MEDICAL DEVICE TESTING

Medical Devices are regulated by specific standards and regulations. Each country is applying its own regulation or directive.

Europe, with CE marking, applies Medical Device Regulation (EU) 2017/745 and its updated versions. European Commission of EU provides guidance documents to assist stakeholders in implementing directives related to medical devices. In USA, FDA is responsible for medical devices. CDRH (Center for Devices and Radiological Health) of FDA is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the USA. If you need further information about FDA medical device regulations click here. Canada applies its own regulation named as Medical Devices Regulations SOR/98-282.

Medical devices have to be tested according to Safety and EMC testing standards. Two of well known standards are IEC 60601-1 and IEC 60601-1-2.

Testups can assist you what EMC and Safety standards and collateral standards are required for certifying your product. After compliance according to relevant standards, you can sell your medical devices to international markets.

IEC 60601-1 contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Click here to see a preview consolidated version of IEC 60601-1 (Edition 3.1 2012-08).

IEC 60601-1-2 applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by me equipment and me systems. This collateral standard to IEC 60601-1 specifies general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances and for electromagnetic emissions of ME equipment and ME systems. IEC standards are not free of charge, you have to purchase standards from web stores. However, IEC allows to see a preview of the standards. See preview of IEC 60601-1-2 (Edition 4.0 2014-02). IEC 60601-1-2 has four main editions. Recent one is Edition 4.1 which is IEC 60601-1-2:2014+AMD1:2020. Before applying Medical EMC tests, you have to check whether IEC published a new edition. Learn more about IEC 60601-1-2. 

If you are selling to Europe, USA or Canada, EMC testing or certification of your medical device must comply with the 4th edition of IEC 60601-1-2 by 31 December 2018.

There are specific types of medical devices like ventilators (respirators). Such specific medical devices are tested according to relevant regulations and standards. Regulations for ventilators (respirators).

How to test wireless medical devices?
If a medical device has wireless communication function, additional tests has to be performed. For CE marking, wireless medical devices are also under Radio Equipment Directive (2014/53/EU). According to the frequency, relevant ETSI standard applied to wireless medical device. For FDA approval, Wireless Coexistence Testing shall be performed according to IEEE/ANSI C63.27.

How to validate software for FDA?
If a medical device has software you may need additional testing or validation for software. For this requirement, FDA published a guide. You can click on this link to read this 47-page guide: General Principles of Software Validation Testups, with its partners, offers software validation services.

Covid-19 and Medical Devices
During Covid-19 breakout medical devices are so essential for treatments. European Union published a guide headed Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context. On this 11-page guide, you can find the answers of below questions:

What is a medical device, active implantable medical device and an in vitro diagnostic medical device?

What are the legal requirements for placing such medical devices on the EU market and how should the compliance with them be verified and documented?

How can standards be used under the legislation?

Where can standards be obtained?

Due to the urgency caused by the COVID-19 outbreak, is there a
possibility to derogate from the normal conformity assessment procedures?

Is it necessary to register the devices?

How can I get in touch with the national competent authorities?

Off label use of a medical device

Will the new Regulations on medical devices and in vitro diagnostic medical devices replace the three current Directives?

You can also see Harmonised standards under 93/42/EEC – Medical Devices Directive with relevance to COVID-19 on this guide.

Certify your Medical Devices with Accredited Laboratories