Email this pageEmail this pagePrint this pagePrint this page
Share on LinkedInShare on LinkedInShare on FacebookShare on FacebookTweet thisTweet this

Life Sciences

Categories

Minimize menuMaximize menu

Minimize menuMaximize menuHomeLife SciencesMedical DevicesAudit, Certification & VerificationCertificationOther EC Directives

Related Services & Resources

Other EC Directives

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

Email Us
Medical Devices ServicesBrochureMedical Devices Services brochureFind the most reliable route to the market (PDF 175KB) ...
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) ...
Electro-Medical DevicesBrochureComplete Global Solutions for Electro-Medical DevicesGet your product to market faster. We know the way. ...

Contact

SGS North America Inc.

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

E-SUBSCRIPTIONS

Sign up to SGS publications and newsletters from your region and around the world
STAY UP TO DATE.SUBSCRIBE NOW

Office Directory

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

News