Essential Requirements
What are the general technical requirements to bring my medical device product to the European market?
Council Directive 90/385/EEC
(5 September 2007)
ANNEX I
ESSENTIAL REQUIREMENTS
II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
Product Labelling
11. The devices and, if appropriate, their component parts must be identified to allow any necessary measure to be taken following the discovery of a potential risk in connection with the devices and their component parts.
12. Devices must bear a code by which they and their manufacturer can be unequivocally identified (particularly with regard to the type of device and year of manufacture); it must be possible to read this code, if necessary, without the need for a surgical operation.
13. When a device or its accessories bear instructions required for the operation of the device or indicate operating or adjustment parameters, by means of a visual system, such information must be understandable to the user and, as appropriate, the patient.
14. Every device must bear, legibly and indelibly, the following particulars, where appropriate in the form of generally recognized symbols:
14.1. On the sterile pack:
- the method of sterilization,
- an indication permitting this packaging to be recognized as such,
- the name and address of the manufacturer,
- a description of the device,
- if the device is intended for clinical investigations, the words: ‘exclusively for clinical investigations’,
- if the device is custom-made, the words ‘custom-made device’,
- a declaration that the implantable device is in a sterile condition,
- the month and year of manufacture,
- an indication of the time limit for implanting a device safely.
14.2. On the sales packaging:
- the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,
- a description of the device,
- the purpose of the device,
- the relevant characteristics for its use,
- if the device is intended for clinical investigations, the words: ‘exclusively for clinical investigations’,
- if the device is custom-made, the words: ‘custom-made device’,
- a declaration that the implantable device is in a sterile condition,
- the month and year of manufacture,
- an indication of the time limit for implanting a device safely,
- the conditions for transporting and staring the device,
- in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.
15. When placed on the market, each device must be accompanied by instructions for use giving the following particulars:
- the year of authorization to affix the CE mark,
- the details referred to in 14,1 and 14.2, with the exception of those referred to in the eighth and ninth indents,
- the performances referred to in section 2 and any undesirable side effects,
- information allowing the physician to select a suitable device and the corresponding software and accessories,
- information constituting the instructions for use allowing the physician and, where appropriate, the patient to use the device, its accessories and software correctly, as well as information on the nature, scope and times for operating controls and trials and, where appropriate, maintenance measures,
- information allowing, if appropriate, certain risks in connection with implantation of the device to be avoided,
- information regarding the risks of reciprocal interference ( 13 ) in connection with the presence of the device during specific investigations or treatment,
- the necessary instructions in the event of the sterile pack being damaged and, where appropriate, details of appropriate methods of resterilization,
- an indication, if appropriate, that a device can be reused only if it is reconditioned under the responsibility of the manufacturer to comply with the essential requirements.
The instruction leaflet must also include details allowing the physician to brief the patient on the contra-indications and the precautions to be taken. These details should cover in particular:
- information allowing the lifetime of the energy source to be established,
- precautions to be taken should changes occur in the device’s performance,
- precautions to be taken as regards exposure, in reasonably foreseeable environmental conditions, to magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure, acceleration, etc.,
- adequate information regarding the medicinal products which the device in question is designed to administer,
- date of issue or the latest revision of the instructions for use.
16. Confirmation that the device satisfies the requirements in respect of characteristics and performances, as referred to in I. ‘General requirements’, in normal conditions of use, and the evaluation of the side effects or undesirable effects must be based on clinical data established in accordance with Annex 7.