Certification for Medical Devices

Medical Device Certification, Quality Management Systems & Audits

Notified Body Services for the EU

In Europe, the use of a Notified Body (NB) is required in the approval or certification process for medical devices. To assist you in placing your medical devices onto the EU market, Eurofins E&E has a number of Notified Bodies (NB) who can provide conformity assessment to:

• Medical Device Regulation 2017/745
• Medical Device Directive 93/42/EEC
• IVD Directive 98/79/EC

Medical Device Regulation (MDR) 2017/745

Our certification bodies in Finland (NB No. 0537) and Italy (NB No. 0477) are Notified Bodies under the MDR (2017/745) for both active and non-active medical devices.

Medical Device Directive (MDD) 93/42/EEC

Our certification bodies in Finland (NB No. 0537), Germany (NB No. 0681) and Italy (NB No. 0477) are Notified Bodies under directive 93/42/EEC for both active and non-active medical devices.

In Vitro Diagnostic Devices to the IVD Directive (98/79/EC)

For in vitro diagnostic medical devices, our certification body in Finland is a Notified Body (NB No. 0537) under the IVD Directive (97/79/EC).

North American Services

For the North American markets, an NRTL mark demonstrates compliance with the required standards for workplace safety which include hospitals, clinics, therapy centres and similar facilities.

Eurofins E&E North America is both an NRTL recognised by OSHA and an SCC Certification Body and can provide the MET NRTL mark to demonstrate compliance with the requirements of both of these bodies for medical devices.

The Eurofins MET-certified products certification mark is universally accepted in both the US and Canada for medical equipment.

FDA Submissions

All medical devices in the United States are regulated by the Food and Drug Administration (FDA) under the Center for Devices and Radiological Health (CDRH).

If you are introducing a new device to the US market, Eurofins E&E can help you navigate the FDA submission process.

We can also offer expert services to help you gain FDA approval covering Pre-Sub (formerly called Pre-IDE), US FDA 510(k) Premarket Notification submission, “De Novo” and Premarket Approval (PMA).

Quality Management Systems & Audits

ISO 13485 Quality Management System (QMS)

The global standard ISO 13485 stipulates the quality management requirements for regulatory purposes for medical device manufacturers and is the certified quality management system that 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 Electric & Electronics Finland Oy, No. S021
• Germany - Eurofins Product Service GmbH, D-ZM-12092-01-00
• Italy - Eurofins Product Testing Italy s.r.l., No. 133A

Medical Device Single Audit Program (MDSAP)

Our certification body in Finland acts in cooperation with an MDSAP recognised auditing organization, DQS Medizinprodukte GmbH, and can provide your organisation with MDSAP certification.

Please note that this service is only available in conjunction with the Notified Body services provided by Eurofins Electric & Electronics Finland Oy in Finland (NB No. 0537).

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