Share on LinkedInShare on LinkedInShare on FacebookShare on FacebookTweet thisTweet this

Consumer Goods and Retail


Minimize menuMaximize menu

Minimize menuMaximize menuHomeConsumer Goods & RetailMedical DevicesTrainingGlobal Regulations98/79/EC – In Vitro Diagnostic Medical Device Directive – CE Marking for Europe

Related Links

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 recognized 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.

Email us
Medical DevicesBrochure Medical Devices: Find the Fastest and Most Reliable Route to Market Audits, Certification & Training ...
IVD Medical DevicesWhite PaperIVD Medical Devices White PaperAbout EC DIRECTIVE 98/79/EC-IVD Medical Devices
Medical DeviceRegulations White PaperMedical Device Regulations White PaperAbout MD market entry regulations in 13 main markets (PDF 2.55 MB)


SGS North America Inc.
Consumer and Retail

  • Suwanee Laboratory
    620 Old Peachtree Road - SUITE 100
    Suwanee, Georgia, 30024
    United States
  • t   +1 770 570 1800
  • f   +1 770 277 1240
  • e   Email us


Sign up to SGS publications and newsletters from your region and around the world.

Office Directory

Find SGS offices and labs around the world.USA map
Office Locator