Changes from plenary report to adopted text

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 1: 1. By way of derogation from Article 18, 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 the incorporation into a cableway installation within the territory of that Member State, of a specific subsystem or safety component which has been designated as a crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body, referred to in Article 18 have not been carried out by a notified body but for which the compliance with all the applicable essential requirements has been demonstrated.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 2 – subparagraph 1: deleted

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – 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 subsystem or safety component may be placed on the market or incorporated into a cableway installation, including at least:

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 3 – point c: (c) an end date of validity of the authorisation, unless otherwise specified, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 3 – point e a (new): (ea) labelling requirements, including radio frequency identification, indicating that the subsystem or safety component was authorised under the internal market emergency mode.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 4: 4. By way of derogation from Article 43a(3), where appropriate, the national competent authority may also amend the conditions and requirements referred to in paragraph 3 of this Article after the deactivation or expiry of the internal market emergency mode.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 5: deleted

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – 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 Regulation with respect to such subsystems or safety components. 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.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 7: 7. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market or incorporation into a cableway installation of subsystems or safety components in accordance with paragraph 1.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 8: 8. The application of Articles 43a to 43g and the use of the authorisation procedure set out in paragraph 1 of this Article shall not affect the application of the relevant conformity assessment procedures laid down in Article 18.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 8 a (new): 8a. Subsystems or safety components 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 Regulation.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43d – paragraph 1 – point a: deleted

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43d – paragraph 1 – 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 requirements set out in Annex II to this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43e– paragraph 1 – point a: (a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation (EU) No 1025/2012 were not adopted;

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43e– paragraph 1 – point a a (new): (aa) where a reference to harmonised standards covering the relevant essential requirements set out in Annex II is not published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and such reference is not expected to be published within a reasonable timeframe during the internal market emergency mode;

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43e – 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 II to this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43e – 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 44(3) and they shall apply to subsystems or safety components 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 the relevant bodies and shall duly consult all relevant stakeholders.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43e – paragraph 4: 4. By way of derogation from Article 43a(3), unless there is sufficient reason to believe that the subsystems or safety components covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the subsystems or safety components in compliance with those common specifications which have been placed on the market shall be deemed compliant with this Regulation 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].

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43e – paragraph 5: 5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential requirements which it aims to cover and which are set out in Annex II, 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.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43f: deleted / (deleted) / (deleted) / (deleted) / (deleted)

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure best 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 subsystems and safety components designated as crisis-relevant goods.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41a – paragraph 1: 1. Articles 41b to 43g of this Regulation shall only apply if the Commission has adopted an implementing act pursuant to Article 14(5) of [the IMERA Regulation].

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41a – paragraph 2: 2. Articles 41b to 43g shall apply exclusively to PPE which has been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41a – paragraph 3 – subparagraph 1: Articles 41b to 43g, except as regards provisions concerning the powers of the Commission, shall apply during the internal market emergency mode.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41a – paragraph 3 – subparagraph 2: deleted

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41a – paragraph 4: deleted

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41b – paragraph 2: 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for conformity assessment of PPE designated as crisis-relevant goods as a matter of priority.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41b – paragraph 4: 4. The prioritisation of applications for conformity assessment of PPE pursuant to paragraph 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for PPE designated as crisis-relevant goods in respect to which they have been notified.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41c – paragraph 1: 1. By way of derogation from Article 19, 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 PPE which has been designated as crisis-relevant goods for which the conformity assessment procedures requiring mandatory involvement of a notified body referred to in that Article have not been carried out by a notified body but for which the compliance with all the applicable essential health and safety requirements has been demonstrated.