Learn all you need to know about EU PPE Regulation 2016/425 before it enters full effect on April 21st 2018. Talk to Obelis' experts about your compliance.
Other Industries
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.
Selling Cosmetics in Portugal
Non-EU Manufacturers and their EU importers have to meet specific requirements to sell Cosmetic Products in Portugal in the context of Market Surveillance activities at Customs. Read more about which requirements are necessary.
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 new CE marking process for the Low Voltage Equipment
The new European Low Voltage Directive (LVD 2014/35/EU) outlines a new CE marking process for equipment on or to be introduced to the EU market.
(P) Steps to obtain CE Marking for your PPE 89/686/EEC Directive Products
Develop a roadmap towards obtaining a CE mark and compliance program for your PPE with Obelis' European Authorized Representative services.
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.
Are E-Cigarettes regulated as Medical Devices ?
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
What is the CE Marking Process?
The Obelis' team break down and explain the European CE marking process and the steps required in obtaining a CE mark for a product or device on the EU market.