What is GSPR?        

The GSPR is known as General Safety and Performance Requirements are listed in Annex I of EU MDR 2017/745 and EU IVDR 2017/746. They are similar to the Essential Requirements under MDD 93/42/EEC.

The GSPR has 23 requirements under MDR and 20 requirements under IVDR. The manufacturers who want to get their device CE marked have to comply with these requirements and should have sufficient evidence, conformity evidence to prove that they have complied with GSPR.

Table 1: Different chapters included in GSPR

Basic overview of the chapters in GSPR

Chapter I: General Requirements

The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio.

The devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account that generally acknowledged state of the art.

This Chapter mainly focuses on:

1. Clinical safety
2. Device performance
3. Risk management evaluation
4. Benefit-risk evaluation
5. Risk reduction, and control

The risk evaluation involves establishing:

1. A risk management plan
2. Identifying and analyzing the known and foreseeable hazards associated with the device
3. Estimate and evaluate the risks associated with the intended use, and occurring during the foreseeable misuse
4. Evaluate the impact of information from the production phase and post-market surveillance system on hazards
5. Evaluate the frequency of occurrence and estimate the associated risks.

Then compare the benefits of using this device to its risks. If the product has a profile with a lot of risks but no benefit, then it is not really acceptable to certify this type of product. Benefit-risk evaluation is based on:

1. The impact analysis from risk evaluation
2. Evaluate the overall risk
3. Benefit-risk ratio, and risk acceptability
4. The risks which cannot be controlled and if it outweighs the benefits then it is the residual risks.

Based on the evaluation of the impact of information if necessary, take control measures to reduce the risk as much as possible and take adequate protection measures in relation to risks that cannot be eliminated.

Chapter II: Requirements Regarding Design and Manufacture

This chapter focuses on the Chemical, physical and biological properties, justification regarding CMR, labelling requirements for chemical, physical and biological properties, infection and microbial contamination, a device incorporating medicinal substance, a device incorporating material of biological origin, etc.

The device should be designed and manufactured to ensure the characteristics and performance requirements are fulfilled, but special attention should be paid to materials and substances used with regard to

1. Toxicity
2. Flammability
3. Biocompatibility
4. Material Properties
5. Biophysical/Modeling Research
6. Mechanical Properties
7. Surface Properties

The device should be manufactured with proper justification regarding CMR, like guidelines on phthalates and CMR. The infection and microbial contamination requirements focus on reducing infection to patients like the device should be cleaned, disinfected, and re-sterilized. The sterilization requirements require the sterile condition to be defined and packaging for sterile and non-sterile devices. The chapter also contains labeling requirements for chemical and physical properties.

As this chapter is related to the design inputs, the GSPRs provide highly-detailed requirements relating to a device’s:

• Incorporation of biological materials
• Interaction with its environment
• Ability to diagnose or provide measurements
• Radioactive properties
• Systems that are electronically programmable
• Capability for being active and connected to other devices
• Capability for being active and implantable
• Ability to withstand mechanical and thermal risks
• Ability to safely supply energy or substances to the user or patient
• Ability to be used by laypersons

Chapter III: Requirements Regarding the Information Supplied with the Device

This chapter focuses on the key information supplied by the manufacture along with the device.

Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use.

Information that has to be included in the label are:

• Device Name
• Manufacturer Name
• Contents of the Package
• UDI
• LoT Number/ Serial Number
• Manufacturing date
• Expiry date
• Batch Number
• Sterilization Information
• Precautions and Warnings
• An indication that the device contains or incorporates:
  • A medicinal substance, including a human blood or plasma derivative, or
  • Tissues or cells, or their derivatives, of human origin, or
  • Tissues or cells of animal origin, or their derivatives
• Storage and/or handling condition
• Information regarding the device if it is intended for Single Use
• If the device is custom-made, the words ‘custom-made device’

Information that has to be included on the packaging are:

• An indication permitting the sterile packaging to be recognized as such,
• A declaration that the device is in a sterile condition,
• The method of sterilization,
• The name and address of the manufacturer,
• Description of the device,
• If the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’,
• If the device is custom-made, the words ‘custom-made device’,
• The month and year of manufacture,
• An unambiguous indication of the time limit for using or implanting the device safely expressed at least in terms of year and month, and
• An instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use.

Some of the information that has to be included in the IFU are:

• The device’s intended purpose with a clear specification of indications, contra-indications, the patient target group or groups, and of the intended users
• Device Name
• Manufacturer Name
• If the device is custom-made, the words ‘custom-made device’
• The performance characteristics of the device
• Any residual risks, contra-indications and any undesirable side-effects
• Description of the device

Manufacturers should ensure they are up to date with the latest EU MDR labeling requirements. Do your device labels meet the necessary standards? Consult a Regulatory device labeling expert for a comprehensive evaluation. Stay knowledgeable and compliant.