IVDR General Safety and Performance Requirements(Chapter I & II)

 A device shall meet the general safety and performance requirements(GSPR) to comply MDR 2017/746.

MDD Essential requirements(ER) are replaced by GSPRs.

MDR Annex I-GSPR have below listed categories 

Chapter I:GENERAL REQUIREMENTS(1-8)

Chapter II:REQUIREMENTS REGARDING DESIGN AND MANUFACTURE(9-19)

Chapter III:REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE(20)

S.No	Requirements	IVDD Corresponding ERs
Chapter I General Requirements
GSPR 1	Performance and safety	A.1
GSPR 2	Reduction of risks	NEW
GSPR 3	Risk management system	NEW
GSPR 4	Risk control measures and residual risks 4(c)-NEW	A.2
GSPR 5	Risks related to use	NEW
GSPR 6	Device lifetime	A.4
GSPR 7	Packaging, transport, storage	A.5
GSPR 8	Risk-benefit ratio	NEW
Chapter II-Requirements regarding design and manufacture
GSPR  9	Performance characteristics 9.2 & 9.3- NEW	A.3
GSPR 10	Chemical, physical and biological properties 10.3 & 10.4-NEW	B.1.1,B.1.2
GSPR 11.0	Infection and microbial contamination 11.6-NEW	B.2.1,B.2.3, B.2.4, B.2.6, B.2.7
GSPR 12	Devices incorporating materials of biological origin	B.2.2
GSPR 13	Construction of devices and interaction with their Environment 13.2(d), 13.2(e), 13.2(f), 13.2(g),13.4,13.5-NEW	B.3.1,B.3.2,B.3.3,B3.4,B.3.5,B.3.6
GSPR 14	Devices with a measuring function	B.4.1, B.4.2
GSPR 15	Protection against radiation	B.5.1, B.5.2, B.5.3
GSPR 16	Electronic programmable systems – devices that incorporate electronic programmable systems and software that are devices in themselves 16.2,16.3,16.4-NEW	B.6.1
GSPR 17	Devices connected to or equipped with an energy source 17.1,17.2,17.4-NEW	B.6.2, B.6.3
GSPR 18	Protection against mechanical and thermal risks 18.7-NEW	B.6.4
GSPR 19	Protection against the risks posed by devices intended for self-testing or near patient testing 19.3(b)-NEW	B.7

Click below link to know more about MDR General Safety and Performance Requirements(Chapter I & II) :https://meddev-info.blogspot.com/2021/01/mdr-general-safety-and-performance.html

Source:

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU 

NSF International.Whitepaper on EXPLORING THE RELATIONSHIPBETWEEN THE IVDR AND THE IVDDGeneral Safety and Performance RequirementsVersus Essential Requirements.