![EMA Guidance on Quality Documentation: Co-packaged Products](https://www.regdesk.co/wp-content/uploads/2021/08/EC-4-1-1024x675.jpg)
Aug 23, 2021
EU MDR/IVDR
The European Medicines Agency (EMA) has published guidelines dedicated to the quality documentation to be provided for medicinal products intended for use with medical devices. The present article addresses matters related to medicinal products with co-packaged or...
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![EMA Guidance on Medicines Used in Medical Devices](https://www.regdesk.co/wp-content/uploads/2021/08/EMA-Guidance-on-Medicines-Used-in-Medical-Devices-1-1080x675.png)
Aug 17, 2021
EU MDR/IVDR
The European Medicines Agency (EMA) has published guidelines on quality documentation for medicinal products when used with a medical device. The provisions of the guidance are based on the following regulations: Directive 2001/83/EC (the Medicinal Products Directive)...
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![EMA Guidance on Documentation for Medicines in Medical Devices](https://www.regdesk.co/wp-content/uploads/2021/08/EU-11.jpg)
Aug 12, 2021
EU MDR/IVDR
The European Medicines Agency (EMA) has published a guidance document dedicated to the quality documentation for medicinal products when used with a medical device. The present document constitutes a final version which will enter into force on January 1, 2022. Table...
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![MDCG on Medical Devices Containing Ancillary Substances](https://www.regdesk.co/wp-content/uploads/2019/12/4.jpg)
Jun 15, 2020
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body composed of representatives of all Member States who are focused on the improvement of the existing regulatory framework, recently issued guidance dedicated to medical devices containing ancillary...
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![Brexit Transition Period: EMA and MHRA Notice](https://www.regdesk.co/wp-content/uploads/2020/02/skynews-brexit-flags-westminster_4809232.jpg)
Feb 4, 2020
Europe
The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) issued detailed information on Brexit to assist medical device manufacturers in dealing with issues related to changes associated with the transition period. Due to...
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