Eurofins E&E offers a range of testing and certifications services to help you get your medical devices to market on-time and on budget. Our international network of accredited electrical and electronics (E&E) laboratories and certification bodies offer a comprehensive range of testing and certification services for active and non-active medical devices and In Vitro Diagnostic Medical Devices (IVDs). Our experience and expertise provide you with the confidence to design, develop and deliver tested and certified products to your chosen markets, efficiently and cost-effectively.
Meet the demands of global markets
The market for medical devices is global and in all important markets, regulatory requirements are in place to ensure that products meet the highest standards and that they do not present a risk to patients or users alike. Unfortunately, these regulatory requirements and the methods of approval differ between countries and only in a few cases are these mutually recognised. For example, products must comply with EU Directives in the European Economic Area, the FDA's requirements in the United States, Health Canada's requirements in Canada, JPAL regulations in Japan and TGA requirements in Australia. In addition to these markets, many important countries globally have their own regulatory systems for medical devices and managing these requirements complex and time-consuming. Eurofins E&E provides you with a single point of contact for the testing and certification of your medical devices, allowing you to access your chosen markets, quickly, easily and cost- effectively.
Conformity assessment for EU markets
Our network of accredited laboratories and certification bodies offer a comprehensive range of testing and certification services for both active and non-active medical devices and in vitro diagnostic medical devices in line with the requirements of the MDD (medical device directive), MDR (medical device regulation) and the IVDD (in vitro diagnostic devices directive) for EU markets.
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
Certification for the US & Canada
To access the United States (US) and Canadian markets, medical devices or equipment needs to be certified. For the US, this should be undertaken by a Nationally Recognised Testing Laboratory (NRTL) and for Canada, a Standards Council of Canadian (SCC) Certification Body. Eurofins E&E North America is both an NRTL recognised by OSHA and a Certification Body accredited by the SCC and can provide the MET NRTL mark to demonstrate compliance with these requirements.