Proposal for transitional provisions for certain in vitro diagnostic medical devices under Regulation (EU) 2017/746 European Commission issued a proposal (2021/0323 (COD)) for the amendment...
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MDR is in force since 26 May 2021. If you plan to CE Mark your medical device or prepare for MDR transition, of an existing device, 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…
The Number of Medical Device Notified Bodies is increasing
EU Commission has announced EU MDR 2017/745 designation of SGS Belgium as the 25th notified body (NB). With increasing number of NBs manufacturers may find...
Read MoreUse 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...
Read MoreFDA 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...
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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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Medical Device Software Life Cycle Management
The increased validation requirements of MDR (EU 2017/745) bring new...
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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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