Drugdu.com expert's response:

When medical device enterprises prepare to enter the EU market, they often come into contact with requirements such as CE marking, MDR regulations, technical documentation and GSPR. Among them, GSPR is a particularly critical part of technical documentation preparation and product conformity assessment.

Some enterprises have already obtained the ISO 13485 quality management system certification and completed product performance tests, but when preparing EU MDR technical documents, they find that they still need to explain item by item how their products meet GSPR requirements. So what exactly is GSPR? What is its relationship with CE certification and product standards?

GSPR refers to the general safety and performance requirements for medical devices in the EU.

Its full English name is General Safety and Performance Requirements, which are specified in Annex I of the EU Medical Device Regulation (EU) 2017/745 (MDR).

To put it simply, the EU requires that medical devices under normal use conditions can achieve the intended performance declared by the manufacturer, while ensuring the safety and effectiveness of the products, and keeping relevant risks within an acceptable range. Enterprises need to prove that their products meet applicable requirements through evidence such as risk management, performance testing, clinical evaluation and technical documentation.

Annex I of MDR contains a total of 23 numbered requirements, which are divided into three parts: the first part is general requirements, mainly involving product safety, performance, risk management and benefit-risk relationship; the second part is design and manufacturing requirements, including materials, biocompatibility, infection control, sterilization, electrical safety, mechanical safety, software and other product-related risks; the third part is the information requirements provided by manufacturers, mainly involving labels, instructions for use, warning information and product usage information.

It should be noted that these 23 requirements do not mean that every medical device must meet exactly the same technical items. Enterprises should judge which requirements are applicable and which are not, and provide corresponding explanations based on the product's intended use, structural composition, risk characteristics and usage patterns.

What is the relationship between GSPR and ISO standards?

When enterprises prepare CE-related technical documents, they usually also need to consider standards such as ISO 13485, ISO 14971, ISO 10993 and IEC 60601. These standards respectively cover quality management systems, risk management, biological evaluation, medical electrical equipment safety and other aspects.

However, compliance with a certain ISO or IEC standard does not mean that all GSPR requirements have been met.

For example, an active medical device has completed applicable electrical safety and electromagnetic compatibility tests, which can provide evidence for some safety requirements, but the enterprise still needs to prove that the product's intended performance, risk management, clinical evaluation, instructions for use and labels meet corresponding requirements.

For harmonised standards that correspond to MDR-related requirements and have been published in the EU Official Journal, a presumption of conformity can be generated within their coverage. Other applicable standards can also be used as the basis for technical demonstration, but their applicability and proof scope need to be explained in combination with specific requirements.

Therefore, when organizing technical documents, enterprises need to map GSPR clauses, applicable standards and actual verification data, instead of proving that the product fully complies with MDR solely with a test report or system certificate.

How do enterprises usually prove compliance with GSPR?

In accordance with the technical documentation requirements in Annex II of MDR, manufacturers need to describe each applicable GSPR requirement, the conformity demonstration method adopted, the harmonised standards or common specifications cited, and the specific documents that can support the conformity conclusion.

In actual operation, enterprises usually establish a GSPR Compliance Checklist, which lists item by item the clause number, applicability, reasons for applicability, adopted standards or other technical methods, and corresponding verification evidence.

For example, for disposable sterile medical consumables, enterprises may need to combine data such as material safety, biocompatibility, sterilization validation, packaging integrity, shelf-life studies and labels to prove compliance with relevant requirements.

For active medical devices such as patient monitors and infusion equipment, in addition to basic performance, attention also needs to be paid to electrical safety, electromagnetic compatibility, alarm functions, software risks, usability and relevant test data.

If the product has software, network connection functions or involves patient data processing, corresponding safety and performance requirements should also be evaluated according to the specific product situation.

The GSPR Compliance Checklist cannot only be filled with "Compliant" or "Test completed". It is also necessary to clearly indicate where the evidence is. For example, a certain requirement is demonstrated through the risk management report, a certain requirement is proved through the test report, and a certain requirement is jointly supported by the clinical evaluation report and product performance studies. Only in this way can the corresponding relationship between regulatory clauses and actual technical data be established.

Can CE marking be affixed directly after GSPR compliance is achieved?

No, not yet.

Meeting applicable GSPR is an important condition for medical devices to comply with EU MDR, but enterprises still need to complete the corresponding conformity assessment procedures.

According to the product risk classification and applicable rules, some Class I medical devices can undergo conformity assessment by the manufacturer themselves; for other categories and specific Class I products, notified bodies need to participate in the assessment within the specified scope.

Enterprises also need to complete technical documentation, clinical evaluation, quality management systems and other applicable requirements, and sign the EU Declaration of Conformity as required, before they can legally affix the CE marking.

Even if the product has obtained CE marking, manufacturers still need to fulfill the obligations of post-market surveillance, risk management, adverse event reporting and necessary technical document updates. GSPR compliance also needs to be continuously evaluated based on product changes, standard updates and post-market information.

When should medical device enterprises preparing to export to the EU start organizing GSPR-related documents?

A more appropriate approach is to start identifying applicable GSPR requirements during the product design and development stage and the preparation phase for EU market access.

If you start sorting out the GSPR checklist after the product has completed R&D, testing and production, you may find that some risks lack verification, certain tests do not cover applicable requirements, or the performance statements in the instructions for use lack corresponding evidence. These problems may lead to supplementary tests, modifications to technical documents, and even re-evaluation of product design.

For enterprises that have already carried out overseas business, it is also recommended to regularly check whether the CE-related documents of existing products are still applicable, especially whether the product models, intended uses, manufacturer information, certificate coverage and relevant standard versions are consistent with the actual sold products.

On medical device B2B platforms such as Drugdu.com, when enterprises display their medical device products for export to the EU, they can specify the applicable regulations, relevant certification status, product models and the scope of technical materials that can be provided. For buyers who need further confirmation of EU market access, accurate compliance information helps both parties judge whether the products have the basis for further procurement assessment.

However, the GSPR checklist, complete technical documentation and part of the risk management data may involve enterprise technical information, which may not be suitable for full public display. Suppliers can decide which documents to provide according to the buyer's identity, cooperation stage and the nature of the materials.

For medical device enterprises, GSPR is a set of regulatory requirements that need to be implemented into specific product designs, verifications and documents. Whether the product is an ordinary medical consumable, an active medical device or other medical device, it is necessary to identify applicable clauses according to the actual situation and form traceable conformity evidence.

When preparing EU CE-related materials, enterprises should focus on checking: whether the product has completed applicable GSPR identification, whether risks have been fully assessed, whether relevant tests and clinical evidence are complete, and whether the technical documents can accurately correspond to various requirements.

Only by implementing these requirements into products and technical documents can a reliable foundation be provided for subsequent conformity assessment and EU market access.