EN ISO 14971:2009 RISK MANAGEMENT FOR MEDICAL DEVICES - INTRODUCTION
Directive. – The Medical Devices Directive 93/42/EEC has been amended many times. The latest, and most significant, amendment is applicable from 21 March 2010 and was issued under EC Directive 2007/47/EC.
This amendment introduced a host of changes, the most significant being:
- Medical Machinery having to comply with applicable Machinery Essential Requirements to the extent that these are more specific than the Essential Requirements of the Medical Devices Directive. This applies to devices as diverse as MRI scanners, riser recliner chairs and invalid scooters. Compliance does not require the D of C to refer to the Machinery Directive as the amended Medical Devices Directive is deemed to include these machinery requirements.
- Medical Devices incorporating Medicinal Products. The requirement for incorporated Medicinal products to be assessed to 2001/83/EEC.
- Procedure Packs. Requirements for compatibility of contents, supply of information and the internal controls and inspection when putting procedure packs together.
- Authorized Representatives. For those manufacturers outside the EC, a specific reference to the requirement for appointing a single authorised representative in Europe.
- Clinical Evaluation. The introduction of the requirement for a Clinical Evaluation. This clinical evaluation should cover effectiveness, side-effects and the acceptability of the benefit/risk ratio. It applies to all medical devices. The detailed requirements are in Annex X. Compliance must be documented in the "Technical File" for the device.
Risk. Medical Devices often involve balancing benefit against risk. The Medical Device Directive refers to this in Annex I the Essential Requirements as follows:
“… provided any risks which may be associated with their use constitute acceptable risks when weighed against any benefits to the patient and are compatible with a high level of protection of health and safety.”
The manufacturer is required to:
- Eliminate or reduce risks as far as possible.
- Take adequate protection measures.
- Inform users of residual risks.
In that order.
EN ISO 14971:2009 – risk management for medical devices is the all embracing standard, covering risk analysis, evaluation, control and post production information. The main body of this standard is identical to the 2007 version, only the annexes in the front have changed.
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