medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms is currently in progress. This project should have a wide ranging and positive impact on industry stakeholders and regulatory agencies in the EU. At its core appears…
The European Commission is conducting a targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities. About Commission Implementing Regulations A Commission Implementing Regulation is a legally binding act of the European Union. It is…
The Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council has been published. About commission Implementing…
The Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Medical Devices Regulation (EU) 2017/745 (MDR) of the European Parliament and of the Council has been published. About commission Implementing…
The European Commission (EC) has launched an online stakeholder consultation on the definition of nanomaterial. This consultation follows a review of its Recommendation 2011/696/EU on the definition of nanomaterial. The online targeted stakeholder consultation is to update, test and verify the preliminary…
The European Medicines Agency (EMA) is consulting the public on draft common EU standards for electronic Product Information (ePI). You can read more about ePI here. About the draft common standard for ePI The draft EU common standard for ePI…
The European Commission (EC) is seeking feedback on a draft implementing regulation on setting up and maintaining the European Database on Medical Devices (EUDAMED). About EUDAMED EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on…
The European Commission has written to the Medical Devices Coordination Group (MDCG) updating it on the EU-Turkey Customs Union for medical devices. According to the letter, the final steps to update the EU-Turkey Customs Union for medical devices have been…
The European Commission (EC) has launched a public consultation on the revision of the legislation on medicines for children and rare diseases. What does the consultation hope to achieve? The consultation is an important step in the process of assessing…
The European Commission has published a strategy to support the development and availability of much-needed COVID-19 therapeutics, including for the treatment of ‘long COVID’. The strategy covers the full lifecycle of medicines: from research, development and manufacturing to procurement and…