Commission Regulation (EU) No 207/2012Show full title

1. Introductory Text

2. Article 1. This Regulation establishes the conditions under which the instructions for...

3. Article 2. For the purposes of this Regulation, the following definitions shall...

4. Article 3. (1) Subject to the conditions set out in paragraph 2,...

5. Article 4. (1) Manufacturers of devices referred to in Article 3 that...

6. Article 5. Manufacturers of devices referred to in Article 3 may provide...

7. Article 6. (1) Manufacturers shall clearly indicate that the instructions for use...

8. Article 7. (1) Where manufacturers provide the instructions for use in electronic...

9. Article 8. Except for medical devices of Class I, as defined in...

10. Article 9. Instructions for use in electronic form which are provided in...

11. Article 10. This Regulation shall enter into force on the 20th day...

12. Signature