4xK3
Virtual manufacturing of medical devices
On 17 May 2023 The MHRA Updated its Guidance Virtual manufacturing of medical devices. It has some useful information about the documentation required and the responsibilities. https://lnkd.in/d6sHDTM