In order to protect public health, shipments of goods of medical interest imported from third countries and arriving at the international entry points of the Italian territory are subject to controls by the National Medical Authority.
Read more on this topic here.
Belgian medical and in-vitro diagnostic competent authorities merged in September 2017 for increased surveillance and traceability in devices on the EU market.
Exploring the differences and between medical and well-being apps under the scope of EU medical device regulation 2017/745 and their legal requirements.
According to the European Commission decision from 19th April 2010, uploading data into EUDAMED requires the use of GMDN codes. Read more on this topic.
A manual has been published on borderline products and classification under EU medical device regulation 2017/745. It contains guidance on harmonised standards.
Public consultation has been opened on the implementation of the new notified body product codes under the oncoming EU medical device and IVD regulations.
From February 2018, new guidelines will enter into force on in-human clinical trials. Talk to Obelis about the implications this may have for your products.
A number of changes have been made to Australian medicines and medical devices regulations to improve consumer access and remove red tape for manufacturers.
Electronic cigarettes work by heating up a liquid until vaporization is reached. This is essentially another way of putting nicotine into your body. How are electronic cigarettes being regulated under the EU Law ? Are these to be considered as tobacco products or something else ? Read more on this topic
New EU regulation shifts in-vitro device classification from list-based to risk-based, allowing for greater innovation and scope for manufacturers in Europe.