The first module of the EUDAMED (European Databank on Medical Devices ) is live as of 1st December of 2020. This will enable economic operators...
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The new date of application of MDR is 26 May 2021. If you plan to CE Mark your medical device or prepare for MDR transition, this “How to?” article maybe useful for you…
Premarket notification process, known as a 510 K submission, is required for Class II devices to enter the US Medical Device Market…
This 2016 revision of the standard provides a basis for the quality management system in parallel to the EU MDR and other international regulatory changes…
The implementation of the ISO 14971 standard by the manufacturer is the most appropriate solution to ensure the requirements for risk management…
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...
Read MoreMDCG 2020-16 Guidance on Classification Rules for IVDR
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...
Read MoreThe Number of Medical Device Notified Bodies is increasing
On 16th of September EU Commission has announced EU MDR 2017/745 designation of 3EC International a.s. located in Slovakia as the 17th notified body (NB)....
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EU Medical Device Regulation – How to CE Mark a Medical Device ?
CE mark is required for each medical device sold in...
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US FDA 510 K Submission – How to prepare a 510 K File?
Food and Drug Administration (FDA) is the legal authority to...
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MDR Clinical Evaluation Requirements
MDR Clinical Evaluation Requirements including clinical investigation are defined on...
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PMCF, PMS and PSUR Requirements
PMCF (Post Market Clinical Follow-Up) is maybe one of the...
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