With its implementation, EU MDR has put forth a lot of new requirements for medical device manufacturers. One of these requirements concerns the manufacturers trying to get a CE mark for their devices. These requirements are set forward by GSPR, or General Safety Performance Requirements.
What is GSPR?
GSPR is a set of requirements in Annex I of EU MDR 2017/745 and EU IVDR 2017/746. Under MDR, the GSPR presents the manufacturer with 23 requirements. While under IVDR, it presents 20 requirements. Thus, the manufacturers who want to obtain the CE mark have to:
- Show compliance to the GSPR requirements present in MDR and IVDR,
- Show sufficient evidence and conformity evidence to prove their compliance to the GSPR
The Chapters of GSPR
The Chapters of GSPR (in MDR)
- Chapter 1 – General Requirements (1 to 9)
- Chapter 2 – Design and Manufacturing (10 to 22)
- Chapter 3 – Labels and IFU (23)
The Chapters of GSPR (in EU IVDR)
- Chapter 1 – General Requirements (1 to 9)
- Chapter 2 – Performance, Design and Manuf. (9 to 19)
- Chapter 3 – Labels and IFU (20)
What Are the Requirements of GSPR?
The chapter-wise requirements of GSPR are as follows:
Chapter 1 – General Requirements
This Chapter presents general requirements applicable to all medical devices. Its primary focus is on the following:
- Clinical safety
- Performance of the device
- Benefit-risk evaluation
- Risk management evaluation
- Risk reduction, and
- Control
Performance of the Medical Device
Medical device performance should prove how optimum it can perform while posing minimal risk to the patient or user’s health. Also, transport or storage must not adversely affect the device’s performance. Thus, the manufacturer will have to use a documented device to prove the device’s compliance.
Risk Evaluation
The manufacturer has to involve the following in risk evaluation:
- A risk management plan
- Identification and analysis of the known foreseeable hazards associated with the device used
- Risk estimation and evaluation associated with the intended use and occurring during the foreseeable misuse
- Evaluation of the information’s impact from the production phase and post-market surveillance system on the device’s hazards
- Evaluation of how frequent the risks occur and estimation of the associated risks
The Benefit-Risk Evaluation
. The benefit-risk evaluation is based upon the following:
- Risk evaluation’s impact analysis
- Evaluation of overall risk
- Benefit-risk ratio
- Risk acceptability, and
- The risks that are impossible to be controlled
The benefit-risk evaluation allows the manufacturers to compare the device’s benefits with its risks. A product with many risks but no benefits can be difficult to get a CE certification.
By evaluating the impact of information and taking control measures, a manufacturer can take control measures for risk reduction as much as possible. The manufacturer should also take adequate protection measures for the risks that are impossible to eliminate.
Finally, Chapter I of GSPR also mentions Annex XVI products. The manufacturer must also identify if the concerned product is part of Annex XVI products since these products are also required to show compliance with GSPR.
Chapter II – Design and Manufacturing Requirements
The focus points of this Chapter are
- Chemical properties
- Biological properties
- Physical properties
- Labeling requirements for chemical, biological, and physical properties
- CMR justification
- Infectious and microbial contamination
- The device contains medicinal substances, and
- Devices having material of biological origins, etc.
Medical device manufacturers must design their devices to fulfill the requirements of GSPR Chapter I. However, special attention must be paid to the materials and substances concerning:
- Biocompatibility
- Biophysical/modeling research
- Flammability
- Material properties
- Mechanical properties
- Surface properties, and
- Toxicity
Justification of CMR Requirements
Another essential requirement of GSPR Chapter II concerns the production of medical devices that justify CMR and guidelines on phthalates.
Sterilization Requirements
The focus of infection and microbial contamination requirements is to reduce the chances of infection in the patients. For this purpose, the medical device must be cleaned, sterilized, and re-sterilized. Also, these requirements require the sterile condition to be defined for sterile and non-sterile devices. The Chapter’s content also deals with the labeling requirements for physical and chemical properties.
Requirements for Device’s Design
Regarding the device’s design, the GSPR puts forward the requirements concerning:
- Biological materials incorporation
- Device’s interaction with its environment
- The ability to diagnose or provide measurements
- Radioactive properties of the device
- Electronically programmable systems
- Device’s capability of being active and getting connected to other devices
- Device’s capability of being implantable and active
- The capability of withstanding thermal and mechanical risks
- The ability of the device to supply substances or energy safely to the patients or the users, and
- Its ability to be used by common men who do not know much
Chapter III – Labels and IFU
This Chapter focuses on the information to be supplied by the medical device in the form of a label, IFU (Instructions for Use), and via the packaging that maintains the device’s sterile condition.
Performing the GAP Assessment for GSPR
Under GPR, the GAP assessment for any new product can be done in three steps as follows:
Step 1: GAP Analysis As Per EU MDR
GAP analysis is performed in this step according to the MDD 94/42/EEC checklist. If the checklist requirements apply to the manufacturer’s product, he should collect the evidence from design input files, proving that he has fulfilled the requirements. A gap will be considered upon a lack of information to prove the requirement.
Step 2: GAP Analysis As Per the Relevant ISO Standards
In this step, gaps are analyzed according to the ISO standards concerning the product. These ISO standards must be mentioned in documents, such as:
- ERC (Essential Requirements Checklist)
- CER (Clinical Evaluation Report), and
- PRD (Product Requirement Document)
Not mentioning the ISO standards in these documents will be considered a gap.
Step 3: GAP Analysis As Per the GSPR
This is the last step in performing GAP analysis for GSPR, where gap analysis is conducted following the GSPR. If these requirements conform to the manufacturers’ product, he should collect the evidence across the design input documents to prove that they have fulfilled the requirements. Not having enough evidence in this regard will be considered a gap.
Clinical Evaluation Report
A clinical Evaluation Report (or CER) for medical devices is a document containing the conclusions of the clinical evaluation performed on medical devices according to the relevant clinical data. As mentioned, medical device manufacturers willing to market their devices in the EU must prove their devices’ compliance with GSPR.
MDR Article 5.3 states that “Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation in accordance with Article 61.”
Every manufacturer needs to determine which data in their clinical evaluation covers which requirement of the GSPR. But, in principle, such relevant data should satisfy safety and performance aspects. Also while designing and developing a new device, defining the benefit-risk analysis would be one of the first design activities.
In this regard, the clinical evidence from clinical evaluation shall be
- Recorded in the CER, and
- It shall be a part of technical documentation supporting the conformity assessment of the device
Together, the CER and clinical data will prove the device’s conformity to the GSPR.
What Details are Present in the CER?
The CER contains the following details regarding the medical device:
- Clinical background
- Current knowledge
- State of the art for evaluating the device’s safety performance against its intended purpose
- Details of post-market activities use for responding to any unanswered questions or residual risks that the clinical data have not covered, and
- Results of various tests to prove the device’s safety and performance
How is Conformity to GSPR Established in CER?
In CER, conformity to GSPR is established by assessing safety requirements, performance, acceptability of benefit, risk profile, and side effects.
What are the Contents of CER’s Conclusion?
The CER’S concluding contents include:
- Acceptability of the risk-benefit profile under current knowledge (or State of the art) in medical fields
- Acceptability of the risk-benefit profile under the available medical alternatives, and
- Adequacy of the information of the materials supplied, whether their intended purpose and risk reduction measures were optimum or had any discrepancies
Summary of the CER
The summary of the CER includes the following;
- Device’s suitability and IFU for the intended users and usability aspects
- Any discrepancies, and
- Adequacy of claims and their discrepancies
While preparing the summary of the CER, discrepancies should be summarized if consistency is found between the clinical data, information materials, and the risk management documentation for the device being evaluated.
What Purpose Does CER Serve for the Medical Device Manufacturers?
With the CER, the medical device manufacturers can prove that their devices are safe for human use and perform as expected according to the manufacturer’s instructions. The CER also justifies the medical devices’ presence on the market as it displays that the benefits of the device outweigh its risks. Let us know if you have any requirements, you can send your inquiries to us.
