Annex I

02017R0745-20250110 → 02017R0745-20260101

ANNEX I GENERAL SAFETY AND PERFORMANCE REQUIREMENTS CHAPTER I GENERAL REQUIREMENTS 1. Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. … 1,188 unchanged words … Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1)., or (b) substances which are classified as endocrine disruptors for human health, of Category 1, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the CouncilRegulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj). and substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified either in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the CouncilRegulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). or, once a delegated act has been adopted by the Commission pursuant 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj). or substances having endocrine-disrupting properties relevant to the first subparagraph of Article 5(3) of human health identified in accordance with Regulation (EU) No 528/2012 of the European Parliament and the CouncilRegulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 concerning the making available on the market of and use of biocidal products (OJ L 167, 27.6.2012, p. 1)., in accordance with the criteria that are relevant to human health amongst the criteria established therein. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj).. 10.4.2. Justification regarding the presence of CMR and/or endocrine-disrupting substances The justification for the presence of such substances shall be based upon: (a) an analysis and estimation of potential patient or user exposure to the substance; (b) an analysis of possible alternative substances, materials or designs, including, where available, information about independent research, peer-reviewed studies, scientific opinions from relevant scientific committees and an analysis of the availability of such alternatives; (c) argumentation as to why possible substance and/ or material substitutes, if available, or design changes, if feasible, are inappropriate in relation to maintaining the functionality, performance and the benefit-risk ratios of the product; including taking into account if the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials; and (d) where applicable and available, the latest relevant scientific committee guidelines in accordance with Sections 10.4.3. 10.4.3 and 10.4.4. 10.4.3. Guidelines on phthalates For When deemed appropriate based on the purposes of Section 10.4., latest scientific evidence, but at least every 5 years, the Commission shall, as soon as possible and by 26 May 2018, provide shall request the relevant scientific committee with a mandate European Chemicals Agency (ECHA) to prepare and update guidelines that shall be ready before 26 May 2020. The mandate for on the committee shall encompass at least a benefit-risk assessment of the presence of phthalates which belong to either of the groups of substances referred to in Section 10.4.1, points (a) and (b) of Section 10.4.1. (b). The benefit-risk assessment shall take into account consider the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments. When deemed appropriate on or when requested by the basis of Commission, the latest scientific evidence, but at least every five years, ECHA shall consult the guidelines shall be updated. Committee for Risk Assessment and the Committee for Socio-economic Analysis. 10.4.4. Guidelines on other CMR and endocrine-disrupting substances Subsequently, In addition to the Commission shall mandate the relevant scientific committee to prepare guidelines as referred to in Section 10.4.3. also 10.4.3, the Commission shall request the ECHA to prepare such guidelines for other substances referred to in Section 10.4.1, points (a) and (b) of Section 10.4.1., (b), where appropriate. Such guidelines shall be prepared in accordance with the process described in Section 10.4.3. 10.4.5. Labelling Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight by weight (w/w), the presence of … 5,895 unchanged words … 18; (ab) for devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended.