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RoHS, REACH and the Rest: EU Substances Regulation Applicable to Medical Devices and IVDs

RoHS, REACH and the Rest: EU Substances Regulation Applicable to Medical Devices and IVDs
An overview of everything you need to know about EU legislation restricting hazardous substances from use in medical and IVD devices placed on the market in EU member states.

An overview of everything you need to know about EU legislation restricting hazardous substances from use in medical and IVD devices placed on the market in EU member states.

Dr. Alex Martin

Medical and in vitro diagnostic (IVD) devices are among the most highly regulated products made and marketed in the world. Within the EU, device safety and performance requirements are laid out in sector-specific legislation that includes the Medical Devices and In Vitro Diagnostic Devices Directives (Directives 93/42/EEC and 98/79/EC). However, environmental requirements are set in other legislation that restricts hazardous substances from use in products.

This article presents an overview of EU legislation restricting hazardous substances from use in medical and IVD devices placed on the market in EU member states. If, as a business, you have a market presence in the EU such that you distribute and/or sell medical and IVD devices in one or more member states, you will have obligations to fulfill. Additionally, even if your business is without EU offices and you simply manufacture and export devices, the legislation remains significant: Your customers will expect your devices to comply and for you to demonstrate this upon request.

Restriction of Hazardous Substances (RoHS) Directive, 2011/65/EU

The RoHS Directive applies when medical and IVD devices within the scope of the aforementioned directives—93/42/EEC and 98/79/EC—also constitute items of “electrical and electronic equipment” (EEE), meaning they are dependent on electric currents or electromagnetic fields to work and are designed for use with a voltage range not exceeding 1000 V for ac and 1500 V for dc. If this is applicable, the device is a RoHS “Category 8” item under Annex I of the directive.

Under RoHS, medical and IVD devices must not contain cadmium (Cd), lead (Pb), mercury (Hg), hexavalent chromium (CrVI), polybrominated biphenyls (PBB), or polybrominated diphenyl ethers (PBDE) in quantities not exceeding the following maximum concentration values:

  • 0.01% by weight for Cd.
  • 0.1% by weight for each of Pb, Hg, CrVI, PBB and PBDE.

A further point of significance is that all restrictions under RoHS apply to the use of the substances in homogeneous materials, meaning any material that cannot be mechanically disjointed into different materials (e.g., individual types of plastics, ceramics, and glass). ?

The RoHS Directive sets varying obligations for businesses depending on what they do in the supply chain. The directive distinguishes between manufacturers, authorized representatives, importers, and distributors. The UK Government Department for Business summarizes the various obligations in a helpful table on its website, which is reproduced in Table I below.

Legal ObligationsManufacturerAuthorized RepresentativeImporterDistributor
 

Any supplier of
an EEE for distribution, consumption or use in the course of a commercial activity and markets it under their own name 

Anyone with a written mandate from a manufacturer to carry out administrative tasks on their behalf when placing EEE on the market 

Anyone who imports EEE from outside the EU and places it on the EU marketAnyone in the supply chain, other than the manufacturer or importer, who makes EEE available on
the EU market
Design and manufacture EEE in compliance with RoHS

?

   
Place only compliant EEE on the EU market

?

 

?

?

Draw up technical documentation

?

   
Implement production control systems and checks to ensure compliance

?

   
Draw up an EU declaration of conformity

?

   
Affix CE mark

?

   
Ensure the EEE is accompanied by required documents  

?

?

Ensure that technical documentation, in addition to the declaration of conformity, remains available for 10 years after the EEE is placed on the market

?

?

?

 
Ensure that the EEE has been CE marked by the manufacturer  

?

?

Keep a register of all non-compliant and/or recalled EEE

?

 

?

 
Ensure that the manufacturer keeps a register of all non-compliant and/or recalled EEE  

?

 
Ensure that the manufacturer has carried out an appropriate assessment of conformity  

?

 
Ensure that the manufacturer has drawn up technical documentation  

?

 
Ensure that theEEE remains compliant for as long as it is produced

?

   
Ensure that the EEE is marked with type/serial/batch number for identification

?

 

?

?

Ensure that the EEE is marked with the manufacturer’s trademark/trade name and address

?

  

?

Ensure that the EEE is marked with the importer’s trade name and address  

?

?

Take corrective measures to ensure that any non-compliantEEE becomes compliant

?

 

?

?

If requested, provide the NMRO with all the information required to demonstrate conformity

?

?

?

?

Cooperate with the NMRO and take any action it requests to ensure conformity

?

?

?

?

Meet all manufacturer obligations if you market EEEunder your own trademark/trade name  

?

?

Table I. Shown here are the obligations of all economic operators affected by RoHS.

Batteries Directive, 2006/66/EC

If a medical or IVD device incorporates a battery, it must comply with requirements laid down in the Batteries Directive. Among these requirements are substance restrictions:

  • The battery must not contain more than 0.0005% of mercury by weight.
  • The battery must not contain more than 0.002% of cadmium by weight. ?The following labeling requirements also apply, while the directive additionally specifies sizes and dimensions that need to be adhered with.
  • The battery must be marked with the separate collection symbol (crossed-out wheelie bin).
  • If the battery contains more than 0.002% of cadmium by weight, it must be marked with the ?chemical symbol “Cd” below the crossed-out wheelie bin.
  • If the battery contains more than 0.004% of lead by weight, it must be marked with the ?chemical symbol “Pb” below the crossed-out wheelie bin. ?

Packaging and Packaging Waste Directive, 94/62/EC ?

This directive applies to all packaging used to bring medical and IVD medical devices to market, including the retail pack, but also transit packaging such as outer cartons, plus the likes of pallet straps, shrink wrap, and so on. The directive restricts certain heavy metals from use: cadmium, lead, mercury, and hexavalent chromium—or any combination of these heavy metals—must not exceed 100 parts per million (ppm) or 0.01% by weight. These restrictions apply to packaging plus any packaging components calculated as a whole unit. Note, however, that concentration is measured as a proportion of the weight of the packaging item itself, and not by weight in each homogeneous material as required by RoHS. ?

REACH Regulation, No 1907/2006 ?

REACH is the EU’s overarching piece of chemicals legislation, affecting the manufacture, import, and marketing of all substances and mixtures as well as the use of substances in products including medical and IVD devices and their associated packaging. ?REACH takes a systematic approach to chemicals management that entails collecting data on substances and preparations marketed and used in the EU (Registration), evaluating the data (Evaluation), and imposing limits on the use of hazardous substances (Authorization and Restrictions). The European Chemicals Agency oversees all relevant administration while also having responsibility for Evaluation. ?REACH makes a distinction between medicinal products and medical and IVD devices, the latter including the likes of blood glucose meters, catheters, and contact lenses that, with their packaging, constitute REACH “articles.”?Authorization is the protocol within REACH for identifying and controlling the use of Substances of Very High Concern (SVHCs), with the longer term aim of finding alternatives. SVHCs are first identified based on meeting one or more criteria:

  • Carcinogenic, mutagenic, or toxic to reproduction (CMR).
  • Persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative ?(vPvB).
  • Of equivalent level of concern, for example endocrine disrupters. ?

Once identified, a SVHC is next put on the REACH “Candidate List,” meaning it becomes a candidate for further control, which could be that the chemical cannot be used in the EU unless authorizations are granted for specific uses. This only occurs when the SVHC is moved from the Candidate List to Annex 14 of the REACH Regulation, though.

Regardless of the potential transfer to Annex 14, the addition of SVHCs to the Candidate List will result in manufacturers of medical and IVD devices—as REACH “articles”—having to determine whether they contain SVHCs at >0.1% weight by weight (w/w) of articles and, if they do, provide information to recipients in the supply chain (e.g., distributors, retailers). As a minimum, manufacturers or importers must communicate the name(s) of the substance(s) on the Candidate List that are found in their articles above 0.1% w/w. If manufacturers or importers also have particular information pertaining to the safe use of their articles because they contain one or more SVHCs, then this must be communicated, too. This information must be provided to business recipients automatically when the items are supplied. Of further note is the recent European Court of Justice ruling that suppliers must provide to recipients SVHC information on all constituent component parts that meet the definition of articles as well as the finished articles.

The communication requirement applies from the time new substances are added to the Candidate List.

There is also a communication requirement relating to consumer requests for information. If faced with a request from a consumer, the manufacturer must provide the names of the SVHCs found in their device (and packaging, manuals, etc.) above 0.1% w/w as well as any particular information pertaining to safe use within 45 days.

At the time of writing, there are 163 SVHCs in the Candidate List.

Substance restrictions are listed in Annex 17 of the REACH Regulation. Most permit a general use except where specifically restricted, but a few are total bans. Only a limited number of these substances could potentially be present in medical and IVD devices though.

Concluding Remarks

This article has outlined key EU laws setting substance restrictions applicable to medical and IVD devices. Businesses need to understand their obligations in these regards. Such obligations span meeting substance restrictions as well as demonstrating compliance through the compilation and retention of technical documentation and information sharing with customers. Complexity comes in the number of substances to which requirements now apply and the fact that this number is ever expanding; the REACH Candidate List, for instance, is being added to on a six-monthly basis. Not only this, but the varied and large number of materials used in medical and IVD devices means that this complexity extends into supply: For device brand owners positioned downstream in supply chains, it is likely they will need to engage with multiple direct suppliers and, in turn, seek to influence many of their suppliers’ suppliers to ensure both understanding of and adherence to these substance restrictions and information obligations. With these remarks in mind, it is advisable to approach compliance not just from an internal technical perspective, but from one that gives consideration to supplier relationships and whether partnering with specialist regulatory compliance service providers—who might perform, say, legal monitoring and compliance screening assessments on your behalf—makes business sense.

Don't miss the BIOMEDevice San Jose conference and expo, December 2-3, 2015 at the San Jose Convention Center.

Dr. Alex Martin is senior regulatory consultant at Edif ERA. Reach him at [email protected]

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