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Industries >> Medical Devices >> Medical Device Certification Services

Medical Device Certification Services

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Medical Device Market Access

Our international network of accredited electrical and electronics (E&E) laboratories and certifications bodies offer a comprehensive range of testing and certification services for active and non-active medical devices and In Vitro Diagnostic Medical Devices (IVDs) for gaining market access. Conformity assessment with the Medical Device Directive 93/42/EEC and IVD Directive 98/79/EC is offered by our Notified Bodies in Europe.

Placing medical devices onto your choice of global markets is costly and time consuming due to national and international variations in the approvals process. Our extensive expertise means that we have the experience to help our clients gain market access in the most efficient manner.

Eurofins E&E's Medical Device and Medical Electrical Equipment regulatory compliance services can all be accessed by contacting your local Eurofins E&E laboratory.

CB Scheme

The CB scheme of the IECEE has more than 50 participating countries which can be accessed using one test report and one CB test certificate, simplifying the process and accelerating your global market approvals process.

A number of our E&E Medical Device competence centers are National Certification Bodies (NCB) under the international certification body scheme (CB Scheme) for Medical Electrical Devices, and additional members of our laboratory network are Certification Body Testing Laboratories (CBTL).

ISO 13485 Quality Management System (QMS)

Global Standard ISO 13485 stipulates the quality management requirements for regulatory purposes for medical device manufacturers and is the certified quality management system which is most broadly recognised in the medical sector. Eurofins E&E has three ISO 13485 QMS Certification Bodies to assist in your compliance process:

  • Finland; Eurofins Expert Services, No. S021
  • Germany; Eurofins Product Testing GmbH, D-ZM-12092-01-00
  • Italy; Eurofins Product Testing Italy s.r.l., No. 133A

Note: ISO 13485:2016 superseded ISO 13485:2003/Cor 1:2009 and has a number of changes; the transition period ended on 1st March 2019.

Notified Body (NB) Services

Active & non-active Medical Devices

In order to legally sell products in the EU market, medical device manufacturers must earn a CE mark to confirm compliance with the Medical Device Directive 93/42/EEC. Medical devices are classified according to potential risks associated (Class I, II and III products).

Eurofins E&E has a three Notified Bodies under Directive 93/42/EEC, covering active and non-active Medical Devices:

  • Finland; Eurofins Expert Services, Notified Body No. 0537
  • Germany; Eurofins Product Service GmbH, Notified Body No. 0681
  • Italy; Eurofins Product Testing Italy s.r.l., Notified Body No. 0477

The Notified Bodies provide conformity assessment services to manufacturers in order to verify products compliance to applicable EU Directives. Conformity assessment procedures carried out by our experts in compliance with Directive 93/42/EEC (and its updates) help you to obtain the following:

  • Annex III; EC Type Examination certificates
  • Annex IV; EC Verification certificates
  • Annex V; Production quality assurance EC declaration of conformity
  • Annex VI; Product quality assurance EC declaration of conformity
  • Annex II; Full quality assurance system EC declaration of conformity

In vitro diagnostic medical devices

Eurofins E&E has a Notified Body for in vitro diagnostic medical devices in Finland, NB No. 0537, under Directive 98/79/EC to help you obtain the following:

  • Annex III; Ch 6 EC Design Examination certificate
    • IVD devices for self-testing
    • Annex II list A dvices
  • Annex IV; EC Quality system certificate
    • Annex II list A devices
    • Annex II list B devices
    • IVD devices for self-testing

For a list of medical products Eurofins' Certification Bodies cover, view our medical testing services.

for a complete scope of devices covered by Eurofins' Notified Bodies visit the European Commission website NANDO.

US and Canada

Eurofins MET-certified medical products

Eurofins MET laboratories is both an NRTL (Nationally Recognized Testing Laboratory) recognized by OSHA (Occupational Safety and Health Administration of US) for medical equipment, and an SCC (Standards Council of Canada) Certification Body.

We can therefore test and Eurofins MET-certify your medical electrical device for universal acceptance onto both the US and Canadian markets through a single testing and certification process.

FDA approvals

To complete the approval process in the US, we also offer expert services to help you gain FDA (Food and Drug Administration) approval covering: pre-submission; formal submission of 510(k), De Novo and PMA devices.

Contact your local Eurofins E&E laboratory or Eurofins MET labs to find out more about their medical device testing & certification.

Global Market Access

Our global network of Eurofins E&E Medical testing and certification experts offers a custom Global Market Access service for Medical Devices. Drawing upon the services described above, and our knowledge of regional and national technical requirements and approvals processes, we can give you a tailor-made testing, certification and approvals service for your medical devices' target market(s).

Market access services in addition to those already mentioned include, but are not limited to Australia, New Zealand, Japan and Brazil.

MDSAP

Eurofins Expert Services Oy, Finland, offers global Medical Devices Single Audit Program (MDSAP) certification in cooperation with an Auditing Organisation (AO) recognized in the MDSAP program.

 

Contact your local Eurofins E&E laboratory for more information on our medical device certification services.

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