Although the date of application of the Medical Devices Regulation (MDR) has been postponed, on 26 May 2021 the Regulation will become fully applicable, following the transition period. As previous...
Read moreDominique Monferrer, Asphalion’s Medical Devices Expert, was invited to give a talk on Regulatory Aspects for Medical Devices to participants of the 3rd edition of Craash Barcelona program organized...
Read moreRainer Rothe, Scientific and Regulatory Affairs Officer at Asphalion, attended the online session “Improving Human Health Through Artificial Intelligence” organised by CataloniaBio & HealthTech in...
Read moreDespués de varios desencuentros… e.g. publicación de EN ISO 14971:2019 y EN ISO 24971:2020 sin anexos Z, el comité CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical d...
Read moreThe European Commission (EC) has published a Commission Implementing Regulation to ease the renewal of the designation of notified bodies (NBs) and prevent shortages of medical devices (MDs) in the Eu...
Read moreOur last webinar is available on Asphalion’s YouTube Channel.
Read moreThis week brings some good news for the medical devices (MD) manufacturers and notified bodies, as 4 different guidance documents on topics related to clinical investigation and evaluation have bee...
Read moreAsphalion and its experts are committed to bring solutions and alternatives to society during this exceptional situation. That is why we are offering all our expertise in Regulatory Affairs by:
Read moreThe Council of the European Union has published a second set of corrections as part of a corrigendum for the EU’s Medical Devices Regulation (MDR) giving manufacturers of Class I devices upclassi...
Read moreThe European Medicines Agency (EMA) has recently revised the Question and Answer (Q&A) document that provides practical considerations concerning the implementation of the medical devices (MDR) and th...
Read moreOn 6th June 2019 COCIR (European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry), the European trade association representing the medical imaging, radiotherapy, ...
Read moreThe European Medicines Agency (EMA) released a draft guideline on the quality requirements for medical devices (MD) in human medicines that include a MD (known as drug device combinations or DDC) f...
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