Europe
Previously we released an article dedicated to the regulatory framework for medical devices introduced under the Medicines and Medical Devices Act 2021 (the Act), the key element of the UK legislation on medical devices. The present article is dedicated to the...
Europe
The Medicines and Medical Devices Act 2021 (the Act), adopted on February 11, 2021, constitutes one of the basic elements of the UK`s legislation in the sphere of medical devices. The document outlines the rights and responsibilities of a Commissioner of Patient...
MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published guidance describing the registration process medical devices must go through before placing them on the market in Great Britain...
MHRA
The MHRA has published a draft Patient Involvement Strategy describing how patients and the public should be involved in processes related to medical devices and other healthcare products. Table of Contents It is important to mention that a similar policy was already...
Europe
The Medical and Healthcare products Regulating Authority (MHRA) has published a response to the report of the Independent medicines and medical devices safety (IMMDS) review. Report on Safety Review in Brief The review is based on the principle stating that the...
EU MDR/IVDR
The European Commission (EC), the medical device regulating authority of the European Union, issued a new regulation regarding standardization aspects in the context of Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation...
