Common specifications for the groups of products without an intended medical purpose listed in Annex XVI of EU 2017/745 MDR
After the issue of implementing regulation for the reprocessing of single-use devices, EU Commission issued the implementing regulation 2022/2346 as regards common specifications (CS) for the groups of products without an intended medical purpose listed in Annex XVI of EU 2017/745 MDR. The manufacturers who aim to produce the products covered by Annex XVI… Read more
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… Read more
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… Read more
EUDAMED Single Registration Number
The first module of the EUDAMED (European Databank on Medical Devices ) is live as of 1st December of 2020. This will enable economic operators to get a Single Registration Number (SRN). MDR Registration Requirements As you know, Chapter III of the MDR EU 2017/45 deals with identification and traceability of medical devices including registration… Read more
EMC of Medical Devices – Draft FDA Guidance
EMC of Medical Devices – 510 K Content For active medical devices, the EMC information is an important part of the 510 K file. Currently the required information is listed on the guidance document “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices” issued on July 2016. FDA issued recently a… Read more