Directive 2013/35/EU of the European Parliament and of the CouncilShow full title

Article 10 Derogations

1. By way of derogation from Article 3 but without prejudice to Article 5(1), the following shall apply:

(a) exposure may exceed the ELVs if the exposure is related to the installation, testing, use, development, maintenance of or research related to magnetic resonance imaging (MRI) equipment for patients in the health sector, provided that all the following conditions are met:

(i)

the risk assessment carried out in accordance with Article 4 has demonstrated that the ELVs are exceeded;

(ii)

given the state of the art, all technical and/or organisational measures have been applied;

(iii)

the circumstances duly justify exceeding the ELVs;

(iv)

the characteristics of the workplace, work equipment, or work practices have been taken into account; and

(v)

the employer demonstrates that workers are still protected against adverse health effects and against safety risks, including by ensuring that the instructions for safe use provided by the manufacturer in accordance with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(1) are followed;

(b) Member States may allow for an equivalent or more specific protection system to be implemented for personnel working in operational military installations or involved in military activities, including in joint international military exercises, provided that adverse health effects and safety risks are prevented;

(c) Member States may allow, in duly justified circumstances and only for as long as they remain duly justified, for the ELVs to be temporarily exceeded in specific sectors or for specific activities outside the scope of points (a) and (b). For the purposes of this point, ‘duly justified circumstances’ shall mean circumstances in which the following conditions are met:

(i)

the risk assessment carried out in accordance with Article 4 has shown that the ELVs are exceeded;

(ii)

given the state of the art, all technical and/or organisational measures have been applied;

(iii)

the specific characteristics of the workplace, work equipment, or work practices have been taken into account; and

(iv)

the employer demonstrates that workers are still protected against adverse health effects and safety risks, including using comparable, more specific and internationally recognised standards and guidelines.

2. Member States shall inform the Commission of any derogation under points (b) and (c) of paragraph 1 and shall state the reasons that justify them in the report referred to in Article 15.

(1)

OJ L 169, 12.7.1993, p. 1.