This directive, along with two associated directives, the Active Implantable Medical Devices Directive and the In Vitro Diagnostic Devices Directive, cover all medical equipment. 2007/47/EC also amends these directives.

The changes introduced by the amendment include:

• Specific inclusion of stand alone software in the definition of a medical device

• All devices, including Class I devices, need evidence of clinical efficacy

• Devices that contain a medicine such that it forms a single integral product intended exclusively for use in the given combination and which is not reusable are excluded from the MDD and covered by the Medicines Directive 2001/83/EC.

• Medical devices that are also machines as defined by the Machinery Directive (2006/42/EC) will generally need to be assessed against the essential health & safety requirements of that directive. (See below).

• Medical devices that also protect the operator/user must be assessed against the essential requirements of the Personal Protective Equipment Directive 89/686/EEC (link to PPE page).

• Custom made devices also will be subject to post market surveillance, and the particular patient for whom the device has been made must be supplied with certain information.

• If the manufacturer is based outside of the EU, he must appoint an Authorised Representative to act on his behalf.

• Post market surveillance activities are extended to include trend reporting.

• Foetal distress and death, congenital abnormality and birth defects are added to the list of incidents that mandate reporting to the MHRA.

• Single use devices must be accompanied with information on characteristics and technical factors known to pose a risk if the device were re-used.

• The Instructions for Use and the Declaration of Conformity must be controlled documents within the manufacturer’s quality management system.

• The quality management system must include procedures describing post market surveillance activities associated with the device.

• For the majority of devices the quality management system must include procedures describing the risk assessment associated with the device.

• Additional requirements for custom made devices and devices intended for clinical investigation relating to the use of animal tissues and human blood derivatives.

• Pre-clinical evaluation data must be included in the technical file.

• Third Party subcontractors will be more closely monitored by the notified body.

• Device classifications are sometimes changed, and you should keep up to date. Recently disinfectants for invasive devices have been reclassified from IIa to IIb.

• Harmonised standards are being continuously updated and new designs should comply with the most up to date standard where possible.

Further requirements for medical devices that are also machines:

Medical devices that are also machines as defined in the Machinery Directive will have to be assessed to the Essential Health & Safety Requirements of that directive in so far as they are more specific than the Essential Requirements of 2007/47/EC. The Essential Requirements of 2007/47/EC are not very specific so that in most cases manufacturer’s risk assessments must address the Essential Health & Safety Requirements of the Machinery Directive. They will not however claim compliance with that directive.

Where Particular Standards for medical device machines have been produced with the amendment in mind and become harmonised, compliance with the standard will mean that the MD ESHR’s have been addressed.

When the standards have not been updated, or for devices with no Particular Standard, evidence of meeting the MD ESHR must be provided. See Annex I of the Machinery Directive 2006/42/EC.