Disposable top quality polypropylene gown 40 grams per m2. Hygiene gown with practical and reliable zip c…
Disposable white polypropylene gown of 30 gr / m2. Elasticated wrist sewn and closed with 4 snaps. Classi…
Charlotte with clips in non-woven white polypropylene. This charlotte has a heat-sealed latex-free elasti…
Disposable coverall in blue category III type 5 and 6 offering maximum comfort (high permeability to wate…
Weecover Max 1 from Weesafe is a special disposable asbestos coverall with flat-sealed seams for maximum …
It helps to ensure the protection of operators during treatment operations and protects agents from phyto…
Covered seams provide a seal against diluted particles, pesticides, and biological hazards in liquid or p…
Disposable coverall with ventilated back Weeback category III type 5 and 6. The ventilated back of the co…
3-layer non-woven SMS polypropylene suit: Spunbonded Meltblown Spunbonded. Elastic 3-piece hood. Two-way …
White clip model suitable for use in communities, catering, industry, laboratories, pharmaceutical indust…
Model offers double protection with a first zipper covered with a flap, and a second zipper also covered …
Disposable protection kit for work in the presence of asbestos. This kit is fully adapted to asbestos rem…
Disposable microporous SMS antistatic PP+PE gown with collar. This gown is category 1 personal protective…
Disposable visitor dung for insulation and to limit cross-contamination. Reinforced version with weight i…
Single-use round charlotte, white color. Charlotte in non-woven polypropylene with elastic sewn on the ed…
Disposable disposable gown of insulation in green polypropylene. Gown worn by nursing staff and visitors …
Our white disposable coverall in 40g polypropylene for professional work such as painting, risk-free clea…
Green clips suitable for use in communities, catering, industry, laboratories, pharmaceutical industries,…
White non-woven polypropylene laminated disposable coverall. Antistatic material. Soft, lightweight and f…
Round and white in color, it is made of polypropylene with a sewn and elasticated construction. It is eas…
Disposable disposable insulating gown in white polypropylene. Gown worn by nursing staff and visitors ove…
Disposable Charlotte blue clips suitable for use in communities, catering, industry, laboratory, pharmace…
White clip-on model made in France. Made from 100% polypropylene spunbonded non-woven fabric. Charlotte w…
Disposable white polypropylene cap with visor. Adapted to the HACCP method. Charlotte non-woven polypropy…
Latex-free synthetic elastic without hem for greater comfort for agents. White clip-on model made in Fran…
Features a latex-free heat-sealed elastic to prevent allergies. Clip-on model in blue polypropylene non-w…
Protecting heads with a disposable paper cap reduces the risk of hair falling into food preparations or p…
Blue visitor's blouse in non-woven polypropylene with back and neck strap closure. Packaged in a bag of 2…
Model with double "special comfort" elastic that ensures the user an excellent fit. Clip system is to be …
Usable in pharmaceutical, industrial, agri-food, medical environments... The assembly is carried out by u…
Visitor kit including a polyethylene blouse with hood and snap buttons, a cap, a paper mask, a pair of po…
Disposable disposable insulating gown in sky blue polypropylene. Gown worn by nursing staff and visitors …
Disposable chef's hat in extra white crepe paper. Openwork bottom that improves the breathability of the …
Can be used in pharmaceutical, industrial, food, medical environments, etc. Its great extensibility allow…
Universal disposable surgeon's cap in viscose for hospital and medical field. This disposable cap complie…
Blue clip-on model made in France. With latex-free synthetic elastic without hem for greater comfort for …
Polyethylene visitor coat with hood, 15 micron thickness. Length = 160 mm (with hood) / Width = 70 mm. Pr…
Disposable baby bib in white wadding / PE 24 gr/m2. Dimensions 250 x 345 mm. Small model. Very practical …
Disposable baby bib in white wadding / PE 45 gr/m2. Dimensions 420mm x 300mm Very practical to implement …
Universal disposable viscose surgeon cap for hospital and medical use. This disposable cap complies with …
Dunicel bib on the theme of the sea. This bib is ideal for seafood themed restaurants; Duni quality for m…
Waterproof insulation gown to protect healthcare professionals and patients from cross infection. Compli…
Disposable blue bib wadding / PE 35 gr / m2. Dimensions: 49x38 cm. Very practical, the bib is resistant t…
Disposable protection kit for work in the presence of asbestos. White SMS non-woven coverall. The kit con…
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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