COMPLIANCE OF CHEMICALS IN MEDICAL DEVICES

Design and manufacture

(…) 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. (…)

Annex I, article 10.4.1

Restrictions of substances

(…) Devices (…) shall only contain the following substances in a concentration that is above 0,1 % weight by weight (w/w) where justified (…):

(a) substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’) (…); or

(b) substances having endocrine-disrupting properties (…).

Annex I, article 10.4.1

Conditions for exemption

Justification regarding the presence of CMR and/or endocrine-disrupting 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;(…) and

(d) where applicable and available, the latest relevant scientific committee guidelines (…).

Annex I, article 10.4.2

Guidelines on phthalates

(…) the Commission shall (…) provide the relevant scientific committee with a mandate to prepare guidelines (...).

The mandate for 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 points (a) and (b) of Section 10.4.1.

The benefit-risk assessment shall take into account 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 the basis of the latest scientific evidence, but at least every five years, the guidelines shall be updated.

Annex I, article 10.4.3

Guidelines on other CMR and endocrine-disrupting substances

(…) the Commission shall mandate the relevant scientific committee to prepare guidelines (…)

Annex I, article 10.4.4

Labelling

Where devices (...) 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. (...)

Annex I, article 10.4.5

Latex

Substance to be declared to the Unique Device Identification (UDI) database

Annex VI, part B