MedloftAdmin 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 …
The ISO 14971 Risk Management standard defines principles for a risk management process of medical devices. The requirements given in this standard help manufacturers to comply with the main regulations. So, by implementing an ISO 14971 Risk Management Process you can have a big step in your EU MDR, IVDR or FDA certification route. The …
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 …
The Medical Device Single Audit Program (MDSAP) is led by Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer’s quality management system that will satisfy the requirements of the medical device regulatory authorities participating in …
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 …
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 …
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 …
The EU Commission has issued guidance documents for Medical Device Software within the scope the EU 2017/745 MDR and EU 2017/746 IVDR. The first publishment related with MDSW is MDCG 2019-11, contains information on the qualification and classification of medical device software. The second one is MDCG 2019-16 which is a guidance document on Cybersecurity for …
MDR Transitional Period The guidance document for the implementation of Article 120, which many companies plan to use during the transition to MDR EU 2017/745, has been published. The main requirements for the validity of the 93/42/EEC and 90/385/EEC certificates after May 2021 can be summarised as; The guidance includes a paragraph about the surveillance …