Under the Medical Device Regulation, the General Safety and Performance Requirements (GSPRs) of Annex I are more demanding that their Medical Device Directive counterparts, the Essential Requirements. Where the Directive included 13 Essential Requirements, the Regulation has 23 requirements that must be considered.

Medical device manufacturers must demonstrate conformity with the GSPRs, including the use of justification, validation, and verification of the solutions used to meet the applicable requirements. For those requirements which are considered to not be applicable, a justification of this fact must be provided.

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What does a completed MDR GSPR Checklist include? 

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• The general safety and performance requirements that apply to the device and an explanation as to why others to not apply;

• The method or methods use to demonstrate conformity with each applicable requirement;

• The standards, common specifications, or other solutions applied to meet the requirement;

• The precise identity of the controlled documents offering evidence of conformity with each standard, common specification or other method applied to demonstrate conformity with the general safety and performance requirements.

• The information referred to under this point shall incorporate a cross-reference to the location of such evidence with the full technical documentation.

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What are the MDR GSPR Requirements? 

 

- Chapter I (GSPRs 1 – 9) examines the General Requirements related to risk management, risk control, and benefit-risk. The first eight GSPRs in this chapter apply to all devices.
- Chapter II (GSPRs 10 – 22) deals with Requirements Regarding Design, and Manufacture. This chapter is broken down into the following subsections:
o Chemical, physical and biological properties
o Infection and microbial contamination
o Devices incorporating a substance considered to be a medical product
o Devices incorporating materials of biological origin
o Construction of devices and interaction with their environment
o Devices with a diagnostic or measuring function
o Protection against radiation
o Electronic programmable systems
o Active devices and devices connected to them
o Particular requirements for active implantable devices
o Protection against mechanical and thermal risks
o Protection against the risks posed to the patient or user by devices supplying energy or substances
o Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons

- Chapter III (GSPR 23) focuses on Requirements Regarding Information Supplied With The Device, specially the following aspects:
o Label and instructions for use
o General requirements regarding the information supplied by the manufacturer
o Information on the label
o Information on the packaging which maintains the sterile condition of a device
o Information in the instructions for use.

The applicability of the requirements listed in Chapters II and III should be examined on a case-by-case basis, depending on the nature of the device in question.

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How to use this GSPR Checklist 

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• Download this easy-to-use GSPR template as a Microsoft Word document straight to your PC

• Sample text has been included in blue italics throughout the checklist to aid as guidance for your own data 

• Easily identify the standards or other solutions that are relevant to your device, and to each GSPR

• Helpful suggestions are included on the available methods that could be used to demonstrate conformity to each GSPR

• It's fully free - no catch! 

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