Post-market surveillance requirements are strengthened under new EU medical device regulation 2017/745. Find out what implications it has for your device.
Medical devices and healthcare auto
New WEEE Directive 2012/19/EU (Waste of Electric & Electronic Equipments) is published
Learn more about the objectives and main amendments of new EU Waste if Electric & Electronic Equipments regulation 2012/19/EU.
Sanitary Certificates in Italy
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.
Merger of Belgian IVD & MD authorities
Belgian medical and in-vitro diagnostic competent authorities merged in September 2017 for increased surveillance and traceability in devices on the EU market.
Medical apps under the new European MDR
Exploring the differences and between medical and well-being apps under the scope of EU medical device regulation 2017/745 and their legal requirements.
The importance of GMDN Codes
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.
New EU Borderline and Classification Manual on Medical Devices
A manual has been published on borderline products and classification under EU medical device regulation 2017/745. It contains guidance on harmonised standards.
New European Notified Body Product Codes Open for Consultation
Public consultation has been opened on the implementation of the new notified body product codes under the oncoming EU medical device and IVD regulations.
Revised guideline on first- in-human clinical trial
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.
Upcoming changes in Medical Devices Regulation in Australia
A number of changes have been made to Australian medicines and medical devices regulations to improve consumer access and remove red tape for manufacturers.