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What is a PLIP and why is it required under MDR?
Article 10 (16) of the MDR obliges the manufacturer to have sufficient financial coverage for potential liability of defective medical devices. Read more!
What documents are required for EUDAMED Actor Registration?
Articles 31 of the MDR and Article 28 of the IVDR require all manufacturers, authorised representatives, and importers to register as actors on the EUDAMED database.
Reusable surgical instrument, a MDR legacy device?
The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).
How to obtain a safety assessment report and why is it important?
Considering the time spent on searching for an available safety assessor and several back-and-forth with…
How to enter the EU market – 7 tips for manufacturers of cosmetic products
The EU is an attractive market for cosmetic and personal care product brands; in 2022,…
3 Tips to Obtain IVDR Certification
The EU In-Vitro Diagnostic Regulation (IVDR) has applied since May 26, 2022, significantly changing regulatory…
How to get the CPNP numbers to sell your cosmetics in the EU?
Manufacturers of cosmetics often work with very tight deadlines and the waiting time for regulatory…
What are the documents needed to comply with IVDR and UK IVD?
Regardless of type of IVD, there are certain common requirements to place your device on…
The 3 laboratory tests you need to sell your cosmetics in the EU and UK
The EU and UK Regulations on cosmetic products aim at ensuring the safety of cosmetic…