SubscribeThe possibility to access the whole European Economic Area (EEA) market by means of a single registration procedure is given by CE marking. Currently the European directive on medical devices is being updated.
In Europe CE marking of medical devices is regulated by three directives:
- Directive 93/42/EEC: Directive on medical devices (changed by directive 2000/70/EC and directive 2001/104/EC and directive 2007/.../EC) as amended by 2003/12/EC: Directive on re-classification of breast implants.
- 2003/32/EC: Directive with respect to medical devices manufactured utilising tissues of animal origin.
- 2005/50/EC: Directive on the reclassification of hip, knee and shoulder joint replacements.
- Directive 90/385/EEC: Directive on active implantable medical devices
- Directive 98/79/EC Directive on In vitro Diagnostics
These directives have been implemented in national law, e.g. the latest version in Germany by 30.June 2007. According to article 1.2 (a) of Directive 93/42/EEC medical device means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. Also medical devices are products which contain additionally a pharmaceutical active ingredient, and which may in assistance to the function of the medical device achieve an effect on the human body, or devices, which contain blood- or blood plasma derivates or which are In Vitro Diagnostics according to article 1.2 (c), 1.3 and 1.4.
Every manufacturer has to demonstrate in a conformity assessment procedure for the medical device that it conforms to the essential requirements (e.g. technical documentation, risk management file). These are supported by harmonized standards and serve as proof of safety.
After successful conclusion of the procedure the manufacturer is allowed to attach the CE mark to the medical device and to market it. According to article 9 in association with Annex IX MDD 93/42/EEC medical devices are - as far as they are not In Vitro Diagnostics or active implantable medical devices - classified in four classes (I, IIa, IIb, III).
Classification determines the kind of conformity assessment. Depending on the product class one of the procedure laid down in article 11 MDD 93/42/EEC has to be followed. Due to the supposed low risk level, for class I devices the conformity assessment procedure generally is conducted on the sole responsibility of the manufacturer. Nevertheless the manufacturer should have a technical documentation including the risk management file available. For class IIa devices the production process underlies inspections by a "notified body".
For these products a technical documentation including risk management file has to be compiled, too. Devices falling within class IIb and III constitute a high risk potential and are therefore inspected by a notified body with regard to the design and manufacture of the devices. For class IIb devices the technical documentation, which includes inter alia the risk management file and a preclinical and clinical assessment, are checked, as a general rule, during the audit inspection for the company certification.
The technical documentation of class III devices has to be submitted to the notified body. Clinical studies may be necessary, especially for innovative products. When the medical device contains an active pharmaceutical ingredient, a consultation procedure is scheduled. After positive inspection of class III devices a product certificate is issued, qualifying for marketing of class III devices. For products classified as class IIa, IIb, or III, a quality management system (QMS) has to be assessed, certified and monitored by a notified body.
The certificate which is issued after positive inspection must refer to one of the Annexes II, IV, V, or VI of MDD. An additional certification according to the harmonized standard ISO 13485 is optional but recommendable. The responsibility and liability is totally up to the responsible manufacturer.
The "notified body" assesses mainly if the manufacturer has established and maintains a suitable Quality Management System (QMS) and if this system is operational and if all necessary results and documentation are determinable. Therefore it is in the interest of the manufacturer to be informed about the legal requirements at an early stage and to consider them from the outset in device design and manufacturing. PharmaLex would like to consult and guide you through the whole conformity assessment procedure and in all device classes - active and non active medical devices as well as In Vitro Diagnostics.
What can we do for you?
PharmaLex International supports you in
- Classifying your medical devices.
- Wording of intended purpose.
- Compilation of the technical documentation.
- Compilation of the risk management file.
- Design and implementation of clinical studies.
- Clinical assessment on the basis of scientific literature.
- Communication with notified bodies.
- Accomplishment of consultation procedure.
- Registration procedures world wide.
