What does the European (medical) CE mark actually mean!

[Peter Walker]

Medical CE can be recognised by the CE mark AND a 4-digit number.
The number represents the notified body that carried out the certification

Brief Guide to the European Medical Devices Directive and CE Ratings

It is a legal requirement that certain classes of goods sold in Europe (incuding medical devices) must conform to certain safety standards. A medical device cannot be legally sold in Europe unless it complies with the standards of the CE safety regulations, and in particular the Medical Devices Directive 93/42/EEC and this is confirmed by extensive auditing (ISO 9001 for manufacturers, 9002 for dealers, etc). Any device which does conform to the appropriate standards must have a CE mark clearly displayed on it. Provided that any such device does conform to the MDD/CE standards and has an appropriate CE mark attached, with the number of the notified body, it may be sold without restriction in any European country that is a signatory to the CE standards agreement. In practice this basically means countries that are part of the European Union (EU).

It is VERY important to note three things about the CE ratings

1. A European CE rating (including Medical CE) is NOT a guarantee it will cure you of anything, it is a safety rating that is certified by a system of auditing. In other words it does not guarantee that any device will actually have the medical effect as claimed. What it does confirm is is that any device sold is safe for its intended use, i.e. that it will not cause harm by electric shock, radiation, transfer of infection etc. if used according to the instructions
2. Certain classes of European Medical CE ratings are "self-certifications" by the manufacturer. They do not require any validation by a separate licensing/testing authority. This means that certain classes of Medical CE rating are no guarantee that the device even conforms to the standards it claims to, relying entirely on the honesty and integrity of the manufacturer.
3. Any medical device sold in Europe without an appropriate medical CE rating is being sold illegally

The Medical Devices Directive 93/42/EEC

This is the principal set of regulations covering medical devices in Europe. It applies to all medical devices and accessories with the exception of devices for in-vitro diagnostics and active implantable medical devices, both of which have their own separate directives.


Main Objective of the Medical Devices Directive
The main objective of the Medical Devices Directives is the protection of the health and safety of persons, and thus to prevent, as far as possible, the placing on the market and putting into service of unsafe or otherwise non-compliant products.

Assessment of Conformity to the Directive
Medical devices are divided into a number of different classes depending on the potential risk they pose to patients and/or medical staff. These are Class I, Class IIa, IIb, or III. The rules for classification are contained in Article 9 and Annex IX of the Medical Devices Directive.
For any device other than Class I, the manufacturer needs to obtain validation of the device by an independent "notified body" which will perform the actual conformity assessment. However Class I devices can be "self-certified" by the manufacturer and do not require independent testing or verification by a notified body. Article 11 of the directive sets out the rules under which given procedures must be followed.
Manufacturers are required by law to keep detailed technical records and test records that must be submitted on demand to a licensed inspection authority. However, in general, self-certified devices are not independently tested or inspected and the licensing authority will probably not inspect the records unless a complaint is received, and only serious safety breaches are usually investigated. Article 10 of the MDD sets out directives for vigilance over medical devices.

Other Requirements
Most medical devices should be supplied with a proper user manual, unless they are in Class I or Class IIa and can be used safely without any manual. There is no absolute requirement as to the language of the manual, although other European laws apply and manufacturers are technically obliged to supply manuals in any of the main languages of the countries in which the devices are sold.
When a device is deemed conformant by either the manufacturer (Class I) or the notifed body (all other classes) it is mandatory to attach a CE mark to the device.

Rife pad devices, for example, fall under Class IIa, Rule 9.

Disclaimer and Recommendations
The information provided herein is designed as a brief layperson's guide to the overall meaning of the European Medical Devices Directive and Medical CE standards. It is not an official statement of the rules and regulations, and the authors accept no liability in respect hereof. It is highly recommended that anyone who has any questions, concern or doubt about the relevance, nature or applicability of the European Medical Devices Directive and CE marking should consult the official EEC documents.

For further information see the following links:

http://www.amtac.co.uk/MDD/mdd_directive.pdf

http://www.ce-marking.org/directive-...l-devices.html

http://europa.eu.int/comm/enterprise.../meddevic.html