Market placing medical device

Registration of Persons Responsible for Placing Medical Devices on the EU Market... 

As described previously, persons responsible for placing medical devices on the EU market are only required to notify the Competent Authority in the state where... 

It is not known what quality checks were in place with the device, or what tests had been performed before introduction to the market. The facts suggest weaknesses in product design and manufacture," a conclusion supported by evidence from the largest market for medical devices, the USA. 

The pressure equipment directive was adopted by the European Parliament and the European Council in May 1997. It harmonises the national laws of the 15 Member States of the European Union relating to equipment subject to the pressure risk. That directive is one of the series of technical harmonisation directives such as for machinery, medical devices, simple pressure vessels, gas appliances and so on, which were foreseen by the Communities programme for the elimination of technical barriers to trade. It therefore aims to ensure the free placing on the market and putting into service of the equipment concerned within the European Union and the European Economic Area. At the same time it permits a flexible regulatory environment, allowing European industry to develop new techniques increasing thereby its international competitiveness. 

AH medical devices marketed before May 28, 1976, are distinguished from devices developed after this date, ie, pre-1976 devices were grandfathered. Pre-1976 devices, and those devices similar to them are placed into one of three categories based on the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. 

The FDA of the U.S. Department of Health and Human Services (DHHS) administers the regulatory controls for the Food, Drug, and Cosmetic Act of 1906 and the 1976 and 1990 amendments, which provide approval for commercial distribution of safe and effective medical devices. The 1976 amendments directed the FDA to regulate medical devices under control levels that are necessary to ensure safety and effectiveness. In order to achieve this task, the Medical Device Law under the amendments required the FDA to issue regulations placing all medical devices on the market at that time into one of three regulatory classes ... 

A non-EEA manufacturer may place a Class I or custom-made medical device or a system or procedure pack on the EU market under their... 

Under section 515 of the act, all devices placed into Class III are subject to premarket approval requirements. Premarket approval is the process of scientific and regulatory review to ensure the safety and effectiveness of Class III devices. An approved PMA is, in effect, a private license (some would say a regulatory patent) granted to the applicant for marketing a particular medical device. A Class III device that fails to meet PMA requirements is considered to be adulterated under section 501 (f) of the act and cannot be marketed. Premarket approval requirements apply differently to preamendment devices, postamendment devices, and transitional Class III devices. 

No system is error free and detecting system faults during live operation is an entirely predictable event. Healthcare organisations therefore need to ensnre that the necessary processes are in place to support users when a fault is detected. Similarly, manufacturers need the infrastructure to respond to reported faults, prioritise them accordingly and institute a resolution. It is in this prioritisation phase where CRM plays an important role. Standards such as the UK s ISB 0129/0160 specifically require organisations to undertake CRM activities on reported faults [1, 2] and Medical Device manufacturers are likewise obligated to carry out post-marketing surveillance on their products. 

CE Mark. All medical textiles regarded as medical devices now placed on the market have to comply with the European Medical Devices Directive and bear the CE mark, demonstrating that they are fit for their intended purpose and meet the essential requirements of the Directive. If they are supplied sterile, then the manufacturer or suppher also needs to consult with a Notified Body. ... 

Directive 93/42/EEC, which covers the placing on the market and putting into service of medical devices... 

A sponsor may seek clearance for a device by fiHng a 510(k) premarket notification with the FDA, which demonstrates that the device is substantially equivalent to a device that has been legally marketed or was marketed before May 28,1976, the enactment date of the Medical Device amendments to the FD C act. The sponsor may not place the device into commercial distribution in the United States until the FDA issues a substantial equivalence determination notice. This notice may be issued within 90 days of submission but usually takes longer. The FDA, however, may determine that the proposed device is not substantially equivalent, or require further information such as additional test data or clinical data, or require a sponsor to modify its product labehng, before it will make a finding of substantial equivalence. 

Governments around the world approve the sale of medical devices in many different ways. In Australia the Therapeutic Goods Administration issues an Australian Register of Therapeutic Goods number to devices cleared for the market. In Canada a device licence is awarded by the Therapeutic Products Directorate. In the European Union, after receiving an EC certificate from a notified body, the manufacturer places the CE mark on the device. In Japan a shounin is issued by the Pharmaceutical and Medical Safety Bureau of the Ministry of Health, Labor and Welfare. In the United States the manufacturer of the device receives a marketing clearance (510(k)) or an approval letter (PM A) from the FDA. 

Multi-application equipment such as laser printers and identifieation cameras, whieh may be used in combination with medical devices, are not medical devices unless their manufacturer places them on the market with speeifie intended purpose as medical devices. 

European Parliament (2007) Medical devices directives Directive 2007/47/EC of the EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market... 

Biochip-based HIV tests have been developed by researchers at the University of Texas and Harvard Medical SchooF. The chip is placed into a toaster-sized analyser that counts the number of CD4+ cells in the drop of blood. Results are available in ten minutes and correlate well with flow cytometry (the gold standard). The device, which is being marketed by LabNow, Inc. weighs less than 2.3 kg, requires no excess reagents and is battery-operated. 

---