The SVHC Candidate List now contains 211 substances. Rule 9 (active devices), more will be class III in the future. MDR (EU 2017/745) and IVDR (EU 2017/746) cover only Human Health SVHC based on human health hazards are exempted from authorisation requirements Environmental hazards still fall under the scope of REACH SVHC based on environmental hazards are not exempted from authorisation requirements (e.g. Regulation (EU) No 207/2011: entries 44 and 53 have been are deleted (substances severely restricted under Regulation (EU) No 850/2004 – substances as persistent organic pollutants). As part of our series of blog posts covering the implementation of the EU Medical Devices Regulation (MDR), we comment below on the latest developments, including the deferred application of the MDR and the most recent guidance issued by the European Commission’s medical device coordination group (MDCG).. List of groups of products without an intended medical purpose XVI 174 Correlation table showing: • Council Directive 90/385/EEC • Council Directive 93/42/EEC • The MDR XVII 175-176 MDR TRAINING On-Site and Public Courses MDR CONSULTING orielstat.com Gap Analysis, CER, Risk, 13485 RoHS – Restriction of Hazardous Substances; EU Authorized Representative. Rule 8 (class IIb implants), more will be class III in the future. Reminder: Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply. Please refer to Swiss Chemical Risk Reduction Ordinance (ORRChem) for more info. In the EU MDR, new stakeholders have been identified in the lifecycle of the medical device (in addition to the manufacturer), and the obligations for them have been defined in detail: authorised representative (Art. PBT; vPvB, endocrine disrupting properties) Regulation (EU) 2017/745 on medical devices will apply from 26 May 2021, Regulation (EU) 2017/746 on in vitro diagnostic medical devices from 26 May 2022. Exploring the Intersection of REACH, CLP and EU MDR Joshua Nevels, D.C. (Arcadis, U.S., Inc.) Abstract Since the promulgation of the new EU Medical Device Regulation (MDR) in May 2017, medical device manufacturers have been preparing for the upcoming mandatory compliance date of May 2020, after which significant new labeling for devices 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. Know that being in compliance with EU REACH regulation may not be enough, as MDR’s substances list of concern is more extensive. We have taken the official MDR regulation as published on May 5, 2017 and added a very easy-to-navigate clickable MDR Table of Contents – all in one single PDF. EU-OSHA – European Agency for Safety and Health at Work, Expert forecast on emerging chemical risks related to occupational safety and health, European Risk Observatory Report, 2009. You need to reach out to your suppliers and collect their disclosures of MDR-relevant substances present in the products. About the Medical Devices Regulation (EU) 2017/745; Major Aspects of the MDR; IVDR Economic operators incur added responsibilities and are subject to greatly increased scrutiny. Two substances were added to the EU REACH Substances of Very High Concern (SVHC) Candidate List today, taking immediate effect. Latest Updates of Endocrine Disruptors Regulations and Lists in EU. com Wed, 23 Dec 2020 New Croatian notified body designated to European MDR - Mass Device Tue, 22 Dec 2020 Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: The Binding Thread Of Risk Management - Med Device Online Mon, 21 Dec 2020 Notified. COVID Era … Deferral of the MDR. European Authorized Representation for Manufacturers of Medical Devices; EU Authorized Representative Responsibilities; EU Authorized Representative vs. These criteria relate to tax transparency, fair taxation, the implementation of OECD BEPS measures and substance requirements for zero-tax countries. Rules 19–22 are new to EU MDR, while rules 1–18 were carried over from the previous MDD. This means the manufacturers must demonstrate conformity with the general safety and performance requirements and other legal requirements, such as those relating to quality and risk management, laid down in this Regulation. The new regulations introduce new roles and responsibilities for EMA and national competent authorities (NCAs) in relation to certain types of medical devices and in-vitro diagnostics. The substances referenced in section 10.4.1 refer to regulatory substance lists that are typically updated every six months. www.medtecheurope.org Page 2 of 37 Introduction Provisions on CMR (carcinogenic, mutagenic, reprotoxic) and ED (endocrine disrupting) substances can be found in Annex I (‘General safety and performance requirements’) of the Medical Devices Regulation (MDR)1, in Chapter II (‘Requirements regarding design and manufacture’) and Chapter III (‘Requirements regarding The list is managed by the BOMcheck Substance List Regulation (EU) No 126/2013: entry 42 has been deleted (substances severely restricted under Regulation (EU) No 519/2012 amending Regulation (EC) No 850/2004 – substances as persistent organic pollutants). EMA has published today the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices .. The list is often known as REACH restricted substances list or simply as REACH annex XVII. 11), importer (Art. 13), distributor (Art. 14). European Commission (EC) Documents TOPIC Title Author MD Manufacturers Factsheet for Manufacturers of Medical Devices EC Implementation Model for Medical Devices Regulation Step by Step Guide EC MDCG 2019-15 GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES EC IVD Manufacturers step by step Implementation Model for In-Vitro Diagnostic Medical Devices … We’ve added internal links so you can quickly access every Chapter, Article, and Annex! Hazardous Substances under the MDR The current Medical Device Directive (MDD) has requirements contained within it (Annex I, #7.5) for medical devices containing phthalates. 2. If a substance is included in the Authorisation List only due to its health effects, authorisation is not required as health and safety is assessed in connection with the MDR. supplied and a perforated MDR 1 cover with or without ON/ OFF lever. Justification regarding the presence of CMR and/or endocrine-disrupting substances The justification for the presence of such substances shall be based upon: If the concentration is above the specified limit in the medical device, then justification should be drawn based on the below points Title of the standard EN 285:2006+A2:2009 Sterilization – Steam sterilizers – Large sterilizers EN 455-1:2000 Medical gloves for single use – Part 1: Requirements and testing for freedom from holes […] BOMcheck List of Restricted and Declarable Substances www.BOMcheck.net is an industry collaboration sharing one web database system to manage supply chain compliance to substance regulations around the world. I’m studying the new MDR for medical device and I have a question related to classification. This means that distributors of medical devices will have to comply with the new obligations from 26 May 2021. EU MDR Compliance: Taking the Next Step. Distributor; MDR. As per the EU MDR 2017/745, CMR and/ or endocrine -disrupting substances should be present in concentration below 0.1% weight by weight (w/w). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. The EU MDR lists far more substances with regulatory requirements than EU REACH, so compliance with one does not indicate compliance with the other. (11) Union legislation, in par ticular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1) and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplete in respect of cer tain products manufactured utilising der ivatives of tissues or cells of human or igin that are non-viable or are rendered