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Gain CE Marking certification against Medical Device Regulation (MDR) (EU) 2017/745 with SGS.

Medical device

Medical device manufacturers of Class I (sterile/measuring/reusable), IIa, IIb and III devices must obtain CE Marking certification against MDR (EU) 2017/745 from a Notified Body before applying the CE Mark and placing products on the market.

As a Notified Body (0120 based in UK & 1639 based in Belgium) under Medical Devices Directive (93/42/EEC) with a wide-ranging scope designation, we can help you achieve CE Marking certification. The scope covers most products with a few exceptions, such as active implantable devices. A successful audit will ensure your products’ compliance and MDR (EU) 2017/745 certification.

Read the full detailed scope >

Why choose MDR EU 2017/745 CE Marking certification from SGS?

We provide:

  • CE Marking certification against MDR (EU) 2017/745, enabling you to use the CE Mark on your products
  • Effective and efficient certification – wherever your company or manufacturing is based – thanks to our global network of local offices
  • Certification options under MDR (EU) 2017/745, including Annex IX and XI-part A site audits and assessment of technical documentation

Learn more about how you can get CE Marking on your medical device >

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 MDR is pending.

Independence and impartiality

To comply with Medical Devices and In Vitro Diagnostic European Regulations (EU) 2017/745 and (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 use the CE Mark and sell your medical devices in Europe with MDR (EU) 2017/745 certification, contact us today.