Application Route for Performance Studies Under the In Vitro Diagnostics Regulations in Northern Ireland The MHRA has announced the approval of the first application for In Vitro diagnostic devices under the EU IVDR in Northern Ireland due to recent implementation of a submission route for manufacturers for performance studies. Application Route for Performance Studies Under the In Vitro Diagnostics Regulations in Northern Ireland
MHRA Strategy for Improving Safety Communications 2024 – 2027 MHRA has published their 3-year strategy for improving safety communications for 2024 to 2027. The strategy sets out MHRA’s ambition to transform the way they communicate about the risks and safety of medicines, medical devices and healthcare products in the UK to support effective implementation of new safety measures. MHRA Strategy for Improving Safety Communications 2024 – 2027
MHRA Data Strategy 2024 – 2027 Published MHRA has published its its data strategy 2024-2027. MHRA Data Strategy 2024 – 2027 Published
EMA Publishes Q&A on Labelling Requirements for Centrally Authorised Metered Dose Inhalers Containing Fluorinated Greenhouse Gases EMA has published its questions and answers on labelling requirements for centrally authorised metered dose inhalers containing fluorinated greenhouse gases document. EMA Publishes Q&A on Labelling Requirements for Centrally Authorised Metered Dose Inhalers Containing Fluorinated Greenhouse Gases
2024 Post-Market Surveillance Regulations for Medical Devices to be Presented in Parliament The MHRA announced on its LinkedIn channel its support for the government's plans to introduce the draft Post-Market Surveillance Regulations in Parliament later this year. 2024 Post-Market Surveillance Regulations for Medical Devices to be Presented in Parliament
Updated Schedule for 2024 MDCG and Subgroup Meetings Released The European Commission has published an updated version of planned meeting dates of the MDCG and subgroups for 2024. Updated Schedule for 2024 MDCG and Subgroup Meetings Released
Team NB – Updated Code of Conduct Team NB, the European Association of Notified Bodies, has updated its Code of Conduct. The previous version was published in 2019 and had only been updated to remove conflicts with the EU MDR and IVDR. Team NB – Updated Code of Conduct
PAGB Food Supplements Regulatory Workshop The upcoming PAGB Food Supplements Regulatory Workshop will take place in person on Thursday, 10 October, at PAGB's office from 10:00 AM to 4:00 PM. PAGB Food Supplements Regulatory Workshop
EU Medical Devices- Labelling of Fluorinated Greenhouse Gases Update The European Commission has published Regulation (EU) 2024/2174, outlining the rules for implementing Regulation (EU) 2024/573 concerning the labeling format for certain products and equipment containing fluorinated greenhouse gases. EU Medical Devices- Labelling of Fluorinated Greenhouse Gases Update
Public Consultation on EMA Draft Q&A: Co-Processed Excipients in Solid Oral Dosage Forms The European Medicines Agency (EMA) has published the draft questions and answers regarding co-processed excipients used in solid oral dosage forms for public consultation. Public Consultation on EMA Draft Q&A: Co-Processed Excipients in Solid Oral Dosage Forms
2024 DSIT Research and Innovation Workforce Survey The Department for Science, Innovation and Technology (DSIT) is conducting the 2024 Research and Innovation (R&I) Workforce Survey. The results will impact UK government policy and R&D funding decisions. 2024 DSIT Research and Innovation Workforce Survey
13th Notified Body Designated Under the EU MDR Italy-based notified body ‘ISTITUTO SUPERIORE DI SANITA' has been notified as the 13th Notified Body under the MDR. 13th Notified Body Designated Under the EU MDR