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Is January 5th 2021 on your radar?

Where focus on materials and chemical compositions have historically gotten a lot of attention in the medical device industry, the major focus has always been on bio compatibility, (clinical) performance and safety requirements. With the medical device industry furthermore being caught up in a turmoil of new and changed medical device specific regulations, it is almost understandable that the impact and obligations of other regulations are not receiving the attention they deserve.

The Medical Device Directive (2017/745), in its General Safety and Performance Requirements (GSPR), particularly in paragraph 10.4, defines requirements for substances in medical devices which are carcinogenic, mutagenic or toxic to reproduction (CMR), substances having endocrine-disrupting properties

But there is another set of regulations related to the protection of human health and environment from the risks that can be posed by chemical substances. These regulations are more broadly applicable than just medical devices and some of these regulations have been around since the early part of this century.

Now there is one particular regulation that is nearing an important deadline, which should be on the radar of medical device industry, i.e. the EU REACH regulation (1907/2006). As per January 5th 2021, all products containing more than 0.1% w/w of a substance of very high concern (SVHC) need to be registered in the European ECHA-SCIP database.

REACH introduces new requirements on EU component suppliers to provide substance declarations (Article 33) and comply with substance restrictions (Article 67) when they supply their articles (e.g. components and sub-assemblies) to the next manufacturer in the supply chain. 

REACH is fundamentally different to RoHS in that it, e.g.:

  • takes a more holistic approach over the supply chain, defining obligations for manufacturers, importers, subcontractors and suppliers,
  • creates the obligation to disclose whether their product exceeds 0.1% w/w of any SVHC,
  • not just banns selected chemicals from electronic products but addresses all products, components and substances on the EU market

Further information can be found at: https://echa.europa.eu/home

Where other regulations (e.g. WEEE, ROHS, CHINA RoSH, PROP65) define substance requirements and introduce labelling requirements, REACH aims to increase transparency across the supply chain and over the full lifetime of the product by creating a central database, i.e. ECHA-SCIP. 
Thus this ECAH-SCIP database centrally gathers structured and searchable information on where SVHC’s are contained in products, providing consumers and waste operators, as well as other actors in the supply chain, NGOs and authorities optimized access to this information.

This implies that manufacturers, importers, along with their suppliers and subcontractors, need to either confirm the absence or determine the content of any of the SVHC’s in their product and, if these exceed the 0.1% w/w limit, prepare for registering/reporting in ECHA-SCIP. 
Under REACH, manufacturers furthermore need to be able to respond, free of charge, to any user/consumer requirements inquiries concerning SVHC’s in their products within 45 days.

The official list of SVHCs currently already contains 205 substances and can be found at https://echa.europa.eu/candidate-list-table

All-in-all, this is not a simple undertaking because:

  • You need to work intensively with your, possibly multi-tiered, supply chain partnersto gather the required information.
    From the information received by you supply chain partners, you need to calculate the percentage weight by weight (w/w) on product level to determine your compliance.
  • You need to consider product variants, options and accessories.
  • You need to gather all required date elements for reporting to SCIP, including some “less common” attributes like:
    • The Combined Nomenclature (CN) code from the European Union – TARIC – list
    • The CAS number of the specific substance belonging to a group entry
  • This is not a one-time exercise, but it requires a robust change management process. Next to design changes warranting updates of the ECHA-SCIP registration, it can be suppliers and subcontractors changing their material composition and, last but not least, the SVHC list is periodically updated.
  • Overall, a risk based approach should be followed, whereby risk assessment could be performed from multiple perspectives, e.g. assessing
    • Environmental compliance risk.
    • Supply chain risk.
    • Business risk.

Where Qserve is obviously not an analytical laboratory that can perform chemical analysis for you , it does offer a number of important and related to the medical devices industry. Qserve can perform, or support you in performing:

  • Bill of Material (BoM) Assessments against REACH, RoHS, Prop65, China RoSH
  • Environmental Risk Assessment
  • Labelling reviews
  • Implementing environment regulations in your QMS
  • Supplier controls and contracts
  • Supplier audits
  • Training

Regards,

Ra’na Saleem - Consultant & SME environmental compliance 
René Schings - Pr. Consultant

René Schings
Post date: September 01, 2020
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