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Joint assessments of notified bodies designated under the Medical Devices Directives
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Joint assessments of notified bodies designated under the Medical Devices Directives

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Medical devices include simple bandages right through to cardiac pacemakers, orthopaedic implants and sophisticated diagnostic equipment. Manufacturers have to produce devices meeting safety and performance requirements. In the EU, notified bodies are involved in the conformity assessment of many types of devices, particularly those classified as high risk to patients. For that purpose, notified bodies must meet 'designation criteria' demonstrating competence and independence. Since December 2013, the European Commission and Member States have been jointly assessing notified bodies to determine their fitness to function. This report describes the outcome of the assessments carried out until 31 January 2017. Joint assessments have been useful in harmonising the interpretation of designation criteria and raising notified bodies' performance, resulting in a 32% reduction in the number of notified bodies. With the publication of comprehensive new EU rules on devices, the Commission is confident that the progress already made in strengthening the functioning of the EU regulatory system will continue.
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ISBN 978-92-79-43524-9
DOI 10.2772/59119
Número de catálogo ND-BC-14-019-EN-N
ISBN 978-92-79-53340-2
DOI 10.2772/890492
Número de catálogo ND-BC-14-019-EN-C
PDF
ISSN ISBN 978-92-79-43524-9 DOI 10.2772/59119 Número de catálogo ND-BC-14-019-EN-N
Impreso
ISSN ISBN 978-92-79-53340-2 DOI 10.2772/890492 Número de catálogo ND-BC-14-019-EN-C
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