Compliance with the requirements of European Harmonised Standards is the most common means by which manufacturers of medical devices demonstrate compliance with one of the three medical device directives.
‘European Harmonised Standards’ are voluntary standards, covering both generic and technical subject matter, published by the European Standardization Organizations, CEN (Comité Européen de Normalisation) and CENELEC (Comité Européen de Normalisation Electrotechnique), in accordance with mandates from the European Commission.
A number of these Harmonised Standards are identical or very similar to international standards published by ISO (International Standardization Organisation) and IEC (International Electrotechnical Commission), thus achieving a large degree of harmonisation between Europe and the rest of the world. Two important standards for device compliance are EN ISO 13485:2012, ‘Medical devices, Quality management systems, Requirements for regulatory purposes’, and EN ISO 14971:2012, ‘Medical devices - Application of risk management to medical devices’.
A list of European Harmonised Standards is published from time-to-time by the European Commission – click here for the latest list.
GEMAR can help you identify relevant Harmonised Standards, and also how to demonstrate compliance with ERs when no relevant harmonised standards exist - contact us for further information.