Changes from report parliamentary committee draft to plenary report

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40c – paragraph 1: 1. By way of derogation from Article 14, the competent national authority, after carrying out a risk assessment, may authorise, on a duly justified request from an economic operator established in its Member State, the placing on the market or putting into service within the territory of that Member State, of a specific apparatus which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body referred to in Article 14 have not been carried out by a notified body but for which the compliance with all the applicable essential safety requirements has been demonstrated.

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40c – paragraph 2 – subparagraph 2: deleted

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40c – paragraph 3 – introductory part: 3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the apparatus may be placed on the market or put into service, including at least:

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40c – paragraph 3 – point c: (c) an end date of validity of the authorisation, which, unless otherwise specified, cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40c – paragraph 3 – point ea: (ea) labelling requirements, including radio frequency identification, indicating that the apparatus was authorised under the internal market emergency mode.

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40c – paragraph 4: 4. By way of derogation from Article 40a(3), where appropriate, the national competent authority may also amend the conditions and requirements referred to in paragraph 3 after the deactivation or expiry of the internal market emergency mode.

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40c – paragraph 5: deleted

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40c – paragraph 6: 6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Directive with respect to such apparatus. The market surveillance authorities shall keep all records related to products authorised under a derogation for a period of 10 years. They shall make those records available to other market surveillance authorities upon request.

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40c – paragraph 8: 8. The application of Articles 40a to 40g and the use of the authorisation procedure set out in paragraph 1 of this Article shal not affect the application of the relevant conformity assessment procedures laid down in Article 14.

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40c – paragraph 8 a (new): 8a. Apparatus subject to derogation under paragraph 1 shall remain valid for six months after deactivation or expiration of the internal market emergency mode. After this period, they shall only be made available on the market after receiving an authorisation under the normal authorisation procedure provided for in this Directive.

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40d – paragraph 1 – introductory part – point b: (b) where severe disruptions in the functioning of the internal market, which were taken into consideration when activating the internal market emergency mode in accordance with Article 14 of [the IMERA Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential health and safety requirements set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40e – paragraph 1 – point –a (new): (-a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation (EU) No 1025/2012 were not adopted;

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40e – paragraph 2 – point a: (a) where a reference to harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive has not been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe during the internal market emergency mode;

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40e – paragraph 1 – point b: (b) where severe disruptions in the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 14 of [the IMERA Regulation] significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential requirements set out in Annex I to this Directive already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40e – paragraph 2: 2. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 41(2a). They shall apply to apparatus placed on the market until the last day of the period for which the internal market emergency mode remains active. When preparing the draft implementing act establishing the common specification, the Commission shall take into account the views of relevant bodies and shall duly consult all relevant stakeholders.

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40e – paragraph 4: 4. By way of derogation from Article 40a(3), unless there is sufficient reason to believe that the apparatus covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the apparatus in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the internal market emergency mode in accordance with [the IMERA Regulation].

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40e – paragraph 5: 5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential safety requirements which it aims to cover and which are set out in Annex I, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information. The Commission may amend, where appropriate, the implementing act establishing the common specification in question.

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40f: deleted / (deleted) / (deleted) / (deleted) / (deleted)

AddedDirective 2014/30/EU

AddedArticle 7 – paragraph 1 – subparagraph 1, Article 40g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure all reasonable efforts are made to provide assistance to other market surveillance authorities during an internal market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for apparatus, designated as crisis-relevant goods.’

Directive 2014/31/EU

Change 35

ChangedArticle 8 – paragraph 1, Article 40a – paragraph 1: 1. Member States shall ensure that measures taken to transpose Articles 40b to 40g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 2314(5) of [the IMERA Regulation] with respect to this Directive.Regulation].

Directive 2014/31/EU

Change 36

AddedArticle 8 – paragraph 1, Article 40a – paragraph 3 – subparagraph 1: Member States shall ensure that measures taken to transpose Articles 40b to 40g apply during the internal market emergency mode.

AddedDirective 2014/31/EU

AddedArticle 8 – paragraph 1, Article 40a – paragraph 3 – subparagraph 2: deleted

AddedDirective 2014/31/EU

AddedArticle 8 – paragraph 1, Article 40a – paragraph 4: deleted

AddedDirective 2014/31/EU

AddedArticle 8 – paragraph 1, Article 40b – paragraph 2: 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for conformity assessment of instruments designated as crisis-relevant goods as a matter of priority.

AddedDirective 2014/31/EU

AddedArticle 8 – paragraph 1, Article 40b – paragraph 4: 4. The prioritisation of applications for conformity assessment of instruments pursuant to paragraph 2 and 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

AddedDirective 2014/31/EU

AddedArticle 8 – paragraph 1, Article 40b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for instruments designated as crisis-relevant goods in respect of which they have been notified.

AddedDirective 2014/31/EU

AddedArticle 8 – paragraph 1, Article 40c – paragraph 1: 1. By way of derogation from Article 13, the competent national authority, after carrying out a risk assessment, may authorise, on a duly justified request from an economic operator established in its Member State, the placing on the market within the territory of that Member State, of a specific instrument which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body referred to in Article 13 have not been carried out by a notified body but for which the compliance with all the applicable essential requirements has been demonstrated.

AddedDirective 2014/31/EU

AddedArticle 8 – paragraph 1, Article 40c – paragraph 2 – subparagraph 2: deleted

AddedDirective 2014/31/EU

AddedArticle 8 – paragraph 1, Article 40c – paragraph 3 – introductory part: 3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the instrument may be placed on the market or put into service, including at least:

AddedDirective 2014/31/EU

AddedArticle 8 – paragraph 1, Article 40c – paragraph 3 – point c: (c) an end date of validity, unless otherwise specified, of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

AddedDirective 2014/31/EU