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IVDR 2017/746 IVDR GSPR

General Safety and Performance Requirements

General Safety and Performance Requirements (GSPR)

General Safety and Performance Requirements (GSPR) are almost similar to Essential Requirements (MDD), there are some additional requirements and some expanded requirements, and some new topics are introduced in GSPR. For example, Risk-benefit ratio, medical devices incorporating materials of biological origin, devices without a medical purpose, laypersons use additional requirements in labels, etc.

 

The essential requirements (ER) are the key elements to compliance with MDD and AIMDD. The new regulation EU MDR replaces the essential requirements (ER) by GSPR. This means the manufacturers must demonstrate conformity with the general safety and performance requirements and other legal requirements, such as those relating to quality and risk management, laid down in this regulation

GSPR Sections

The new EU MDR and EU IVDR, which repealed the Medical Devices Directive 93/42/EEC, Active Implantable Medical Devices Directive 90/385/EEC, and In Vitro Diagnostic Medical Devices Directive 98/79/EC, were released on April 5, 2017. In Annex I of the new rules, there are 23 GSPR standards for medical devices, compared to 13 essential requirements in MDD, and 20 GSPR requirements for in vitro diagnostic devices, compared to 13 key requirements in IVDD.

 

To guarantee device safety and performance, the manufacturer must show compliance with these GSPR standards as well as other regulatory criteria for quality and risk management.

The requirements of MDR GSPR are covered in Annex I in 3 chapters

 

  • Chapter 1 – General Requirements
  • Chapter II – Requirements regarding design and manufacture
  • Chapter III – Requirements regarding the information supplied with the device

Chapter I - General Requirments.

Clause Number 1 to 9 of MDR and Clause Number 1 to 6 in MDD explain the general requirement.

 

⇒ Performance and Safety

⇒ Reduction of risk

⇒ Risk Management System

⇒ Risk control measures and residual risks

⇒ Risks related to the use of error

⇒ Performance and lifetime of the medical devices

⇒ The characteristics and performance are not adversely affected during transport and storage

⇒ All foreseeable risks shall be acceptable when weighed against the benefits to the patient /user

⇒ Devices without a medical purpose

 

In this chapter, additional clauses are added related to risk management compared to IVDD, such as the risk control measures during the design and manufacturing stages, risk mitigation measures for the foreseeable risks or any other undesirable effects.

Chapter II - Requirements regarding Design and Manufacture

Clause numbers 10 to 22 of MDR and Clause Number 7 to 12 in MDD explain the requirements regarding design and manufacture.

 

⇒ Chemical, physical and biological properties,

⇒ Risks from Contaminants & Residues

⇒ Compatibility with Materials & Substances

⇒ Substances contained in & Released from the Device

⇒ Infection & Microbial Contamination

⇒ Devices incorporating a medicinal product or substances absorbed by the human body,

⇒ Devices incorporating materials of biological origin,

⇒ Construction of devices and interaction with their environment,

⇒ Devices with a diagnostic or measuring function,

⇒ Protection against radiation,

⇒ Electronic programmable systems and software,

⇒ Active devices and devices connected to them,

⇒ Particular requirements for active implantable devices,

⇒ Protection against mechanical and thermal risks,

⇒ Protection against the risks posed to the patient/user by devices supplying energy 

⇒ Protection against the risks posed by medical devices intended for use by laypersons

 

In Chapter II of MDR, some of the additional requirements are Chemical, physical and biological properties, Justification regarding the presence of CMR and/or endocrine-disrupting substances, Infection & Microbial Contamination, Devices incorporating medicinal products or substances absorbed by the human body and Risks of Interaction with the Environment- explosion, radiation, connection/ compatibility Maintenance/ Calibration, Disposal protection from radiation, Electronic Programmable Systems & Software, Active devices and devices connected to them

Chapter III - Information Supplied with the Device

Clause number 23 of MDR and Clause Number 13 in MDD explain the information supplied with the device.

 

⇒ General requirements regarding the information supplied by the manufacturer,

⇒ Requirement of information on the label,

⇒ Sterile package label requirements,

⇒ Information in the instructions for use.

 

In Chapter III of MDR, some of the additional requirements are UDI, unambiguous time limit for using/implanting safely, electronic IFU, sterile package label requirements, Labels- human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification (‘RFID’) or bar codes.

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GSPR Checklist Template

*The GSPR Checklist template was created solely based on our technical professionals’ knowledge and skills. No objections will be entertained if Notified Bodies or other technical professionals in this field find any flaws in their work. I3CGlobal reserves all rights.

MDR GSPR Checklist : 300 USD

Template ID : MDR-GSPR-01




GSPR and Technical Documentation

The manufacturers are supposed to show evidence of fulfilment of GSPR. For this purpose, GSPR checklist requirements can be made and thus give the justification/records or evidence or a summary of how the requirements are fulfilled of each clause. The GSPR Checklist mention the following points:

  • Mention the international standard (preferably harmonized) or the Common Specification (CS) applicable.
  • Evidence and summary of how the requirements are fulfilled and demonstrate the conformity with the GSPR. The location of evidence or the records and the supporting documents.
  • Method selected to demonstrate conformity with general safety and performance requirements.
  • Justification for the clause is not applicable or not performed, if any.
  • The quality management system should provide the evidence to support relevant GSPR clauses,
  • Verification and validation reports.

How to Demonstrate Conformity through GSPR

  • The most common way is the use of harmonized standards and use of common specifications. For example, the use of EN ISO 14971, EN ISO 13485, EN ISO 60601, EN ISO 1223 etc.
  • Clinical evidence,
  • A detailed Risk analysis
  • Relevant certifications or performance test reports complying to any internationally accepted standards,
  • The quality management system should provide the evidence to support relevant GSPR clauses,
  • Verification and validation reports.

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Frequently Asked Questions

Is your technical documentation service includes GSPR?

Yes. It’s an integral part of technical documentation for all classes of medical device

Compliance with the GSPR is a fundamental requirement for obtaining MDR CE marking and placing medical devices on the EU market.

Is the GSPR to be submitted to Notified Body every year?

It’s not compulsory. Whenever there is a significant change in the technical documentation, it should be reflected in GSPR and submitted to NB.

For any major concerns of vigilance or post-market surveillance, the technical documentation must be updated and submitted to NB.