By

Maria Isabel Manley

22 September 2021

Digital Health in the UK: MHRA Bold New (Regulatory) World?

In his statement to the House of Lords on September 16, Lord Frost announced that “we will use the provisions of the Medicines and Medical Devices Act 2021 to overhaul our clinical trial frameworks, based on outdated EU legislation, giving a major boost to the UK’s world-class R&D sector and … Read More

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27 January 2020

Highest European Court Confirms: No Presumption of Confidentiality Over Documents Submitted in Marketing Authorization Dossier

On January 22, 2020, the Court of Justice of the European Union (CJEU) found that there is not a general presumption of confidentiality over documents containing clinical and preclinical data provided to the European Medicines Agency (EMA) to support a marketing authorization application. However, the CJEU indicated that certain information … Read More

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01 November 2019

European Commission Provides Important Guidance on Qualification and Classification of Software Under New Medical Devices Regulations

The European Commission’s Medical Devices Coordination Group (MDCG) has published a much-anticipated guidance on the qualification and classification of software devices as medical devices (MDSW)1  under the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR) (the Guidance, available here). The Guidance seeks to provide clarification … Read More

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