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Consumer Goods and Retail In Vitro Diagnostic Devices Regulation (EU) 2017/746 – CE Marking Certification

Gain CE Marking certification against In Vitro Diagnostic Device Regulation (IVDR) (EU) 2017/746 with SGS.

Medical device

In Vitro Diagnostic Devices Regulation (EU) 2107/746 is a legal requirement for all manufacturers placing their products on the market. IVD medical device manufacturers of Class A sterile, Class B, Class C and Class D devices must obtain CE Marking certification against IVDR (EU) 2017/746 from a Notified Body before using the CE Mark and placing products on the market.

As a European Notified Body (0120 based in UK) under the In Vitro Diagnostic Devices Directive 98/79/EC (IVDD) with a wide-ranging scope designation, we can help you gain certification. The scope covers most products with only a few exceptions.

Read the full detailed scope >

Why choose IVDR CE Marking certification from SGS?

We can provide:

  • CE Marking certification against IVDR (EU) 2017/746, enabling you to use the CE Mark on your products
  • Effective and efficient IVDR certification – wherever your company or manufacturing is based – thanks to our global network of local offices.
  • Certification options under IVDR (EU) 2017/746, including Annex IX site audits and assessment of technical documentation

Learn more about how you can get CE marking for your IVD medical device >

Trusted IVDR CE Marking certification from a world-leading certification provider

Active participation in working groups set by the European Commission and Competent Authorities give us the latest compliance knowledge to meet your CE Marking certification requirements. We offer 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.

Our designation as a Notified Body under IVDR is pending.

Independence and impartiality

To comply with Medical Devices and In Vitro Diagnostic European Regulations (EU) 2017/745 & (EU) 2017/746, the management team of SGS Notified Body have signed Declaration of Interests.

We have also outlined our commitments in our Global Declaration of Integrity.

To find out more, contact us today.