Changes from report parliamentary committee draft to plenary report

Change 23

RemovedArticle 2 – paragraph 1, Article 41e – paragraph 5: 5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential health and safety 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 and, if appropriate, may amend the implementing act establishing the common specification in question.

AddedArticle 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.

Regulation (EU) 2016/425

Change 24

AddedArticle 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.

AddedRegulation (EU) 2016/425

AddedArticle 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.

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41c – paragraph 2 – subparagraph 1: deleted

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41c – 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 PPE may be placed on the market, including at least:

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41c – 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;

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41c – paragraph 3 – point e a (new): (ea) labelling requirements, including radio frequency identification, indicating that the PPE was authorised under the internal market emergency mode.

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41c – paragraph 4: 4. By way of derogation from Article 41a(3), where appropriate, the national competent authority may also amend the conditions and requirements referred to in paragraph 3 of this Article also after the deactivation or expiry of the internal market emergency mode.

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41c – paragraph 5: deleted

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41c – 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 PPE. 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.

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41c – paragraph 8: 8. The application of Articles 41a to 41g 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 19.

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41c – paragraph 8a (new): 8a. PPE 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, it shall only be made available on the market after receiving an authorisation under the normal authorisation procedure provided for in this Regulation.

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41d – 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 health and safety 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.

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41e – 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;

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41e – 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;

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41e – paragraph 1 – point b: (b) where severe disruptions in the functioning of the internal market, which led to the activation internal market emergency mode 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 II to this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41e – 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). They shall remain applicable to PPE 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.

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41e – paragraph 4: 4. By way of derogation from Article 41a(3), unless there is sufficient reason to believe that the PPE covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the PPE in compliance with those common specifications which has 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].

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41e – paragraph 5: 5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential health and safety 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.

AddedRegulation (EU) 2016/425

Article 2 – paragraph 1, Article 41f: deleted / (deleted) / (deleted) / (deleted) / (deleted)

Change 25

AddedRegulation (EU) 2016/425

AddedArticle 2 – paragraph 1, Article 41g – 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 PPE designated as crisis-relevant goods.’

Regulation (EU) 2016/426

Change 26

AddedArticle 3 – paragraph 1, Article 40a – title: Application of emergency procedures

AddedRegulation (EU) 2016/426

AddedArticle 3 – paragraph 1, Article 40a – paragraph 1: 1. Articles 40b to 40g of this Regulation shall only apply if the Commission has adopted an implementing act pursuant to Article 14(5) of [the IMERA Regulation] activating Article 26 of [the IMERA Regulation].

AddedRegulation (EU) 2016/426

AddedArticle 3 – paragraph 1, Article 40a – paragraph 2: 2. Articles 40b to 40g shall apply exclusively to appliances and fittings, which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

AddedRegulation (EU) 2016/426

AddedArticle 3 – paragraph 1, Article 40a – paragraph 3 – subparagraph 1: Articles 40b to 40g, except as regards provisions concerning the powers of the Commission, shall apply during the internal market emergency mode remains active.

AddedRegulation (EU) 2016/426

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

AddedRegulation (EU) 2016/426

AddedArticle 3 – paragraph 1, Article 40a – paragraph 4: deleted

AddedRegulation (EU) 2016/426

AddedArticle 3 – 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 appliances and fittings designated as crisis-relevant goods as a matter of priority.

AddedRegulation (EU) 2016/426

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

AddedRegulation (EU) 2016/426

AddedArticle 3 – paragraph 1, Article 40b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for appliances and fittings designated as crisis-relevant goods in respect to which they have been notified.