2022-11-22 23:00:00
I. – The order
II. – The Public Health Code is amended as follows:
1° In the first paragraph of II of Article L. 1111-3-2, the words: “custom-made medical device or its accessory” are replaced by the words: “custom-made device mentioned in Article 1 of the (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017”;
2° In the first paragraph of Article L. 1111-3-3, the words: “medical devices or their accessories” are replaced by the words: “mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament Parliament and of the Council of 5 April 2017”;
3° In the second paragraph of Article L. 1151-1, following the word: “prescribe”, are inserted the words: “, practice them, use them” and the words: “in accordance with” are replaced by the words: “without prejudice, where applicable, to compliance with”;
4° A l’article L. 1151-2 :
a) The first paragraph reads as follows:
“The practice of acts, processes, techniques and methods relating to the groups of products mentioned in Annex XVI of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 or the practice of other acts, processes, techniques and methods for aesthetic purposes other than those covered by Article L. 6322-1 may, if it presents risks to human health, be subject to rules, defined by decree issued following consulting the High Authority for Health , relating to the training and qualification of the professionals who can implement them, to the declaration of the activities carried out and to the conditions of performance. » ;
b) The second paragraph is supplemented by the words: “, taken following the opinion of the High Authority for Health”;
5° In the second paragraph of Article L. 1333-25, the words: “mentioned in Article L. 5211-3-2” are replaced by the words: “within the meaning of Article 61 of Regulation (EU ) 2017/745 of the European Parliament and of the Council of 5 April 2017”;
6° A l’article L. 5461-6 :
a) After the words: “medical device”, the word: “and” is replaced by the word: “or”;
b) After the words: “medical devices”, are inserted the words: “or its accessories”;
7° In 12° of Article L. 5461-9, following the words: “medical device”, the word: “and” is replaced by the word: “or”;
8° In articles L. 5471-2 and L. 5472-3, the word: “book” is replaced by the word: “chapter”;
9° Title VII of Book IV of Part Five is supplemented by a Chapter III worded as follows:
“financial penalties imposed by the administrative authority responsible for competition and consumption
« Art. L.5473-1. – I. – In the field of competence determined in II of article L. 5211-2 and in II of article L. 5221-2, the administrative authority in charge of competition and consumption mentioned in Article L. 522-1 of the Consumer Code may pronounce a financial penalty once morest the author of a breach mentioned in Articles L. 5461-9 and L. 5462-8, in accordance with the procedure provided for in Chapter II of Title II of Book V of the Consumer Code.
“II. – The administrative authority in charge of competition and consumption may combine this financial penalty with a daily penalty payment which may not exceed €2,500 per day when the author of the breach has not complied with its prescriptions under the end of the period set by a formal notice.
“III. – The amount of the penalty pronounced for the breaches mentioned in 9°, 14°, 15°, 16° and 17° of article L. 5461-9 and in 8°, 11°, 12° and 13° of Article L. 5462-8 may not exceed €150,000 for a natural person and 10% of the turnover achieved during the last closed financial year, within the limit of one million euros, for a legal person .
“The amount of the penalty pronounced for the breaches mentioned in 1° to 8°, 10° to 13° and 18° to 21° of article L. 5461-9 and in 1° to 7°, 9°, 10 ° and 14° to 17° of article L. 5462-8 may not exceed €150,000 for a natural person and 30% of the turnover achieved during the last closed financial year for the product or group of products concerned, within the limit of one million euros, for a legal entity.
“In the event of finding of one of the breaches mentioned in 11°, 12° and 13° of article L. 5461-9 and in 9° and 10° of article L. 5462-8, the authority administrative body in charge of competition and consumption may pronounce a ban on the concerned by the breach, when the author of the breach has not complied with its prescriptions at the end of the period set by a formal notice.
“IV. – The administrative authority responsible for competition and consumer affairs may decide to publish the financial penalty decisions pronounced under I of this article on its website.
« Art. L.5473-2. – When a financial penalty imposed under this chapter is likely to be combined with a criminal fine imposed for the same facts on the author of the breach, the total amount of the fines and financial penalties imposed does not exceed the legal maximum on higher.
« Art. L.5473-3. – The same person cannot be the subject, for the same facts, of a sanction procedure initiated by the National Agency for the Safety of Medicines and Health Products on the basis of the provisions of Article L. 5471- 1 and by the administrative authority responsible for competition and consumption on the basis of those of Article L. 5473-1. To this end, the two authorities exchange the necessary information before the opening of any procedure. » ;
10° In the second paragraph of Article L. 6111-2, the word: “medical” is replaced by the words: “mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017”.
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