Fulfilling the general safety and performance requirements listed in Annex I is one of the most fundamental preconditions to placing any medical device on the European market. See Article 5.2 “Placing on the market and putting into service”. The "requirements" are set of product characteristics, considered by the European authorities as being essential to ensuring that any new device will be safe and perform as intended throughout its life.
The concept of specifying minimum essential product characteristics is quite common among medical device regulations globally. Similar lists of product characteristics also feature in the Canadian and Australian medical device regulations, where they are called “essential principles” .
The author’s assumption is that most medical device developers will follow the design and development methodology ISO 13485, or the design control methodology of the United States’ 21 CFR, or similar. In that case, the requirements listed in Annex I will represent only a small proportion of the total number of physical and performance characteristics of the intended medical device. Nevertheless, they are an important subset of the product design requirements. Requirements which all European authorities will expect a device developer to be able to show evidence of fulfilment. For this reason, most developers will prepare and keep up to date a “checklist”; listing each of the general safety and performance requirements, a short summary of how the requirements are fulfilled or explanation why the requirement is not applicable, references to documented evidence. In many cases, the most straightforward way of fulfilling these requirements will be to ensure the device conforms to an applicable harmonised European standard (norm). For more information consult the dedicated page on harmonised standards.
To understand the full scope and detail of the European general safety and performance requirements, the reader is directed to read Annex I of the Regulation. The list below is a high level summary provided for information and intended only to illustrate the range of topics covered:
Chapter I - GENERAL REQUIREMENTS.
- Eiminate or reduce risks as far as possible, take protection measures in relation to risks that cannot be eliminated, provide information for safety and, where appropriate, training to users.
- Inform users of any residual risks.
eliminating or reducing risks related to use error,
- The characteristics and performance shall not be adversely affected during the lifetime of the device,
- The characteristics and performance are not adversely affected during transport and storage,
- All known and foreseeable risks shall be acceptable when weighed against the evaluated benefits to the patient and/or user,
Chapter II - REQUIREMENTS REGARDING DESIGN AND MANUFACTURE
- Chemical, physical and biological properties,
- Infection and microbial contamination,
- Devices incorporating a medicinal product or substances absorbed by the human body,
- Devices incorporating materials of biological origin,
- Construction of devices and interaction with their environment,
- Devices with a diagnostic or measuring function,
- Protection against radiation,
Electronic programmable systems,
- Active devices and devices connected to them,
- Particular requirements for active implantable devices,
- Protection against mechanical and thermal risks,
- devices supplying energy or substances,
- medical devices intended by the manufacturer for use by lay persons.
Chapter III - INFORMATION SUPPLIED WITH THE DEVICE
- General requirements regarding the information supplied by the manufacturer,
- Information on the label,
- Information on the packaging which maintains the sterile condition of a device,
- Information in the instructions for use.