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SAFEGUARDS | Electrical Medical Devices NO. 045/17

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Eudamed (EU databank medical devices), has released a timetable for the expected completion of legislation towards the amended Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in the 3rd steering committee.

In the final draft of the amended regulations, the chemical requirements are clearly defined. In particular, MDR points out that labelling is necessary if a device, part or material contains CMR1 1A, 1B or EDCs2 higher than 0.1% (w/w). 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.

The new EU MDR and IVDR have been discussed since 2012. After a long process, Eudamed released a timetable related to the expected completion of legislation for the amendment of MDR and IVDR in the 3rd steering committee, as below. According to the following timetable, the official version of the amended MDR and IVDR will probably be published by the end of May 2017.

Timetable [1]

  • At the end of January 2017 the English versions of the new MDR and IVDR are expected to be ready
  • By the middle of February 2017, English versions as well as the translations into all European Union languages will be distributed among stakeholders

  • By the beginning of March 2017 the Council is expected to accept this version

  • By the beginning of April 2017 the European Parliament should adopt the Regulations

  • Formal publication would then take place at the end of April 2017

  • Official entry into power by the end of May 2017

  • The MDR would then be applicable from the end of May 2020
  • The IVDR would then be applicable from the end of May 2022

On February 22, 2017 Eur-lex released the final draft of the amended MDR [2] and IVDR [3]. In the section 10.4.1 and 10.4.5 of draft MDR and section 10.3 of draft IVDR the chemical requirements are listed. Additionally, MRD includes some special guidelines on phthalates and CMR or endocrine disruption substances. MDR indicates that a label is necessary if a device, part or material contains CMR 1A, 1B or EDCs in a concentration higher than 0.1% (w/w). Information or precautionary measures shall be given in the device instructions for use with or treatment of children, treatment of pregnant or breastfeeding women, treatment of other patient groups considered particularly vulnerable to such substances and/or materials in order to prevent harm from CMR 1A, 1B or EDCs. More details can be found in the following table 1.

Temporary documents      Chemical requirements
Final draft of
amended medical device regulation

Section 10.4.1

Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by substances or particles, including wear debris, degradation products and processing residues that may be released from the device.

Devices, or those parts thereof or those materials used therein that:

  • are invasive and come into direct contact with the human body,
  • (re)administer medicines, body liquids or other substances, including gases, to/from the body, or
  • transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body,

shall only contain the following substances in a concentration that is above 0,1 % (w/w) where justified pursuant to Section 10.4.2, then a labelling on devices or packaging needs to be accomplished according to section 10.4.5.

  1. CMR 1A or 1B in part 3 of Annex VI of CLP3 Regulation (EC) No 1272/2008
  2. EDCs identified by REACH4 Regulation (EC) 1907/2006 or BPR5 Regulation (EU) 528/2012                

Section 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 those substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances. If the intended use of such devices includes treatment of children, treatment of pregnant or breastfeeding women, treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use.

Final draft of amended IVD
regulation

Section 10.3

Devices shall be designed and manufactured in such a way as to reduce to a level as low as reasonably practicable the risks posed by substances or particles, including wear debris, degradation products and processing residues, that may be released from the device.

Special attention shall be given to substances:

  1. CMR 1A or 1B in part 3 of Annex VI of CLP Regulation (EC) No 1272/2008
  2. EDCs identified by REACH Regulation (EC) 1907/2006

1 CMR: Carcinogenic, Mutagenic or toxic to Reproduction

2 EDCs: Endocrine disrupting chemicals

3 CLP: Classification, Labelling and Packaging of substances and mixtures

4 REACH: Registration, Evaluation, Authorization and Restriction of Chemicals

5 BPR: Biocidal Product Regulation

If you would like to learn more about how SGS can support you on medical devices, please visit www.sgs.com/consumermedicaldevices

For enquiries, please contact:

Richie Chang
SGS Taiwan Ltd. Multi-Chemical Lab (Taipei) Asst. Manager
+886 2 22993279

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