Medical Devices

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MEDICAL DEVICES DIRECTIVE 93/42/EEC Inc Amendment M5

Background and Scope

The Medical Devices Directive (MDD) 93/42/EEC of 14 June 1993 applies to devices used in medicine and their accessories, including related software. The definition of a medical device includes:

  • Diagnostic and monitoring equipment for alleviation of disease, handicap or injury.
  • Equipment used to alleviate injury or handicap e g wheelchairs, splints, crutches, special footwear, artificial limbs, and patient hoists.
  • Equipment used in treatment of disease or injury e.g. hypodermics, inhalers, bandages, Contraceptive devices.

With effect from 14th June 1998, all medical devices and their accessories had to bear a legitimate CE mark.

Medical Devices which can also be classed as Machinery under Directive 2006/42/EC and personal protective Equipment under Directive 89/686/EC will also have to additionally meet the requirements of those Directives.

Software used in the device is classified as the same class as the device.

EC MEDDEVs. These documents are Guidance Notes in operating a Medical Device Management System for sales to and within the EU and provide additional information on issues such as vigilance. Although they are not legally binding, you are expected to follow them and would be issued with non-compliance's during an audit if you were not. it is anticipated they will become legally binding when the next version of the Directive is issued. Some link to the GHTF requirements (Global Harmonisation Task Force).

 

Competent Authority. Each European Government is required to appoint a Competent Authority to regulate the safety of Medical Devices. In the UK this is now the Medicines and Healthcare products Regulatory Agency (MHRA). It is the duty of a Competent Authority to ensure that the provisions of the Directive are correctly implemented. To assist companies, the MHRA provides an excellent set of Guidance Notes explaining the workings of the Medical Devices Directive in the UK. The Competent Authority registers the notified "Notified Bodies" under the Directive.

Notified Bodies. These are certification organisations, which carry out conformity assessment procedures. Under the Directive, Notified Bodies are responsible for any required assessment of Quality Systems, product testing and examination of documentation. Notified bodies are accredited to assess particular types of devices and it is important to choose a Notified Body which has the right scope. The Notified Body may subcontract testing to laboratories, but must retain the overall responsibility. The Quality System specifically designed for Medical Devices is EN ISO 13485:2012. For more information see ISO 13485.

Essential Requirements. The Medical Devices Directive lays down the Essential Requirements for Medical Devices. The essence of these requirements is that the device should be safe for the patient to use and should not hazard any other persons. The precise wording of Annex 1 of the Directive is fundamental to the application of the Directive.

European Norms (ENs). A list of standards, called ENs, that meet some or all of the Essential Requirements are published by the EC. It is important to be aware of all the ENs which apply to your product and to use them to meet the Essential Requirements.

 

Risk Management

Risk Management to EN ISO 14971:2012 is a requirement for all medical devices and In-vitro diagnostic devices. For further details see Risk Management or contact Atlantic Bridge Ltd.

 

Compliance

All medical devices must meet the Essential Requirements of the MDD. In addition there are different routes to compliance which cater for the differing hazards of the medical device.

In Annex IX of the MDD, Medical Devices are divided into 4 classes:

Class I, Class IIa, ClassIIb and Class 3. The Annex specifies how to determine the class. In general, Class I devices present the least hazard and Class 3 the greatest. For Class 1 Medical Devices a manufacturer or European Authorised Representative can declare conformity based on their own technical documentation (or Technical File) whereas all other Classes require the involvement of a Notified Body. For more information contact Atlantic Bridge Limited.