Compliance with the Medical Devices Directive is a mandatory requirement for CE representation of medical devices entering the European single market.

The    Medical Devices Directive (MDD) applies to all general medical products except active implantable medical products and in vitro diagnostic medical products. Product classification needs to be done correctly if it is to comply with the Medical Device Directive (MDD). In order to gain access to the EU, medical devices must be accurately classified. The MDD classifies products into different categories based on risk and intended use, and determines the relevant conformity assessment procedures.

   For products in the medium and high risk categories (class Is, Im, IIa, IIb and III), the Medical Device Directive requires a conformity assessment procedure involving a Notified Body (NB).

  Related legislation

   Medical Devices Directive – 93/42/EEC MDD and subsequent amendments.

  MDD Directive Applicable Products

Article 1 of the Directive defines a "medical device", the intended use of which is intended for use in humans for one or more of the following specific purposes, whether used alone or in combination as an instrument, device, appliance, machine, appliance, implant , in vitro reagents or calibrators, software, materials or other similar or related items. These purposes are:

   diagnose, prevent, monitor, treat or alleviate disease,

   diagnose, monitor, treat, mitigate or compensate for injury or disability,

   investigate, replace or modify anatomical or physiological processes,

   pregnancy control,

  The main designed effect on the human body surface or in the body is not obtained by pharmacological, immunological or metabolic means, but these means may be involved and play a certain auxiliary role. In addition, the scope also includes "accessories", which are not medical devices used alone, but components designed by the manufacturer to be used in conjunction with other medical devices.

  Basic Technical Concepts

The   Medical Devices Directive sets out the minimum requirements to ensure the safety and efficacy of medical devices on the European market. The basic principles of the Directive are as follows:

  Basic Requirements for Safety and Effectiveness - Annex I - specifies precautions and requirements that must be considered in the design, manufacture, use and disposal of medical devices

  Classification of equipment and conformity assessment procedures according to the level of risk inherent in the equipment

  Control production to ensure products meet

  Monitoring and Alerting System

   Manufacturers of medical devices should demonstrate compliance with all requirements listed in Directives, Recommendations and Codes of Practice, as well as those in subsequent guidance documents (MEDDEVs). It can be difficult to fully understand the conformity assessment process, so DNV GL offers a range of pre-assessment services to help manufacturers identify and understand these requirements.

   For many common technologies and product types, harmonized standards exist, as shown in the following reference links. Although the use of the harmonized standard is not mandatory, it is strongly recommended as it represents the best practice and best technology at the current state of the art and can be used as a presumption of compliance with the relevant parts of the directive. If manufacturers do not choose to comply with harmonized standards, they must clearly demonstrate how their products meet the relevant safety or efficacy requirements.

   Compliance Path

   According to the Medical Device Directive, the compliance route available to you to mark your device for CE depends on the class of your device.

   It is impractical and impractical to apply the most stringent conformity assessment procedures to all types of devices. Therefore, a step-by-step approach to control is used to classify equipment according to the level of inherent risk or potential hazard.

   Therefore, correct classification is crucial before starting a compliance assessment. Guidance on the correct classification of your device can be found in the EU guidance document MEDDEV 2.4/1 - Classification of Medical Devices.

   Regardless of the classification result, all equipment must still comply with the fundamental principles of the Directive (essential health and safety requirements); comply with reporting requirements under the vigilance system and display the CE marking.

   Class I devices:

   Class I devices follow the self-declaration route, unless the device is sold as Class I tape sterilized (Is) or Class I tape measured (Im). This situation requires the participation of a notified body.

   Class IIa and IIb Devices:

   Class IIa and Class IIb devices require the services of a Notified Body to conduct a conformity assessment to approve a declaration of conformity.

   Class III devices:

   Class III devices represent the highest risk and generally require an assessment by an expert team of assessors from a Notified Body.

   Depending on the manufacturer's specific preferences and specific requirements, there are a number of different conformity assessment methods to choose from. The most common method is usually to choose Appendix II. Once you have a certificate issued by a notified body, you can CE mark the device and place it on the market. Most Member States will also require you to register your device with the relevant national authority.