Belgian medical and in-vitro diagnostic competent authorities merged in September 2017 for increased surveillance and traceability in devices on the EU market.
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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.
EU Vote on First Borderline Decision Confirms: Cranberry Products Are Not Medical Devices
EU vote confirms cranberry products are not medical devices. This is the first borderline product ruling adopted based on MDD 13(1)(d).
New limits for BPA in toys
New EU Commission Directive 2017/898 is set to enforce higher restrictions on Bisphenol A (BPA) in toys in the interest of consumer safety in Europe.
Additional requirements in the EMC Directive 2014/30/EU
Find out more about new manufacturer requirements and obligations under recent EU EMC directive 2014/30/EU. Talk to our regulatory experts about compliance.