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

  A device shall meet the general safety and performance requirements(GSPR) to comply MDR 2017/745.

MDD Essential requirements(ER) are replaced by GSPRs.

MDR Annex I-GSPR have below listed categories 

• Chapter I:GENERAL REQUIREMENTS(1-9)
• Chapter II:REQUIREMENTS REGARDING DESIGN AND MANUFACTURE(10-22)
• Chapter III:REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE(23)

S.No	Requirements	MDD/ AIMDD Corresponding ERs
Chapter I General Requirements
GSPR 1	Performance and safety	MDD and AIMDD ER 1
GSPR 2	Reduction of risks	MDD ER 2 and AIMDD ER 8.
GSPR 3	Risk management system	NEW
GSPR 4	Risk control measures and residual risks	ER 2 MDD and ER 6 AIMDD
GSPR 5	Risks related to use	MDD ER 1 and no AIMDD ER
GSPR 6	Device lifetime	ER 4 MDD and ER 3 AIMDD
GSPR 7	Packaging, transport, storage	ER 5 MDD and ER 4 AIMDD
GSPR 8	Risk-benefit ratio	MDD ER 6 and AIMDD ER 5
GSPR 9	Devices without a medical purpose	NEW
Chapter II-Requirements regarding design and manufacture
GSPR 10	Chemical, physical and biological properties	MDD ER 7 and AIMDD ER 9
GSPR 10.1	General considerations for materials	ER 7.1 MDD and ER 9 AIMDD
GSPR 10.2	Risks from contaminants and residues	ER 7.2 MDD and no AIMDD ER
GSPR 10.3	Compatibility with materials and substances	ER 7.3 MDD and no AIMDD ER
GSPR 10.4	Substances	NEW
GSPR 10.4.1	Design and manufacture of devices	NEW
GSPR 10.4.2	Justification regarding the presence of CMR and/or endocrine-disrupting substances	NEW
GSPR 10.4.3	Guidelines on phthalates	NEW
GSPR 10.4.4	Guidelines on other CMR and endocrine-disrupting substances	NEW
GSPR 10.4.5	Labelling	NEW
GSPR 10.5	Risk of unintentional ingress	ER 7.6 MDD and AIMDD ER 9
GSPR 10.6	Risks related to particle size	NEW
GSPR 10.7	Infection and microbial contamination	MDD ER 8 and AIMDD ER 7
GSPR 11.0	Infection and microbial contamination	MDD ER 8 and AIMDD ER 7
GSPR 11.1	Risk of infection	MDD ER 8.1 and no AIMDD ER
GSPR 11.2	Design for reuse	NEW
GSPR 11.3	Devices with a specific microbial state	NEW
GSPR 11.4	Devices delivered sterile	MDD ER 8.3 and AIMDD ER 7
GSPR 11.5	Validation for sterile devices	MDD ER 8.4 and no AIMDD ER
GSPR 11.6	Environmental controls	MDD ER 8.5 and no AIMDD ER
GSPR 11.7	Packaging for non-sterile devices	MDD ER 8.6 and no AIMDD ER
GSPR 11.8	Labelling for sterile state	MDD ER 8.7 and no AIMDD ER
GSPR 12	Devices incorporating a medicinal product; substances absorbed or locally dispersed	MDD ER 7.4 and no AIMDD ER
GSPR 12.1	Devices incorporating a medicinal product	MDD ER 7.4 and no AIMDD ER
GSPR 12.2	Devices composed of substances absorbed or locally dispersed	NEW
GSPR 13	Devices incorporating materials of biological origin	MDD ERs 7.4 and 8.2; and no AIMDD ER
GSPR 13.1	Tissues, cells or derivatives of human origin	MDD ER 7.4 and AIMDD ER 10 Scope extended
GSPR 13.2	Tissues, cells or derivatives of animal origin	MDD ER 8.2 and no AIMDD ER
GSPR 13.3	Other non-viable biological substances	NEW
GSPR 14	Construction of devices and interaction with their environment	MDD ER 9 , ER 10.2 and AIMDD ER 9.1
GSPR 14.1	Use in combination	MDD ER 9.1 and AIMDD ER 9.1
GSPR 14.2	Risks of interaction with the environment	14.2(a, b, f and g) -MDD ER 9.2. 14.2(c) -MDD ER 7.3. 14.2(e)- ER 7.6. 14.2 (d) -NEW Covered in AIMDD ER 8
GSPR 14.3	Risks of fire or explosion	MDD ER 9.3 and no AIMDD ER
GSPR 14.4	Design for adjustment, calibration and maintenance	NEW
GSPR 14.5	Design for compatibility	MDD ER 9.1 and AIMDD ER 9.1
GSPR 14.6	Measurement, monitoring or display scales	MDD ER 10.2 and no AIMDD ER
GSPR 14.7	Design and manufacture for safe disposal	NEW
GSPR 15	Devices with a diagnostic or measuring function	MDD ER 10.1 and 10.3 and no AIMDD ER
GSPR 16	Protection against radiation	MDD ER 11 and AIMDD ER 8
GSPR 17	Electronic programmable systems – devices that incorporate electronic programmable systems and software that are devices in themselves	17.1-MDD ER 12.1. and no AIMDD ER 17.2-MDD ER 12.1(a). and  AIMDD ER 9 17.3 & 17.4 - NEW
GSPR 18	Active devices and devices connected to them	18.1-MDD ER 12.1 18.2-MDD ER 12.2 18.3-MDD ER 12.3 18.4-MDD ER 12.4 18.5-MDD ER 12.5 18.6-NEW 18.7-MDD ER 12.6 18.7-NEW
GSPR 19	Particular requirements for active implantable devices	Covered in AIMDD
GSPR 19.1	Particular risks to be reduced for active implantable devices	AIMDD ER 8
GSPR 19.2	Device compatibility and reliability of energy	AIMDD ER 9
GSPR 19.3	Identification of devices and components	AIMDD ER 11
GSPR 19.4	Identification code	AIMDD ER 12
GSPR 20	Protection against mechanical and thermal risks	MDD ER 12.7 and no AIMDD ER
GSPR 21	Protection against the risks posed to the patient or user by devices supplying energy or substances	MDD ERs 12.8.1, 12.8.2 and 12.9 and AIMDD ER 9
GSPR 22	Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons	NEW

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Source: REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC