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EU MDR Navigation Panel EU IVDR Navigation Panel Clinical Evaluation [EU] Authorised representative Orthopedics Software Implementation Model EU(EC) TOPRA
Clinical Evaluation Combination Products Quality Management System (QMS) IVD Assay In Vitro Diagnostic Device (IVD) IVD Device for near-patient testing

MDCG 2018-8: Guidance on content of the certificates, voluntary certificate transfers	Consultation: Regulation of software, including Software as a Medical Device (SaMD)	Updated: Notify MHRA about a clinical investigation for a medical device	Draft: Principles of Premarket Pathways for Combination Products	SwissMedic: Modified ordering requirements for export certificates (FSC)	Consultation on Draft Guidance for Software as a Medical Device (SaMD)
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EU MDR 2017/745 + Implementing Acts	EU IVDR 2017/746 + Implementing Acts	CFR Title 21 Subchapters A & H	FDA Medical Devices Guidance Documents	All Regulations China (English Translation)	All Regulations Brazil (English Translation)
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EU MDR / IVDR Documentation Status	January 2019 News Review Report	EU MDR 2017/745	EU IVDR 2017/746	EU Directive 93/42 ECC vs EU MDR 2017/745 comparison	EU Directive 98/79 EC vs EU IVDR 2017/746 comparison
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