Medloft News​

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 […]

Last week EU Commission has announced EU MDR 2017/745 designation of Eurofins Expert Services Oy located in Finland as the 20th notified body (NB). But considering the current  the performance of these for accepting applications,  question “Have we enough Medical Device Notified Bodies for EU Market?” remains open. Since beginning of 2019, when the first NB […]

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 […]

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 […]

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 […]

MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 Article 47 of the IVDR EU 2017/746 defines four new risk classes (A, B, C, D) considering the intended purpose of the devices. As an IVD manufacturer you should review the 7 classification rules given on Annex VIII of […]

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 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 a new guidance document for use with the EU 2017/745 MDR and EU 2017/746 IVDR.This document, MDCG 2019-11, contains information on the qualification and classification of  medical device software. You can reach MDCG 2019-11 from this link. Share on linkedin LinkedIn Share on email Email Recent News How can we […]

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; No significant changes on the device design Implementation […]