EMA Q&A on implementation of the Medical Devices Regulations

31. Oktober 2019 – EMA's Human Medicines Evaluation Division has released a document on questions & answers on implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 - MDR and (EU) 2017/746 - IVDR). The stated Regulations replace the three existing Directives (93/42/EEC, 98/79/EC and 90/385/EEC) for medical devices. The Regulations entered into force on 25 May 2017. However, they will have a transition period to allow manufacturers, notified bodies and authorities to comply with the changes and will come into full application on 26 May 2020 (MDR) and 26 May 2022 (IVDR). These regulations lay down roles and responsibilities for EMA and National Competent Authorities for medicinal products. For further information, see here.