Medical Devices Directive – 93/42/EEC
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Conformity with the Medical Devices Directive is a mandatory requirement for CE marking your medical device to access to the European Single Market.
The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In vitro Diagnostic Medical Devices Directive. In order to obtain medical device approval in the EU, medical devices must be correctly classified. The MDD divides products into different classes, based on risk and intended use, which determines the relevant conformity assessment procedure.
For products classified with medium to high degree of risk (class Is, Im, IIa, IIb and III) the Medical Device Directive requires a conformity assessment procedure involving a notified body.
Medical Devices Directive – 93/42/EEC MDD and subsequent amendments.
Products within the Scope of MDDArticle 1 of the Directive defines a ‘medical device’ to mean any instrument, apparatus, appliance, software, 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;
In addition, the scope includes an ‘accessory,’ which means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used.
Basic Technical Concepts
The Medical Devices Directive outlines the minimum requirements for ensuring the safety and performance characteristics for Medical Devices in the European market. It is founded on the following basic principles:
- The Essential Requirements – Annex I – which outlines the necessary precautions and requirements to be considered in the design, manufacturer, use and disposal of Devices.
- Classification of Devices and Conformity Assessment Procedures based on the level of Risk inherent in the Device
- Control of Production to ensure Conformity to Type
- Monitoring and Vigilance
Manufacturers of Medical Devices should demonstrate conformity to all requirements listed within the Directive, Recommendations and Implementing Regulations, in addition to the requirements in subsequent guideline documents (MEDDEVs).
For many of the common techniques and product types there exist harmonized standards, listed in the reference links below. While use of a harmonized standard is not always mandatory, it is highly recommended as it represents best practice and technical state of the art, which can be used as a presumption of conformity to the relevant part of the directive. If a manufacturer chooses not to follow a harmonized standard, they must be able to demonstrate clearly how the product meets the relevant safety or performance requirements.
The compliance routes available to be able to CE mark your device, in accordance with the Medical Devices Directive, depend on the classification of your device.
It is not practical or feasible to apply the most rigorous conformity assessment process to all types of devices. Instead a graduated level of control is applied which categorizes devices based on the level of inherent risk or potential hazards.
Correct classification is therefore critical before commencing a compliance assessment. Guidance on correct classification of your device can be found in the European Commission Guidance Document MEDDEV 2.4/1 - Classification of Medical Devices.
Irrespective of the classification, all devices must still conform to the basic principles of the directive (the Essential Requirements); be subject to reporting requirements under the post-market surveillance vigilance system, and, bare a CE mark.
Class I Devices:
Class I Devices follow a Self-Declaration of Conformity route, unless the device is sold as sterile (Class Is) or has a measurement function (Class Im.) In these cases, the involvement of a Notified Body is required.
Class IIa and IIb Devices:
Class IIa and IIb Devices require the services of a Notified Body to approve the Declaration of Conformity through a conformity assessment.
Class III Devices:
Class III Devices represent the highest risk and are evaluated by a specialist team of assessors within the notified body.
Several different conformity assessment routes are available to the manufacturer, based on their preference and individual requirements. The most common approach is Annex II. Once you have been issued with a certificate by the Notified Body, you may affix CE marking to your device and place it on the market. Most member states also require you to register your device with the relevant national authorities.
Compliance Routes Graphic (Click the image to open larger version)
Conformity Assessment Routes – MDD Class IIa
Conformity Assessment Routes – MDD Class IIb
Conformity Assessment Routes – MDD Class III
What services do we offer?
We offer notified body services through Presafe Denmark AS (Notified Body 0543.) as a notified body for all medical devices under the quality modules of the Medical Devices Directive, annexes II and V. We can assess and certify your quality system so that you can affix the CE mark to your products according to MDD.
Our services include:
- Pre-Assessment and Gap-Assessment Services, especially useful for first-time manufacturers designing a product intended for certification under the MDD.
- Technical documentation/file or design dossier assessment/review for CE marking of Medical Devices.
- Quality assurance (Production and/or Full) equivalent to ISO 13485