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Compliance for Class I Medical Device

1 December 2014

Compliance for Class I Medical Device (93/42/EEC)

When a medical device has been classified as Class I, it is defined as a low risk device and non-invasive. Typically these would be devices which, in whole or in part, do not penetrate the body, either through orifice or through the surface of the body

Essential requirements – Supplier registration

For a Class I medical device (and custom made devices, devices for clinical investigation and procedure packs) the Manufacturer must be registered with the Competent Authority in the Member State where they are resident.  In the UK, the Competent Authority is the Medicines and Healthcare Regulatory Agency (MHRA). The MHRA is also the enforcement body.

Safety Requirements

Annex 1 of the Medical Device Directive lays down a series of essential requirements for the design and construction of medical devices. The Essential Requirements of the Directive apply to all medical devices:

  • a general requirement for safe design
  • the minimisation of risks from contamination
  • compatibility with materials with which they are likely to come into contact
  • the minimisation of hazards of infection and microbial contamination
  • provision of sufficient accuracy (for devices with a measuring function)
  • protection against radiation
  • adequate product marking
  • adequate user instructions

Administrative requirements

In addition to Registration, manufacturers must typically

  • comply with the relevant essential requirements of annex 1 of the Directive
  • demonstrate design verification
  • carry out a risk assessment
  • demonstrate clinical evidence of the effectiveness of the device
  • implement a procedure for post market surveillance
  • complete a Declaration of Conformity
  • maintain a file of technical information about the product
  • Put the CE mark on the product (or its packaging)

Assessment

For a Class 1 medical device, the assessment is likely to be an approval of the type of device, and an audit of the quality systems and manufacturing processes.

CE marking

For devices that fall under the Medical Device Directive that are classified as Class I devices, the CE Marking (Directive 93/68/EEC) is required. Once a device bears the properly affixed CE Marking and has met all compliance requirements, it can be placed in the EU and allowed free movement between all member states.

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