2017/745

Use of Harmonised Standards: MDCG 2021-5

Use of Harmonised Standards The MDCG 2021-5 Guidance on standardisation for medical devices explains the use of harmonised standards for demonstrating compliance to MDR (EU 2017/745 ) and IVDR (EU 2017/746) . Although this guidance document does not include new information, it is especially helpful for medical device start-ups and manufacturers, which are at the …

FDA Biocompatibility Assessment Resource Center

FDA issued a new page called “Biocompatibility Assessment Resource Center”, where you can find useful information for your biocompatibility evaluation. The web pages mainly include explanation of terms and concepts important for a biocompatibility evaluation of a medical devices.  As you might already know, the general principals are already specified in the guidance document “Use …