News Archive

EMA - One Health: How EU agencies are tackling environmental and public health together

23rd May 2024

On 22nd May 2024, the European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), and the European Medicines Agency (EMA) published a joint framework for action to strengthen cooperation to support the implementation of the One Health agenda in the European Union (EU).

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HMA - Recommendation Paper on Principles of GLP

23rd May 2024

New recommendation paper on principles of Good Laboratory Practices (GLP) for clinical trial applications under the EU Clinical Trials Regulation (Regulation (EU) No 536/2014)

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MHRA - MHRA announces consultation on improved safety for high risk in vitro diagnostic devices

23rd May 2024

Launch of a a four-week consultation which will support improved safety for certain high risk in vitro diagnostic (IVD) devices. IVD devices are used to examine samples taken from the human body and to diagnose and monitor health conditions. For example, devices can determine blood glucose levels and can identify infectious diseases. Accurate performance and trust in the quality of these products are crucial to healthcare professionals considering their use in treating patients.  The new policy we are consulting on would require manufacturers to comply with additional measures for certain high risk IVDs, such as blood tests used to identify blood type before transfusions or tests which identify life-threatening diseases, introducing harmonised requirements for these products. We are also seeking views on the removal of the Coronavirus Test Device Approval (CTDA) process to avoid duplication of regulatory requirements for COVID-19 tests against the Common Specification requirements.   The MHRA intends to incorporate updates to IVD common specifications within a draft Statutory Instrument as part of the future core medical device regulations to be published later in 2024. The updated regulations will then come into force in 2025.     Dr Laura Squire, MedTech Regulatory Reform Lead and Chief Healthcare Quality and Access Officer, MHRA said: We look forward to feedback on our consultation on common specification of IVDs, as we look to strengthen safety requirements around certain classes of crucial diagnostic devices.

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MHRA - proposed framework for international recognition of medical devices

23rd May 2024

MHRA announces a proposed framework for international recognition of medical devices

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MHRA - launches AI Airlock to address challenges for regulating medical devices that use Artificial Intelligence

9th May 2024

New regulatory sandbox for AI as a Medical Device (AIaMD).

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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)

8th May 2024

22-25 April 2024

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EMA - One Health: a joint framework for action published by five EU agencies

8th May 2024

The European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), and the European Medicines Agency (EMA) published a joint framework for action to strengthen cooperation to support the implementation of the One Health agenda in the European Union (EU).

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FDA - Roundup

8th May 2024

7th May 2024

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MHRA - April MedTech regulatory reform update: international recognition, IVDs and AI

8th May 2024

Laura Squire, 25 April 2024

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MHRA - Update on pioneering initiative on regulation and evaluation of digital mental health technologies

8th May 2024

An MHRA and NICE partnership, funded by Wellcome, is addressing key challenges for regulating and evaluating digital mental health technologies (DMHTs) with input from patients, the public and mental health professionals.

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