However, the first major milestone – the introduction of an EU Database for Medical Devices (EUDAMED) – is on track to launch in 2020. Under the new EU MDR, medical devices cannot contain substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR 1A/1B) or endocrine-disrupting substances (EDS) in amounts over 0.1% w/w without justification. In the context of the MDR there is no separate definition under §2, but in Annex I there is an indirectly linked basic requirement: Aiming to provide higher levels of safety and transparency as well as restoring public confidence, in May 2017 the EU adopted the Medical Devices Regulation (MDR, 2017/745/EU), with a three-year transition period for compliance from manufacturers. MDR is valid for all EU member states. CMR Category 1A/1B Substances. As reliable information is provided by studies, classification and number of CMRs may change. Thus, when made final, they are intended to be used by manufacturers, notified bodies, and regulatory bodies. Reach out in case you need support. Even information or precautionary measures shall be given in the instructions for use for certain groups considered particularly vulnerable to such substances and/or materials. Assent helps medical device companies collect and manage their supply chain data in order to prepare them for the May 2021 deadline. EU MDR and Requirements Regarding Phthalates. The use of latex, as well as substances of human or animal origin, must also be declared if present. contrary to the MDD, the MDR clearly requires that the details of the EU Auth. By introducing new roles and responsibilities for all economic operators, the MDR now combines all necessary elements in a single legislation. CMR substances in Regulation (EU) 2017/776 [4], amending Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP Regulation) There are two effective dates in the new Regulation. Among others one special requirement rises for those products resp. CMR substances. New EU medical devices regulation (MDR) has been drawn up and it affects all products classed as medical devices to be sold in Europe. The entry 28, 29 and 30 of REACH annex XVII restricts the use of CMR category 1A and 1B substances in products supplied to the general public (i.e, cleaning products, paints) and requires additional labeling for products intended for professional users. This poster examines the specific criteria from EC 1272/2008 (CLP) and EC 1907/2006 (REACH) that will trigger label declaration and justification under EU MDR. Regulation (EU) No 528/2012 of the European Parliament and the Council ( 3 ), in accordance with the criteria that are relevant to human health amongst the criteria established therein. The phthalates widely used in the production process are of two types. Navigate MDR EASY MANAGE UDI AND EUDAMED. TECHNICAL DOCUMENTATION. 2. Little Pro on 2017-04-11 Views: Update:2019-11-16. Please see below for example or explanation for EU MDR Technical Documentation. These are: May 24, 2018 for formaldehyde ; The CLP Regulation ensures that the hazards presented by chemicals are clearly communicated to workers and consumers in the European Union through classification and labelling of chemicals. 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