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Medical devices certification can require certification against a combination of EC directives.

Medical device

In the event of multiple directives, CE marking can only be implemented by your organization when conformance is assessed against all the appropriate directives and harmonized standards.

SGS’s expert knowledge and our close links with medical devices authorities means we can offer you medical devices conformity assessment under 93/42/EEC, combined with the following EC Directives:

  • Personal Protective Equipment Directive 89/686/EEC
  • Non Automatic Weighing Instruments Directive 90/384/EEC
  • Machinery Directive 2006/42/EC
  • Pressure Equipment Directive 97/23/EEC
  • Radio and Telecommunications Terminal Equipment Directive 1999/5/EC

A combination of directives can appear complicated to the manufacturer and needs planning, so it is important to discuss your products and the certification options with our experts at the earliest opportunity.

The right combination of certification at the right time is the key to winning new contracts, launching new products and entering new markets. We work with you to plan activities, undertake audits and assessments, and deliver reports and certificates quickly – allowing you to enter markets sooner and with confidence.

It is our wide range of regulatory approvals, UK Accreditation Service (UKAS) accreditation and links with medical devices authorities that guarantee that you have chosen a certification partner that can meet your current and future requirements.

Undertake a medical devices conformity assessment with SGS to ensure your products can carry the CE mark.