Medical Device Testing | Performance Testing

Eurofins Electrical and Electronic UK Ltd

Wolverhampton, United Kingdom

Eurofins E E offers a range of testing and certification services to help you get your medical devices to market on time and within 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 give you with the confidence to design, develop and deliver tested and certified products to your chosen markets efficiently and cost-effectively. Our core services include: Global Market Access - Medical Device Testing - Product Safety Testing - EMC Testing - Radio/Wireless Testing - Mechanical Climatic Simulations - Performance Testing Medical Device Certification - Notified Body Services for the EU - Approved Body Services for the UK - North American Certification Services Quality Management Systems Audits 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 do not present a risk to patients or users alike. These regulatory requirements and approval methods 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 requirements of the MHRA in the UK, 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 is complex and time-consuming. Eurofins E E provides 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. Medical Device Certification CE Marking Conformity assessment for EU Markets In Europe, the use of a Notified Body (NB) is required in the approval or certification process for medical devices. Our network of accredited laboratories and certification bodies offers 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 MDR (Medical Device Regulation) 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) that can provide conformity assessment to the Medical Device Regulation (MDR) 2017/745. 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. In-Vitro Diagnostic Regulation (IVDR) 2017/746 Our certification body in Finland (NB No. 0537) is a Notified Body under the In-Vitro Diagnostic Regulation (IVDR) 2017/746. UKCA Marking Conformity assessment for the UK Medical Devices placed onto the UK market will need to be UKCA marked and have been subject to Conformity Assessment by a UK Approved Body for Medical Devices. UKCA Designation for Medical Devices is currently underway for Eurofins E E CML Ltd UKAS No. 8175. For more information, talk to our team or contact our UK Medical Device Certification Team via EEinfoUK@eurofins.com Certification for the US Canada To access the United States (US) and Canadian markets, medical devices or equipment need to be certified to the specific requirements of those markets. 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 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 can help you navigate the FDA submission process. Eurofins 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). CB Scheme Our Certification Bodies in Germany, Switzerland and the United States are National Certification Bodies (NCB), and the test laboratories are Certification Body Testing Laboratories (CBTL) under the international certification body scheme (CB Scheme).