To market medical devices in the EU, manufacturers must provide clinical data specific to the European population.
New Toy Safety Regulation and the Digital Product Passport: upcoming changes for the toy industry
The update aims to address shortcomings in protecting children from toy-related risks, notably concerning hazardous chemicals.
The RP Mandate: an essential document for cosmetic compliance
The EU Cosmetics Regulation establishes that only products for which a legal or natural person is designated within the European Union as Responsible Person (RP) can be placed on the market.
European Parliament votes in favour of new IVDR legacy period and EUDAMED roll-out plan
Stay informed on upcoming cosmetic regulatory changes. Learn about the deadlines and new requirements for compliance in 2024.
Selling Medical Devices in Europe as a Chinese manufacturer?
Stay informed on upcoming cosmetic regulatory changes. Learn about the deadlines and new requirements for compliance in 2024.
Meet Obelis at Cosmoprof Bologna 2024 for Expert Guidance on EU, UK & US Cosmetic Regulations
Find us at Hall 16, Booth H/32 I/31 to explore Regulatory Strategies for Cosmetics in Global Markets.
How to prepare for the proposed extension for IVD medical devices
The EU’s proposed extension for IVD medical devices aims to prevent shortages. Manufacturers must prepare by meeting IVDR requirements promptly.
Webinar: MoCRA deadline has passed-what it means for your cosmetic business to sell in the USA
Join our new live webinar February 15th: MoCRA deadline has passed-what it means for your cosmetic business to sell in the USA
Obelis Group at Arab Health 2024 – Here is a successful story in medical device regulations
Obelis Group at Arab Health 2024 – Here is a successful story in medical device regulations