How compliance with GSPRs is demonstrated
First and foremost, alignment with General Safety and Performance Requirements is reflected in the technical documentation and the manufacturer's quality management system documentation. These documents are pivotal components of the entire process of ensuring and demonstrating compliance. They contain detailed information about the development, production, quality control, risk management, and clinical assessment of medical devices.
Therefore, when creating technical documentation and quality management system documentation, it is essential to have a clear understanding of which specific GSPRs are applicable to your medical devices and how you can demonstrate compliance with these GSPRs. In this regard, one of the initial documents in the technical file worth developing is a GSPR matrix - a document that provides a list of the key requirements in tabular form, along with justifications for why each of them is applicable or not applicable to your product.
The Difference Between GSPR and Essential Requirements
The concept of General Safety and Performance Requirements emerged in European regulation with the enforcement of Regulation MDR 2017/745 and Regulation IVDR 2017/746. Prior to this, Europe used the term "Essential Requirements," as presented in Directives MDD 93/42 (medical devices), IVDD 98/79 (in vitro diagnostic devices), and AIMDD 90/385 (active implantable medical devices).
The Essential Requirements (ER) of MDD/IVDD were outlined in two chapters of Appendix I to these directives, comprising 13 points. Meanwhile, GSPR is presented in three chapters of Appendix 1 in MDR/IVDR and encompasses 23 points. Therefore, with the transition to the new legislation, the approach to the requirements of efficacy and safety of medical devices has fundamentally remained unchanged. However, the volume of requirements has significantly increased, as GSPR covers many aspects that were not addressed in the Essential Requirements. Specifically, the list of GSPR requirements includes:
- Requirements for devices containing medicinal substances.
- Special requirements for products containing tissues of human or animal origin.
- Disposal requirements.
- Information security requirements.
- Requirements for devices intended for use by non-professionals.
- General requirements for labeling.
GSPR - Structure and Content
The General Safety and Performance Requirements outlined in Annex I of the European Regulations MDR and IVDR are divided into three chapters.
Chapter 1 - General Requirements
The general requirements for effectiveness and safety, as outlined in the MDR and IVDR, include:
- Manufacturers and developers must implement all necessary measures to protect patients and users in cases where it is not possible to completely eliminate risks.
- Risks associated with the medical device must be minimized, but not to the extent that it adversely affects the benefit-risk ratio.
- Devices must operate in accordance with their design and intended function. They must not pose a threat to the health or safety of the patient, user, or any other individual.
- Manufacturers must maintain a risk management system that will be continuously updated throughout the product's service life.
- Patients and users must be provided with information about any potential risks. This information must be clear, easy to understand, and take into account the technical knowledge level of the users.
- Developers and manufacturers must take all possible measures to minimize the negative consequences of using the product. They must also ensure that potential risks are acceptable compared to the potential benefits of the product for users.
- Products must withstand the loads arising from normal operation throughout their service life. Products must be designed, manufactured, and packaged in a way that ensures protection from damage during transportation and storage.
Chapter 2 - Requirements for Design and Production
Chapter 2 of the MDR/IVDR outlines the GSPR related to design and production. It specifically covers the following aspects:
- Chemical, physical, and biological properties
- Potential for microbial contamination
- Use of substances considered medicinal products
- Use of biological materials
- Interaction with the environment
- Ability for diagnosis or measurement
- Radioactive properties
- Programmable systems
- Active devices and devices connected to other equipment
- Active implantable devices
- Ability to withstand mechanical and thermal stresses
- Ability to safely deliver energy or substances to the user or patient
- Ability to be used by non-professionals.
Within each of these GSPR requirements, key aspects are defined that developers and manufacturers must take into account.
Chapter 3 - Requirements for Information Provided to Users with the Product
The final chapter of Appendix I addresses the information that the manufacturer must provide to the user along with the product. The key requirements for this information are formulated as follows: "Each medical device must be equipped with all necessary information for the identification of the device and its manufacturer, as well as all accompanying safety and technical characteristic information that is important for the user." Chapter 3 of the regulation describes exactly what information should be present:
- On the product packaging.
- In the instructions.
- For sterile products - on the device packaging designed to maintain its sterility.
Conclusion
General Safety and Performance Requirements (GSPR) constitute a set of fundamental criteria that medical devices must meet in order to be placed on the European market. These requirements are outlined in Annex I of the MDR and IVDR and are foundational in ensuring the safety, effectiveness, and quality of medical devices within the European Union.
The responsibility of adhering to GSPR lies with every manufacturer of medical devices distributing their products within the European Union, regardless of the category or class of the device. These criteria must be upheld throughout the entire lifecycle of the device, which must be meticulously documented. GSPR necessitates a systematic approach. Both technical documentation and quality management documentation must explicitly demonstrate compliance with GSPR.
