A manual has been published on borderline products and classification under EU medical device regulation 2017/745. It contains guidance on harmonised standards.
News
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.
Switzerland harmonizes Cosmetics Regulation with EU’s
Under Project LARGO, Switzerland has overhauled its food and consumer product regulations, harmonizing them with current EU laws and standards.
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.
Do cosmetics sales on the Internet need to follow EU rules?
Do cosmetics products sold online need to comply with EU regulations? Of course! Products sold online within the EU are fully covered by all EU regulations.
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
Newly defined devices under the IVDR
New EU regulation shifts in-vitro device classification from list-based to risk-based, allowing for greater innovation and scope for manufacturers in Europe.
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).
Should I work with my importer to register my cosmetic products?
EU regulations require a European Responsible Person be designated for products to be registered and placed on the EU market by any non-EU manufacturer.