Commission Delegated Directive (EU) 2022/1632 of 12 May 2022 amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of lead in certain magnetic resonance imaging devices (Text with EEA relevance)

• CELEX: Delegated Directive (EU) 2022/1632
• Articles: 5

Article 1

Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

Article 2

1.   Member States shall adopt and publish, by 28 February 2023 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate the text of those provisions to the Commission.

They shall apply those provisions from 1 March 2023.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law, which they adopt in the field covered by this Directive.

Article 3

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Article 4

This Directive is addressed to the Member States.

Schedules & Appendices

ANNEX

ANNEX

In Annex IV to Directive 2011/65/EU, in entry 27, the following points (c) and (d) are added:

‘(c)

MRI non-integrated coils, for which the Declaration of Conformity of this model is issued for the first time before 23 September 2022, or

(d)

MRI devices including integrated coils, which are used in magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, for which the Declaration of Conformity is issued for the first time before 30 June 2024.

Expires on 30 June 2027.’