Editing Biomedical engineering (section)

==Regulatory issues==
{{more citations needed section|date=August 2017}}
Regulatory issues have been constantly increased in the last decades to respond to the many incidents caused by devices to patients. For example, from 2008 to 2011, in US, there were 119 FDA recalls of medical devices classified as class I. According to U.S. Food and Drug Administration (FDA), [[Class I recall]] is associated to "a situation in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death"<ref>U.S. Food and Drug Administration, Medical & Radiation Emitting Device Recalls [https://web.archive.org/web/20060101035022/http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm] </ref>

Regardless of the country-specific legislation, the main regulatory objectives coincide worldwide.<ref name=":6">{{cite web|publisher = World Health Organization (WHO)|date = 2003|title = Medical Device Regulations: Global overview and guiding principles|url = http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf|access-date = 2013-09-13|archive-date = 2013-10-25|archive-url = https://web.archive.org/web/20131025014131/http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf|url-status = live}}</ref> For example, in the medical device regulations, a product must be 1), safe 2), effective and 3), applicable to all the manufactured devices.

A product is safe if patients, users, and third parties do not run unacceptable risks of physical hazards, such as injury or death, in its intended use. Protective measures must be introduced on devices that are hazardous to reduce residual risks at an acceptable level if compared with the benefit derived from the use of it.

A product is effective if it performs as specified by the manufacturer in the intended use. Proof of effectiveness is achieved through clinical evaluation, compliance to performance standards or demonstrations of substantial equivalence with an already marketed device.

The previous features have to be ensured for all the manufactured items of the medical device. This requires that a quality system shall be in place for all the relevant entities and processes that may impact safety and effectiveness over the whole medical device lifecycle.

The medical device engineering area is among the most heavily regulated fields of engineering, and practicing biomedical engineers must routinely consult and cooperate with regulatory law attorneys and other experts. The Food and Drug Administration (FDA) is the principal healthcare regulatory authority in the United States, having jurisdiction over medical ''devices, drugs, biologics, and combination'' products. The paramount objectives driving policy decisions by the FDA are safety and effectiveness of healthcare products that have to be assured through a quality system in place as specified under [[Title 21 of the Code of Federal Regulations|21 CFR 829 regulation]]. In addition, because biomedical engineers often develop devices and technologies for "consumer" use, such as physical therapy devices (which are also "medical" devices), these may also be governed in some respects by the [[Consumer Product Safety Commission]]. The greatest hurdles tend to be 510K "clearance" (typically for Class 2 devices) or pre-market "approval" (typically for drugs and class 3 devices).

In the European context, safety effectiveness and quality is ensured through the "Conformity Assessment" which is defined as "the method by which a manufacturer demonstrates that its device complies with the requirements of the European [[Medical Devices Directive|Medical Device Directive]]". The directive specifies different procedures according to the class of the device ranging from the simple Declaration of Conformity (Annex VII) for Class I devices to EC verification (Annex IV), Production quality assurance (Annex V), Product quality assurance (Annex VI) and Full quality assurance (Annex II). The Medical Device Directive specifies detailed procedures for Certification. In general terms, these procedures include tests and verifications that are to be contained in specific deliveries such as the risk management file, the technical file, and the quality system deliveries. The risk management file is the first deliverable that conditions the following design and manufacturing steps. The risk management stage shall drive the product so that product risks are reduced at an acceptable level with respect to the benefits expected for the patients for the use of the device. The [[technical file]] contains all the documentation data and records supporting medical device certification. FDA technical file has similar content although organized in a different structure. The Quality System deliverables usually include procedures that ensure quality throughout all product life cycles. The same standard (ISO EN 13485) is usually applied for quality management systems in the US and worldwide.

[[File:Hip replacement Image 3684-PH.jpg|thumb|right|Implants, such as [[artificial hip]] joints, are generally extensively regulated due to the invasive nature of such devices.]]

In the European Union, there are certifying entities named "[[Notified Body|Notified Bodies]]", accredited by the European Member States. The Notified Bodies must ensure the effectiveness of the certification process for all medical devices apart from the class I devices where a declaration of conformity produced by the manufacturer is sufficient for marketing. Once a product has passed all the steps required by the Medical Device Directive, the device is entitled to bear a [[CE marking]], indicating that the device is believed to be safe and effective when used as intended, and, therefore, it can be marketed within the European Union area.

The different regulatory arrangements sometimes result in particular technologies being developed first for either the U.S. or in Europe depending on the more favorable form of regulation. While nations often strive for substantive harmony to facilitate cross-national distribution, philosophical differences about the ''optimal extent'' of regulation can be a hindrance; more restrictive regulations seem appealing on an intuitive level, but critics decry the tradeoff cost in terms of slowing access to life-saving developments.

===RoHS II===
Directive 2011/65/EU, better known as RoHS 2 is a recast of legislation originally introduced in 2002. The original EU legislation "Restrictions of Certain Hazardous Substances in Electrical and Electronics Devices" (RoHS Directive 2002/95/EC) was replaced and superseded by 2011/65/EU published in July 2011 and commonly known as RoHS 2.
[[Restriction of Hazardous Substances Directive|RoHS]] seeks to limit the dangerous substances in circulation in electronics products, in particular toxins and heavy metals, which are subsequently released into the environment when such devices are recycled.

The scope of RoHS 2 is widened to include products previously excluded, such as medical devices and industrial equipment. In addition, manufacturers are now obliged to provide conformity risk assessments and test reports – or explain why they are lacking. For the first time, not only manufacturers but also importers and distributors share a responsibility to ensure Electrical and Electronic Equipment within the scope of RoHS complies with the hazardous substances limits and have a CE mark on their products.

===IEC 60601===
The new International Standard [[IEC 60601]] for home healthcare electro-medical devices defining the requirements for devices used in the home healthcare environment. IEC 60601-1-11 (2010) must now be incorporated into the design and verification of a wide range of home use and point of care medical devices along with other applicable standards in the IEC 60601 3rd edition series.

The mandatory date for implementation of the EN European version of the standard is June 1, 2013. The US FDA requires the use of the standard on June 30, 2013, while Health Canada recently extended the required date from June 2012 to April 2013. The North American agencies will only require these standards for new device submissions, while the EU will take the more severe approach of requiring all applicable devices being placed on the market to consider the home healthcare standard.

===AS/NZS 3551:2012===
[[Standards Australia|AS/ANS 3551:2012]] is the Australian and New Zealand standards for the management of medical devices. The standard specifies the procedures required to maintain a wide range of medical assets in a clinical setting (e.g. Hospital).<ref name="Standards Australia">{{cite book|url=http://infostore.saiglobal.com/store/details.aspx?ProductID=1595659|title=AS/NZS 3551:2012 Management programs for medical equipment|date=2016-10-18|publisher=Standards Australia|isbn=978-1-74342-277-9|access-date=2016-10-18|archive-date=2014-03-11|archive-url=https://web.archive.org/web/20140311084154/http://infostore.saiglobal.com/store/Details.aspx?productID=1595659|url-status=live}}</ref> The standards are based on the IEC 606101 standards.

The standard covers a wide range of medical equipment management elements including, procurement, acceptance testing, maintenance (electrical safety and preventive maintenance testing) and decommissioning.