Ppe regulation eu 2016425 guidelines 1st edition april. Council directive 89686eec of 21 december 1989 on the approximation of the laws of the member states relating to personal protective equipment this document comes with our free notification service, good for the life of the document. Conforms to category 2 personal protective equipment ppe directive 89686eec. Eu commission updates standards list for ppe directive. It can be described as covering any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards, and it is.
Interface with other directives medical devicesdirective89336eec relating to electromagnetic compatibility and directive 89686eec relating to personal protective equipment. Complete list of notified bodies for eu 89686eec personal protective equipment directive click to view the latest lists of notified bodies. Council directive of 21 december 1989 on the approximation of the laws of the member states relating to personal protective equipment 89 686 eec. It provides a cross reference from the legal text of the directive to explanations by eu sectorial. Ema first guidance on new rules for certain medical devices february 2019.
Ce marking ce mark for personal protective equipment. All regulatory documents shown below were published by the european parliament or european commission. Ppe guide to application of the ppe directive 89686eec. Direttiva 89686 sui dispositivi di protezione individuale. In deciding whether a product falls under directive 9342eec or under directive 89686eec, particular account shall be taken of the principle intended purpose of the product. Post market surveillance needs to include trend reporting.
Guidance document on the ppe transition from directive 89686. Surg0006 guide for class i manufacturers on compliance. New links added in may 2019 software as medical device samd. Directive of personal protective equipment ppe 90384 eec. Please help us maintain this list by reporting outdated or missing documents. We are continuously switching to new eu certificates for our product range. Richtlinie uber personliche schutzausrustung 89686eec bsi. The standards on this list may be used by personal protective equipment manufacturers to prove that their equipment complies with the essential requirements of this directive. For the relation between the mdd and directive 89686eec concerning. Guidance on the borderlines with in vitro diagnostic medical devices. The construction products directive council directive 89106eec council directive 89106eec of 21 december 1988 on the approximation of laws, regulations and administrative provisions of the member states relating to construction products 89106eec oj l 40, 11. Commission communication in the framework of the implementation of the council directive 89686eec of 21 december 1989 on the approximation of the laws of the member states relating to personal protective equipment publication of titles and references of harmonised standards under the directive.
Communication 2000 in framework of implementation of emc directive 89 336 eec 89 686 eec. Raccolta linee guida meddev dispositivi medici certifico srl. Guidance internal market, industry, entrepreneurship and. The regulation of medical devices facilitates the free circulation of these goods in europe and is intended especially to ensure that. A transition process has been outlined in article 47 of the regulation which states without prejudice to member states shall not impede the making available on the market of products covered by directive 89 686 eec which. Guideline for designating authorities to define the. L 39918 direttiva del consiglio del 21 dicembre 1989 concernente il ravvicinamento delle legislazioni degli stati membri relative ai dispositivi di protezione individuale 89686cee.
Interpretation of the relation between the revised directive 9342eec concerning medical devices and directive 89686eec on personal protective equipment. Mdd 9342eec article 1 scope of the medical devices. Ppe guidelines guide to application of the ppe directive 89686eec version 24. The report has been prepared to specify terms associated to common. Foetal distress or death, congenital abnormality, birth defects are required to be reported as incidentsaccidents. European medical devices directive 9342eec with 200747ec. Council directive 89 686 eec of 21 december 1989 on the approximation of the laws of the member states relating to personal protective equipment. Emergo group provides regulatory and quality assurance consulting for medical device companies. Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in council directive 89686eec and this directive, the relevant basic health and safety requirements of directive 89686eec comment. Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in council directive 89686eec and this directive, the relevant basic health and safety requirements of directive 89686eec shall also be fulfilled. For the relation between the mdd and directive 89686eec concerning personal protective equipment, please see the commission services interpretative document of 21 august 2009 28 kb meddev 2. Centc 257, this guidance uses the collective terms of the technical report centr 153 2 as a source of definition.
The personal protective equipment ppe directive 89686eec is a fundamental piece of european legislation relating to occupational safety throughout europe. Regulation eu 2016425 on personal protective equipment. The ppe directive 89 686 eec was repealed with effect from april 2018 and the ppe regulation eu 2016425 now applies. Complete list of notified bodies for eu 889 686 eec personal protective equipment directive. A transition process has been outlined in article 47 of the regulation which states without prejudice to member states shall not impede the making available on the market of products covered by directive 89686eec which. Here you will find archived documents of switched products.
Guidance document on the ppe transition from directive 89686eec to regulation eu 2016425. Directive of personal protective equipment ppe 90384eec. Borderlines with medical devices february 2014 612. The personal protective equipment ppe directive 89 686 eec is a fundamental piece of european legislation relating to occupational safety throughout europe. Council directive 89686eec on the approximation of the laws of the member states relating to personal protective equipment. Personal protective equipment directive 89686eec bsi. Council directive 9368eec of 22 july 1993 amending. Directive on personal protective equipment guide to application. The personal protective equipment ppe directive lays down the conditions governing its placing on the market and free movement within the community and the basic safety requirements which ppe must. Objective the aim of this regulation is to ensure common standards for personal protective equipment ppe in all member states in terms of protection of health and the. Guidance document on the ppe transition from directive 89 686 eec to regulation eu 2016425 faq document 393 kb. Council directive 89686eec of 21 december 1989 on the approximation of the laws of the member states relating to personal protective equipment. The ppe personal protection equipment directive 89686eec was adopted in 1989 by the european council, and over 20 years little has changed since then, which technology and manufacturing techniques have progressed significantly. Bs pd centr 15438 plastics piping systems guidance for coding of products and their intended uses.
Communication 2000 in framework of implementation of emc directive 89336eec 89686eec. Specialties include ce marking ce mark, iso 485 implementation, fda 510k submissions, good manufacturing practices gmp, iso 14971, cgmp consulting, fda us agent and. Complete list of notified bodies for eu 89 686 eec personal protective equipment directive click to view the latest lists of notified bodies. If you need help determining the regulatory requirements for your medical device in europe, you may be interested in our custom regulatory strategy reports for europe. Processed in an nebb certified iso class 4 cleanroom environment. For the relation between the mdd and directive 89686eec concerning personal protective equipment, please see the commission services interpretative document of 21 august 2009 32 kb meddev 2. Atex product certification directive 201434eu contact us. Guidance faq for transition from atex 949ec to new atex directive 201434eu. Medical devices that also protect the user, must simultaneously be assessed against the requirements of the personal protective equipment directive 89686eec.
Complete list of notified bodies for eu 889686eec personal protective equipment directive. However, the commission approved a transition period extended to 20th june 1995 whereby all types of ppe can continue to comply with national. Personal protective equipment internal market, industry. The ppe directive 89686eec was repealed with effect from april 2018 and the ppe regulation eu 2016425 now applies. Mds 7005 medical devices referencing the directive 89686eec on personal protective equipment ppe. The objective of these guidelines is to clarify certain matters and procedures referred to in directive 89686eec concerning personal protective equipment ppe. The new european ppe regulation 2016425 was listed in the official journal on 21 st april 2016, starting its twoyear transition period to replace the current directive 89686eec the scope of the regulation. Bioclean clearview sterile single use goggles, ansell vwr.
Eu 89686eec corr corrigendum to council directive on. Guidance documents on transitional provisions are available as a common approach of the ppe committee working group, mainly based on the blue guide on the implementation of eu product rules. Using emc software tools for real world printed circuit board designs. The information in these documents is in compliance with the previous directive 89686eec. Council directive 9368 eec of 22 july 1993 amending directives 87404eec simple pressure vessels, 88378eec safety of toys, 89106eec construction products, 89336eec electromagnetic compatibility, 89392eec machinery, 89686eec personal protective equipment, 90384eec nonautomatic weighing instruments, 90385eec active. Council directive 89686eec of 21 december 1989 on the approximation of the laws of the member states relating to personal protective equipment oj l 399 of 30 december 1989. Guidance document on the ppe transition from directive 89686eec to regulation eu 2016425 faq document 393 kb. Today, the european commission published an updated list of the european harmonized standards that pertain to the personal protective equipment directive 89686eec. Further guidance and information can be found on the european. Council directive of 21 december 1989 on the approximation of the laws of the member states relating to personal protective equipment 89686eec.