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General Safety and Performance Requirements (GSPR)

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Within the EU Medical Device Regulation 2017/745, the essential requirements (ER) which were the core of the previous medical device directives (MDD) have been replaced by the so-called General Safety and Performance Requirements (GSPR). Each manufacturer shall provide evidences of compliance to the GSPR; in general GSPR are quite similar to the previous Essential Requirements of the MDD, although some specific new requirements and topics have been introduced.

The concept of having specific minimum essential product characteristics is relatively common among medical device regulations globally. Similar lists of product characteristics are present as well in the Canadian and Australian medical device regulations, where they are called “essential principles” .

The EU MDR 2017/745 contains 23 GSPR that are divided into three main categories that are reported in the Annex I:

  • Chapter 1 – General requirements (1 to 9)
  • Chapter 2 -Design and Manuf. (from 10 to 22)
  • Chapter 3 –Labels and IFU (23)

In this article we will mainly talk about the General Requirements (Safety and Performance Requirements from 1 to 9), and we will discuss the other reauirements in a different post.

Section 1 of GSPR: General Requirements

Let’s start to have a look to the General Safety and Performance Requirements listed in the EU MDR 2017/745.

GSRP 1: Performance and Safety

This first safety and performance requirement is indeed related to the necessity have the device designed in such a way it does not cause any safety issue to patient, user or any other person. Specifically, the requirements is related to the suitability and safety of the device according to their intended purpose. Moreover, independently from the specific intended purpose of the device, the risk associated to the device shall always be acceptable when weighed against the benefits to the patient.

GSRP 2: Reduction of Risks

The second Safety and Performance requirement is related to the reduction of risk as far as possible, without however affecting the benefit-risk ratio. Sometimes, risks could be further reduced by changes in design, but important benefits and/or device performance may also be compromised by these changes, thus impacting the risk-benefit ratio.

GSRP 3: Risk Management System

This Safety and Performance Requirement, as it can be deduced from the title, is related to risk management activities. It is clearly stated that risk management process, as expected according to ISO 14971, shall be a continuous activities through the whole lifecycle of the product.

The regulation specifies very well what are the activities that need to be performed in the framework of risk management. For example, among these activities, we can find:

  • the necessity to establish a risk management plan for each type of device.
  • the identification and analysis of all the known and foreseeable hazards associated with each device
  • Estimation and evaluation of the risks linked to the hazards identified
  • The elimination or control of these risks
  • The evaluation of production and post-production information in order to make sure risk estimation is always up to date.
  • The re-evaluation of the risk control measure, if deemed necessary after collection of production and post-production information

All this step may sound familiar if the organization has already a risk management process in place that is aligned with the requirements of ISO 14971 and ISO 24971.

GSPR 4: Risk control measures and residual risks

This Safety and Performance Requirements is still linked to the risk management process.

Specifically, it deals with the concept of having the overall residual risk and the risk associated to each hazard evaluated and judged to be acceptable.

Moreover, the MDR in the contest of SPR 4 requires that “Manufacturers shall inform users of any residual risks“. The interpretation of this statement is somehow not very clear, but it may be interpreted with the necessity to include in the Information for users all residual risks, including foreseeable adverse evens and side effects identified through the risk management process.

The text of the fifth Safety and Performance is the following:

In eliminating or reducing risks related to use error, the manufacturer shall: 

(a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and

(b) give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users).

This basically deals with the a particular class of risks, the risk linked to use errors. This requirements is highly linked to the usability process and the compliance with the ISO 62366. The usability or human factor evaluation is highly linked with the risk management process and user-related risks shall be carefully identified, evaluated and mitigated as much as possible.

GSPR 6: Device lifetime

In the Safety and Performance Requirement it is established the necessity to have the characteristics and performance of the device maintained through the whole lifetime. Safety of the device shall also be maintained when reasonably foreseeable maintenance or storage errors have been performed or under abnormal (stress) conditions.

GSPR 7: Packaging, transport, storage

Here below is what it is mentioned for the specific Safety and Performance Requirement:

Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer.

Basically, it is essential that manufacturing process and packaging are able to protect the device characteristics during transportation and storage.

GSPR 8: Risk-benefit ratio

This is another point that is directly linked to the risk management process and compliance with ISO 14971. Specifically, on this specific point the MDR requires:

  • The minimazion of all the identified risks, meaning that each risk shall be reduced as far as possible, even risks that since the beginning are deemed acceptable.
  • All the risks shall deemed acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use.

We have been discussing in details about the risk benefit analysis and how it shall be organised from a documentation standpoint.

GSPR 9 : Devices without a medical purpose

Annex VXI of the EU MDR 2017/745 provides a specific list of a particular type of devices named “Devices without a Medical Purpose”.

The MDR clarifies that these devices shall be compliant with GSPR from 1 to 8; moreover it is clearly mentioned that the devices ‘shall not present any risk’ or ‘no more than the maximum acceptable risks’ consistent with a high level of protection for safety and health.

Devices without an intended medical purpose will need to demonstrate compliance with CSs which will address, at the very least, the application of risk management and, where necessary, clinical evaluation regarding safety.

Conclusions

In conclusion, we went through the first group of General Safety and Performance Requirements for the EU MDR 2017/745. It is worth to highlight once again the importance of the GSPR for compliance to the MDR requirements; the demonstration of GSPR compliance is a key point for the CE marking process and for the technical dossier of any medical device ready to enter in the European Market.

QualityMedDev GSPR Checklist

QualityMedDev has made available a GSPR checklist that will help you to ensure compliance of your devices and related documentation with the safety and performance requirements for the EU MDR 2017/745. This is a 50 pages word document, fully editable and customazible according to your need. The first page of the document provides some general instructions on how to use the checklist and how to align it based on the type of medical device under assessment.

Do not hesitate to download the product!

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Source: https://www.qualitymeddev.com/2021/08/17/gspr/

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