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98/79/EC – In Vitro Diagnostic Medical Device Directive – CE Marking for Europe

Ensure your in vitro diagnostic (IVD) devices are safe, legal and brought to market quickly with an SGS audit to achieve 98/79/EC certification and an IVD CE mark.

Directive 98/79/EC for in vitro diagnostic medical devices is a legal requirement for all manufacturers placing their products on the market in the EU, European Free Trade Area (EFTA), Switzerland, Turkey and some countries wishing to join the EU. This IVD directive is also a contractual requirement in some other regions of the world.

SGS UK is Notified Body 0120 under directive 98/79/EC. We have a full scope of designation under the directive, i.e. all List A, List B and Self-Test IVD devices. Our global network of local offices ensures that wherever your company or manufacturing is based, 98/79/EC certification can be achieved effectively and efficiently.

The certification options under this IVD directive include Annex III, IV and VII comprising site audits and assessment of technical documentation. Our site audits will usually assess compliance to both ISO 13485:2003 and directive 98/79/EC.

We have a network of specialist IVDD auditors in Europe, Asia and North and South America to support the active IVD sector. This allows us to audit you to help ensure you meet your regulatory obligations with recognised certification across the range of regulatory schemes that are essential for marketing products in global regions, including North America, the EU and Asia Pacific.

Support your entry to the European IVD market and CE marking with an audit against directive 98/79/EC from SGS.

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