General Safety and Performance Requirements for medical devices

The General Safety and Performance Requirements (GSPR) for medical devices are key safety and performance requirements that medical devices must fulfil in order to be placed on the market in the EU.

The most important points from Regulation (EU) 2017/745 (Medical Device Regulation, MDR) are as follows:

1. They are set out in Annex I of the MDR as "Genaral Safety and Performance Requirements".
2. They replace the previous "Essential Requirements" of the Medical Device Directive (Directive 93/42/EEC, MDD, valid until 2021) and the MEDDEV documents of the European Union for practical guidance on implementation.

This document addresses the main aspects of the General Safety and Performance Requirements (GSPR) in the relevant chapters and sections:

Chapter I

- General requirements, including safety and risk management.

Chapter II

- Chemical, physical and biological properties;

- Infection and microbial contamination;

- Products containing materials of biological origin

- Manufacturing of products and interactions with their environment

- Products with diagnostic or measuring functions

- Radiation protection

- Programmable electronic systems

- Active products and associated products - non-implantable

- Specific requirements for active implantable products

- Protection against mechanical and thermal risks

- Protection against risks to patients or users from products that emit energy or substances

- Protection against risks from medical devices intended for use by laypersons.

Chapter III

Requirements for information provided with the product.

1. Manufacturers must demonstrate the conformity of their products with these requirements, often by applying additional harmonised standards.

2. These requirements form the basis for the CE marking and market authorisation of medical devices in the EU.

3. Similar concepts exist in other countries, such as the 'Essential Principles' in Australia or 'General Controls' and 'Special Controls' in the USA, defined and regulated by the Food and Drug Administration (FDA) in the Code of Federal Regulations (CFR) Title 21, Parts 800-1299.

4. Compliance with these requirements must be documented in the product's technical documentation.

The General Safety and Performance Requirements, as defined in Annex I of the EU Medical Device Regulation (MDR), provide the foundation for the safety and performance of medical devices and must be met by all manufacturers.

Compliance with these requirements must be demonstrated through appropriate conformity assessment procedures, where the application of harmonised standards or common specifications plays a crucial role in demonstrating compliance with regulatory requirements.

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