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Disposable white polypropylene gown of 30 gr / m2. Elasticated wrist sewn and closed with 4 snaps. Classi…
Disposable top quality polypropylene gown 40 grams per m2. Hygiene gown with practical and reliable zip c…
Charlotte with clips in non-woven white polypropylene. This charlotte has a heat-sealed latex-free elasti…
White non-woven polypropylene laminated disposable coverall. Antistatic material. Soft, lightweight and f…
White disposable clip-on charlotte suitable for use in communities, catering, industry, laboratories, pha…
Disposable coverall waterproof against pesticide and phytosanitary treatments. Weepro max green from Wees…
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Blue non-woven polypropylene clip-on cover. This charlotte has a latex-free heat-sealed elastic to preven…
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Cat III coverall type 4 5 6 Weepro Max plus is a disposable coverall with waterproof heat-sealed seams. C…
Weecover max 1 from Weesafe is a special disposable asbestos suit with flat heat-sealed seams for maximum…
Our white disposable coverall in 40g polypropylene for professional work such as painting, risk-free clea…
Disposable Charlotte green clips suitable for use in communities, catering, industry, laboratory, pharmac…
Charlotte clip color white made in France. Charlotte made from 100% polypropylene spunbonded non-woven fa…
The white round charlotte is made of polypropylene with a sewn and elasticated construction. It is easy t…
Since May 2021, European Directive 93/42 on medical devices has given way to Regulation (EU) 2017/745. common to all member states. • Reasons for a change The European Directive 93/42/EEC is a regulatory text drafted by the European Union, applied since 1993, giving common indications concerning the placing on the market of medical devices. This directive, applicable to all member states of the European Union, has been enriched by other directives for nearly 25 years. Each of these directives has been transposed into the legislation of each member state of the European Union. This thus leaves free rein to the interpretation of each member state, concerning the obligations of placing on the market of medical devices. In April 2017, the European Parliament voted to implement a new text aimed at unifying all medical device players under a single regulation, more comprehensive in line with the current technological context. This new regulation aims to improve traceability and transparency at European level, but also to be able to monitor notified bodies more closely. The regulation on medical devices came into force on 26 May 2017, and has been applied since 26 May 2021. This transition must be applied by companies but also by notified bodies.
The regulation modifies the scope of medical devices, significantly strengthens their evaluation criteria and procedures , as well as the responsibilities of the various actors. ? reinforced procedures: the regulation is no longer transposed into the health code of each country of the European Union but must be applied as is. This avoids disparities between the different notified bodies and Member States in terms of the requirements to be met. ? improved monitoring - EUDAMED: Among the notable changes, a new post-certification monitoring system is being implemented from May 26, 2021 in order to identify each medical device according to its own code called "UDI" (Unique Device Identification). All of this data is listed in the new European database called EUDAMED. This “serial number” specific to each medical device will allow very precise traceability. This new feature will be very useful during recalls of certain devices and in particular with the aim of assessing as quickly as possible the number of people affected by the incident. ? clinical evaluations: A more precise framework for clinical evaluations and investigations for MDs before they are placed on the market.
MDs are divided into four classes based on their risk level : - Class I Low risk level - Class IIa Medium degree of risk - Class IIb High risk potential - Class III Very serious risk potential The rules to be followed to determine the class of the MD are set out in Annex VIIII of Regulation 2017/745 and take into account the duration of use, the invasiveness or not and the type of invasiveness, the possibility or not of reuse, the therapeutic or diagnostic aim and the part of the body concerned. Non-sterile class I MDs or those not having a measuring function are self-certified by the manufacturer. For other devices; the intervention of a notified body is systematic for the CE certification process.
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