Trade 93/42/EEC – Medical Devices Directive, CE Marking for Europe
Manufacturers of Class I (sterile/measuring), IIa, IIb and III devices must obtain certification against the CE marking directive, 93/42/EEC, from a Notified Body before using the CE mark and placing products on the market.
To enable your organization to achieve CE marking certification SGS is Notified Body 0120 under directive 93/42/EEC for all devices including drug device combinations and associated directives 2003/32/EC (animal tissue), 2005/50/EC (total joint implants) and 2007/47/EC (amendments). A successful audit from SGS will ensure your products’ compliance and 93/42/EEC certification.
Our global network of local offices ensures that wherever your company or manufacturing is based, 93/42/EEC certification can be achieved effectively and efficiently.
The certification options under this directive include Annex II, V and VI comprise site audits and assessment of technical documentation. Our site audits will usually assess compliance with both ISO 13485:2003 and directive 93/42/EEC.
United Kingdom Accreditation Service (UKAS) accreditation and close links with European Commission and Competent Authorities make us a natural partner to meeting your CE certification requirements. Partnering with SGS gives you access to expert knowledge, a global network of auditors and the opportunity to combine CE Marking with our wide range of other regulatory certification in one audit.
CE mark and sell your medical devices in Europe with 93/42/EEC certification from SGS UK.
The described training services, e. g. GAP analysis, are performed by the department “Training und Seminare” of SGS Germany GmbH.