Environmental Assessment


Medical Devices Regulation

The Medical Device Regulation (MDR) (EU) 2020/561 on medical devices, amending the previous Regulation (EU) 2017/745, has been issued. This amendment postponed the date of application to May 2021, providing a 4-year transition period after which the MDR would start requiring more from manufacturers. The MDR includes the control of chemicals in Medical Devices.

Once the Regulation is applied, certificates for both the Medical Devices Directive 93/42/EEC (MDD) and Implantable Medical Devices Directive 90/385/EEC (AIMDD), are void as of May 27th, 2024.

According to the MDR, the conformity obligations listed in this table must be met as of May 26th, 2021, and your medical products assessed: 




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


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


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

Annex VI, part B

This medical devices regulation is part of the European CE marking requirements.

Enviropass can assist you with the Medical device environmental requirements. Ask for a free consultation!