Swissdamed: Database for Medical Devices in Switzerland
In Switzerland, Swissmedic enforces the registration of economic operators and medical devices. For this purpose, Swissmedic implemented a new database: Swissdamed.
In the last years, the EU has significantly revised the legislation covering medical devices to be aligned with the most recent developments in technology and healthcare.
The Commission has issued a draft decision for the request to prepare new and updated standards for childcare articles other than toys
The EU vision on plastic waste: is a safe and sustainable plastics industry possible?
Among many steps, the Opinion published in August 2022 stresses out that establishing a clear and common regulatory framework is essential. Internally, each EU market must ensure an equal application of the regulatory requirements of sustainability.
Omnibus Act V is officially published
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On September 5, 2022, the Office for Product Safety and Standards (OPSS) published a new update on the transitional labelling requirements of cosmetic products.
Safety of children’s products (excluding toys) – Draft Commission Decision
What are the effects of the implementation of MDR on the EU medical device market?
OPSS extends transitional labelling provisions for cosmetics to 2025
COSMETICS NEWSFEED »
Webinar: IVDR VS IVDO
In this webinar, we are giving an overview of the IVD regulatory framework for Switzerland and Europe and answering your top questions:
- What shall a non-Swiss company do to sell its devices in Switzerland?
- What are the requirements for a Swiss company trading in the EU?
As expected, on September 16, 2022, the European Commission published Commission Regulation (EU) 2022/1531, namely the Omnibus Act V.
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Key Fact Series
EU regulations can be complicated to understand, but we like making it easy for you! Here are the key facts for MDR, IVDR & Cosmetic products you should keep in mind. Watch the videos:
34 years ago, Mr. Gideon Elkayam turned his vision into reality and founded Obelis Group. It has been a long road, but despite all the challenges, we are stronger today than ever.
Thank you for choosing Obelis to meet the compliance requirements in Europe. Happy Birthday to all of us, our team members and our clients, who are contributing to the company’s accomplishments!