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 Brochure Medical Devices Brochure 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) ...
ELECTRO - MEDICALDEVICES SERVICE BROCHUREElectro Medical Devices in Trusted HandsFor an industry where timing is everything, SGS offers medical device manufacturers a globally integrated solution to get their new devices to market ...

Contact

SGS Headquarters

  • 1 Place des Alpes
    P.O. Box 2152
    Geneva, 1211
    Switzerland
  • t   +41 22 739 91 11
  • f   +41 22 739 98 86
  • 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.World map
Office Locator

News

events