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

Single Use Medical Device Reprocessing

Single use medical device reprocessing has always been a challenge for many health institutions. The new medical device regulation (MDR) EU 2017/745 defines requirements for “single-use devices and their reprocessing” in Article 17. On 19th of August 2020, EU commission issued the implementing regulation 2020/1207 as regards common specifications (CS) for the reprocessing of single-use … Read more

UDI – Unique Device Identification System

The EU Commission issued Q&A document for Unique Device Identification (UDI) System. This guidance document gives an overview of the new UDI system and obligations of operators, which have to be fulfilled to CE Mark a medical device. For other details you can check our article “How to CE Mark a Medical Device” The UDI … Read more

Surgical Mask – FDA Issues Umbrella EUA

On August 5, 2020, the FDA issued an umbrella emergency use authorization (EUA) for certain disposable, single-use surgical masks in response to concerns relating to insufficient supply and availability of such masks. This EUA authorizes the emergency use of surgical masks that meet certain performance requirements for use in healthcare settings by health care personnel … Read more

Clinical Evaluation Report Template

The MDCG issued MDCG 2020 -13 guidance for notified bodies (NB) specifying a template to be used during auditing the clinical evaluation (CER) of manufacturers. Although the guidance document is intended for the NB’s, manufacturers can benefit from it during preparation of the clinical evaluation report template. CER is a core requirement of the Medical … Read more