Division 1 This Regulation shall not apply to light sources specifically tested and approved to operate:

1. (a)

   in radiological and nuclear medicine installations, as defined in Article 3 of Council Directive 2009/71/Euratom^f1;

2. (b)

   for emergency use;

3. (c)

   in or on military or civil defence establishments, equipment, ground vehicles, marine equipment or aircraft as set out in Member States' regulations or in documents issued by the European Defence Agency;

4. (d)

   in or on motor vehicles, their trailers and systems, interchangeable towed equipment, components and separate technical units, as set out in Regulation (EC) No 661/2009 of the European Parliament and of the Council^f2, Regulation (EU) No 167/2013 of the European Parliament and of the Council^f3 and Regulation (EU) No 168/2013 of the European Parliament and of the Council^f4;

5. (e)

   in or on non-road mobile machinery as set out in Regulation (EU) 2016/1628 of the European Parliament and of the Council^f5 and in or on their trailers;

6. (f)

   in or on interchangeable equipment as set out in Directive 2006/42/EC of the European Parliament and of the Council^f6 intended to be towed or to be mounted and fully raised from the ground or that cannot articulate around a vertical axis when the vehicle to which it is attached is in use on a road by vehicles as set out in Regulation (EU) No 167/2013;

7. (g)

   in or on civil aviation aircraft as set out in Commission Regulation (EU) No 748/2012^f7;

8. (h)

   in railway vehicle lighting as set out in Directive 2008/57/EC of the European Parliament and of the Council^f8;

9. (i)

   in marine equipment as set out in Directive 2014/90/EU of the European Parliament and of the Council^f9;

10. (j)

    in medical devices as set out in Council Directive 93/42/EEC^f10 or Regulation (EU) 2017/745 of the European Parliament and of the Council^f11 and in vitro medical devices as set out in Directive 98/79/EC of the European Parliament and of the Council^f12.

For the purpose of this point, ‘specifically tested and approved’ means that the light source:

• has been specifically tested for the mentioned operating condition or application, according to the European legislation mentioned or related implementing measures, or relevant European or international standards or, in the absence of these, according to relevant Member States legislation; and

• is accompanied by evidence, to be included in the technical documentation, in the form of a certificate, a type approval mark, a test report, that the product has been specifically approved for the mentioned operating condition or application; and

• is placed on the market specifically for the mentioned operating condition or application, as evidenced at least by the technical documentation, and except for point (d), information on the packaging and any advertising or marketing materials.