CE marking Medical devices & Software (93/42/EEC)

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The Medical Devices Directive 93/42/EEC

The Medical Devices Directive applies to medical devices, accessories and medical software.

Medical device is defined as instrument, apparatus, appliance, material, software or other article intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of desiases, injuries or disabilities.

CE marking medical devices

Accessory is an item whilst not being medical device is intended by manufacturer to be used together with the medical devices. Care products for contact lenses are an example of accessories.

Medical software is included in the definition of medical device. The official guideline of the European Commission (MEDDEV 2.1/6) describes medical softwareas: “Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”.

Classification Medical Devices

Medical devices must comply with essential health and safety requirements and must bear the CE marking. The applicable requirements vary depending on the classification of medical devices. Medical devices are divided into the following classes:

class I (low risk)
class IIa and IIb (middle risk)
class III (high risk)

The classification of medical devices is made in accordance with the Directive and Guidelines MEDDEV 2.4/1. Depends on the classification of medical device the conformity procedure varies.

By affixing the CE marking on medical device the manufacturer and/or importer declare that the product comply with an essential requirements of the Medical Devices Directive 93/42/EEC. CE marked medical devices can be traded freely within EEA-area.

The Medical Devices Directive does not apply to:

In Vitro diagnostic devices;
Active implantable devices;
Medicinal products;
Cosmetic products;
Human blood and products thereof;
Transplants, tissues of cells of human and animal origin.

How can Certification Company help you?

Certification Company accompanies comple CE marking for medical devices in accordance with the Medical Devices Directive 93/42/EEC. In addition to complete CE certification you can contact us for the following services:

Product classification to determine relevant requirements;
Risk analysis in accordance with the Medical Devices Directive;
Product conformity testing based on European (harmonized) standards;
Selection and guidance with a Notified Body (if applicable);
Drafting and assessing Technical Dossier;
Drafting and checking user instructions and labels;
Verifying and compiling an EU Declarartion of Conformity;
Instructions for affixing the CE marking on medical devices;

Six steps for CE marking medical devices

The Medical Devices Directive 93/42/EEC contains the legal obligations for each type of economic operators (manufacturer, importer, distributor). The following step-by-step plan has been drawn up for the manufacturer.

Product classification: defining whether the product falls into the scope of the Medical Devices Directive and classification of the medical device based on established criteria.
Economic operator classification: defining the role of economic operator within the Medical Devices Directive.
Conformity procedure: can be divided into the following parts:

- Perform product testing and/or safety assessment based on European harmonized standards;
- Draw up the procedures to ensure the conformity of series production;
- Provide identification element of the product and the economic operator;
- Provide instructions and safety information;
- Develop procedures for taking corrective measures.

Technical Files: drawing up the Technical Files (including User Manual) based on which the product conformity can be assessed.
EU Declaration of Conformity: drafting the EU Declaration of Conformity, showing that medical device complies with CE legislation.
CE marking: as soon as the product complies with the Medical Devices Directive and related standards, the CE marking will be affixed.