Chemical restrictions on the table for medical devices in the EU
This article was originally published in SRA
The European Parliament adopted restrictions on chemicals as part of its amendments to the draft Medical Devices Regulation. Nicolas Herbatschek examines the challenges the restrictions would create for the industry.
On 22 October this year, the European Parliament adopted its amendments to the draft Medical Devices Regulation proposed by the European Commission1, including an entirely new regime of restrictions on chemicals that differs from both the commission’s original proposal and the Rapporteur’s report. This regime borrows some elements from other pieces of legislation, in particular the REACH Regulation2 and the Directive on the Restriction of Hazardous Substances3. This article intends to analyze these laws and the challenges they created for industry to better understand the impact that the proposed regime would have on the medical device industry.
The Medical Devices Directive – the existing legislation that the MDR will ultimately replace – already requires that medical devices are designed, manufactured and packed in a way that minimizes chemical risks, with special care for carcinogenic, mutagenic or toxic for reproduction substances (CMR), and imposes a specific labeling obligation for devices that are intended to administer, store or transport certain substances, liquids or medicines and contain phthalates classified as CMR4, such as DEHP, BBP, DBP, and DIBP; phthalates are used as plasticizers in plastic materials.
In its proposal of September 2012, the commission proposed to extend the “special care” requirement to endocrine disrupters, and to extend the phthalates labeling requirements to invasive devices and devices that come into contact with the body. The parliament, however, went much further.
In summary, the amendments would ban CMR and endocrine disrupters in medical devices in which they are present above a concentration of 0.1% by weight. Specific time-limited derogations would be granted by the commission, but reliance on such derogations would trigger additional duties to warn and to justify the use of the substance in the medical device.
Scope of the chemical restrictions
The chemical restrictions would apply to “medical devices or parts thereof ” that:
- “are invasive or come into contact with the body of patients”;
- “(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”.
The amendments refer to the objective function of the medical device, rather than its intended use and, for example, would cover syringes and dialysis devices.
Restricted substances
The amendments adopted by the parliament would restrict CMR and endocrine disrupters.
CMR
The CMR category does not include all chemicals that meet the criteria of CMR. It only includes CMR for which European authorities have agreed on an EU-wide harmonized classification and that are listed in Annex V1 to the Classification, Labeling and Packaging Regulation5. More than 1,000 CMR are currently listed and new substances are added every year by the commission.
This is a considerable number in comparison with other regulatory regimes that already raise significant challenge to industry (144 substances currently on the REACH candidate list and six substances restricted under RoHS).
Certain product-specific EU laws, such as the Toy Safety Directive6, also prohibit CMR, with limited exemptions. However, substitution of chemicals may be far more complicated for medical devices than for toys for which substitution might, for example, only result in the use of less bright colors.
Endocrine disrupters
The category of endocrine disruptors includes all substances having endocrine disrupting properties:
(i) for which there is “scientific evidence of probable serious effects to human health”*;
(ii) which are included in the REACH candidate list; or
(iii) which meet the criteria set forth by a commission recommendation yet to be adopted.
This category raises two difficulties.
First, this category is not limited to a fixed list of chemicals while there is not yet any regulatory definition to clearly determine which substances have endocrine disrupting properties. The definition adopted by the WHO7 is often referred to and could be used as a basis:
An endocrine disruptor is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations.
There are, however, no clear criteria to determine when a substance falls into this definition and the commission is currently struggling to adopt such criteria. The commission was required to identify or propose criteria under the Plant Protection Products Regulation and the Biocidal Products Regulation by December 20138, but it already announced that this will need another year9, if not more.
If the amendments were to be adopted, the medical device industry would be left to struggle with a category of yet unknown restricted chemicals and possibly little time to adapt to the commission’s criteria for endocrine disrupters before the chemical restrictions become applicable.
Second, a sub-category refers to endocrine disrupters included in the REACH candidate list. This list, however, may include endocrine disrupters listed for probable serious effects either to human health or the environment, while only concern for human health is relevant under the proposed MDR. In fact, the four endocrine disrupters currently on the REACH candidate list have all been listed for concern of serious effects to the environment, not to human health. This sub-category should, more likely, be limited to concern to human health.
Maximum concentration value
The amendments would ban CMR and endocrine disrupters above a concentration of 0.1% by weight in “homogeneous materials.” This last term was not defined by the parliament. The same term is defined in RoHS as:
one material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes.10
This threshold should apply to homogeneous materials that are at risk of leaking hazardous substances into patients (or users) rather than all possible homogeneous materials, including those for which there is no risk for patients and users.
The amendments do not indicate how industry may verify whether they comply with the chemical restrictions. It would be economically impossible to test for all chemicals. A more pragmatic solution would be to adopt a risk-based approach which would rely on the probability of presence of a chemical and the trustworthiness of supplier’s chemical disclosure. For example, under RoHS, manufacturers chiefly rely on declarations from their own suppliers and test a device only if the supplier did not submit any reliable declaration but there is some likelihood that the substance is present in the device11.
Derogation
Finally, the amendments would allow the commission to adopt delegated acts to grant derogations for a maximum of four years, which is renewable. A derogation regime may be adopted by a delegated act that would, presumably, be applicable to all manufacturers.
Derogation criteria
A derogation may be granted only if:
- elimination or substitution of the relevant substance is “technically impracticable”;
- “the reliability of substitutes is not ensured”; or
- “the combined negative health or patient safety impact caused by substitution is likely to outweigh the combined health or patient safety benefits thereof ”.
We note that no derogation may be granted if substitution is economically impracticable, ie the use of a substance makes the medical device prohibitively expensive for patients.
These criteria are very general, but similar to those for obtaining an exemption under RoHS12. Manufacturers of medical devices could thus build on the experience that is being formed under RoHS.
Derogation application
A derogation application – as well as an application to renew or revoke a derogation – must include:
- the contact information of the applicant;
- information on the medical device and the specific use of the relevant substance;
- a justification for the derogation;
- an analysis of possible alternatives;
- other relevant information;
- a substitution plan; and
- indication of the information that should be regarded as proprietary.
The amendments give little indication on the information and documents that will convince the commission that the – very general – derogation criteria are met. Experience under RoHS will thus be important for comparison for manufacturers of medical devices.
The additional requirements of alternative analysis and substitution plans are taken from the REACH requirements for authorization13. The REACH authorization regime, however, just started and it will take several months to see how these requirements should be construed and how they could be used by analogy for medical devices under the text adopted by the parliament.
Duties to warn and to justify
Once a derogation has been granted, a manufacturer relying on a derogation must label the device accordingly. The label must appear “on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging”. The manufacturer must also duly justify the application of the use of the relevant substance in the technical documentation of the medical device.
In one half of a sentence of the amendments, one can find three issues:
- its scope should be limited to a concentration “above” 0.1%, not “of 0.1%” and above;
- the threshold should be “0.1% by weight” and not “by mass”; and
- the scope is limited to CMR of categories 1A or 1B rather than all CMR, such as the main provision on chemical restrictions.
If devices or parts thereof, as referred to in the first subparagraph, contain, in a concentration of 0.1% by mass or above, in a homogeneous material, substances which are classified as carcinogenic, mutagenic or toxic to reproduction of category 1A or 1B in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008, or substances identified as endocrine disrupters pursuant to the first subparagraph, and were granted a derogation pursuant to the second or third subparagraph (emphasis added).
This section is presumably intended to mirror the scope of the chemical restrictions, but it differs in three respects:
On this last point, there are indeed three categories of CMR classified mainly according to the level of evidence supporting the conclusion that the substance is a CMR: categories 1A, 1B and 2. Category 2 CMR includes substances that are suspected to be CMR and are typically not subject to the same level of restriction as the higher categories 1A and 1B CMR. For example, the current MDD only imposes labeling requirements on phthalates that are in categories 1A and 1B CMR** and only these two categories can be included in the REACH candidate list (and be subject to authorization), or are prohibited actives substances in biocides14. Any chemical restrictions and the derogation provisions should only be adopted after a sound impact assessment has been conducted.
Practical difficulties with the derogation regime
The amendments would raise several practical difficulties for the medical device industry. The derogation criteria are very general, and it will take time and efforts before being fully understood by industry and regulators. The nascent experience under RoHS and REACH suggests that preparing such derogations will be very time consuming and require significant resources. It may take months to prepare an authorization application under REACH and for the authorities to review it.
The REACH authorization regime and the RoHS exemption regime may require significant resources from regulators although there are currently only six substances restricted under RoHS and 22 substances on the REACH authorization list; these are tiny numbers in comparison to the more than 1,000 substances targeted by the text adopted by the parliament. In the absence of an impact assessment on the number of CMR and endocrine disrupters and the number of medical devices which would be affected, it is unclear how manageable the derogation regime would be for the commission.
Furthermore, no deadline is imposed on the commission to assess a derogation. In comparison, the commission has not yet adopted any exemption under RoHS although the first requests have now been pending for almost two years. In this context the inclusion of a deadline and, possibly an authorization to use the relevant substance in the meantime, would appear to be justified.
This derogation regime will make life more difficult for manufacturers of electronic medical devices. As of 22 July 201415, these devices will be covered by RoHS, which currently restricts six substances, (additional substances will likely be added by the commission in the future). These manufacturers will likely have to meet both RoHS and the proposed MDR at the same time and, if a derogation is justified, proceed with two separate procedures to obtain, on the one hand, a derogation under the proposed MDR for a period of up to four years and, on the other hand, an exemption under RoHS for a period of up to seven years. This duplication unnecessarily increases the administrative burden on industry since the derogation/exemption criteria are similar under both regimes.
Conclusion
In light of the experience gained so far under REACH and RoHS that cover far fewer substances than the amendments, the amendments may be difficult to manage for both the medical device industry and the commission. Hopefully, the EU member states will support the initial proposal from the commission.
* This is a similar wording to the REACH’s category of “substance of equivalent concern” that encompasses endocrine disrupters: “substances – such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) – for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.” (Art. 57.f), REACH)
** Annex I, Section II.7.5, second alinea, Medical Devices Directive: “If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.” Note that Directive 67/548/EEC is being gradually repealed by the CLP Regulation and categories 1 and 2, in accordance with Annex I to Directive 67/548/ EEC, correspond to categories 1A and 1B, in accordance with the CLP Regulation.
References
1. Scrip Regulatory Affairs passim
2. Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, OJ, 30 December
2006, L396 (1-849), http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:396:0001:0849:EN:PDF & OJ, 29 May 2007, L136 (3-280), http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:136:0003:0280:EN:PDF
3. Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment, OJ, 1 July 2011, L174 (88-110), http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:en:PDF
4. Section II.7.5, Annex I, see Directive 2007/47, OJ, 21 September 2007, L247, 21-55, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:EN:PDF, amending Council Directive 93/42/EEC concerning medical devices, OJ, 12 July 1993, L169 (1-43), http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1993:169:0001:0043:EN:PDF
5. Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures, OJ, 31 December 2008, L353 (1-1355), http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:en:PDF
6. Sections III.3 to 5, Annex II, Directive 2009/48/EC on the safety of toys, OJ, 30 June 2009, L170 (1-37), http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:170:0001:0037:en:PDF
7. WHO, Global Assessment of the State-of-the-science of Endocrine Disruptors, (2002) WHO/PCS/EDC/02.2, page 1, www.who.int/ipcs/publications/new_issues/endocrine_disruptors/en/
8. Annex II, Section 3.6.5, Regulation (EC) 1107/2009 concerning the placing of plant protection products on the market, OJ, 24 November 2009, L309 (1-50), http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:309:0001:0050:EN:PDF and Art 5.3, Regulation (EU) 528/2012 concerning the making available on the market and use of biocidal products, OJ, 27 June 2012, L167 (1-123), http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:167:0001:0123:EN:PDF, and Art 138.7 of REACH (see Reference 2), which required action from the European Commission by 1 June 2013
9. Chemical Watch, EU Commission Delays Action on EDC Criteria, 12 September 2013, http://
chemicalwatch.com/16371/eu-commission-delaysaction-on-edccriteria?q=endocrine%20disruptors
10. Art 3.20, RoHS, see Reference 3
11. See EN 50581-2012: Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances, OJ, 23 November 2012,
C363 (6-7), http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2012:363:0006:0007:EN:PDF
12. Art 5.1.a), RoHS, see Reference 3
13. Art. 62.4.e) and f), REACH, see Reference 2
14. Art. 5.1.a) to c), Regulation (EU) No 528/2012, see Reference 8 In comparison, see Section III.3, Annex II, Toy Safety Directive, also restrict category 2 CMR, see Reference 6
15. Art 4.3, RoHS, see Reference 3 (RoHS will apply to in vitro diagnostic medical devices as of
22 July 2016)
Nicolas Herbatschek is an associate in the EU regulatory team of the law firm Hunton & Williams. He is based in Brussels, Belgium. Email: [email protected].