Act No. 90 / 2021 Coll.
Act amending Act No. 268 / 2014 Coll., on Medical Devices and amending Act No. 634 / 2004 Coll., on Administrative Charges, as amended, Act No. 634 / 2004 Coll., on Administrative Charges, as amended, and Act No. 40 / 1995 Coll., on Advertising Regulation and amending and supplementing Act No. 468 / 1991 Coll., on Broadcasting, as amended, as amended
Valid
Law
Effective from 26.05.2021
90
THE LAW
of 9 February 2021
amending Act No. 268 / 2014 Coll., on Medical Devices and amending Act No. 634 / 2004 Coll., on Administrative Charges, as amended, Act No. 634 / 2004 Coll., on Administrative Charges, as amended, and Act No. 40 / 1995 Coll., on Advertising Regulation and amending and supplementing Act No. 468 / 1991 Coll., on the Operation of Radio and Television Broadcasting, as amended
Parliament has decided on this law of the Czech Republic:
Amendment of the Administrative Charges Act
Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 2011, Act No. 2011, Act No. 2011, Act No. 13 / 2011, Act No. 13 / 2011, Act No. 2011, Act No. 2011 / 2011, Act No. 2011, Act No. 2011, Act No. 2011 / 2011 / 2011, Act No. 2011, Act No. 2011, Act No. 2011 / 2011, Act No. 2011, Act No. 2011, Act No. 13 / 2011, Act No. 2011, Act No. 2011, Act No. 2011, Act No. 2011 / 2011, Act No. 2011 / 2011, Act No. 2011, Act No. 2011, Act No. 2011, Act No. 2011, Act No. 2011, Act No. 2011 / 2011, Act No. 2011, Act No. 2011, Act No. 2011, Act No. 2011, Act No. 2011, Act No. No. 2011, No
1. In item 97 (3):
"3. Acceptance
| a) | žádosti o notifikaci nebo prodloužení notifikace sériově vyráběného diagnostického zdravotnického prostředku in vitro nebo příslušenství diagnostického zdravotnického prostředku in vitro uváděného na trh výrobcem nebo zplnomocněným zástupcem | Kč 500 |
| b) | ohlášení činnosti výrobce sériově vyráběných diagnostických zdravotnických prostředků in vitro | Kč 3 000 |
| c) | ohlášení činnosti zplnomocněného zástupce podle zákona o diagnostických zdravotnických prostředcích in vitro | Kč 3 000 |
| d) | ohlášení činnosti distributora diagnostických zdravotnických prostředků in vitro | Kč 3 000 |
| e) | ohlášení činnosti osoby provádějící servis diagnostických zdravotnických prostředků in vitro | Kč 3 000 |
| f) | ohlášení činnosti dovozce diagnostických zdravotnických prostředků in vitro | Kč 3 000 |
| g) | žádosti o vystavení certifikátu volného prodeje na diagnostický zdravotnický prostředek in vitro | Kč 1 000“. |
2. in entry 97, the following points 4 and 5 are added:
| „4. | Ověření údajů podle čl. 31 bodu 1 nařízení Evropského parlamentu a Rady (EU) 2017/745 ze dne 5. dubna 2017 o zdravotnických prostředcích, změně směrnice 2001/83/ES, nařízení (ES) č. 178/2002 a nařízení (ES) č. 1223/2009 a o zrušení směrnic Rady 90/385/EHS a 93/42/EHS (dále jen „nařízení o zdravotnických prostředcích“) a přidělení jediného registračního čísla podle čl. 31 bodu 2 nařízení o zdravotnických prostředcích výrobci, zplnomocněnému zástupci nebo dovozci | Kč 3 000 |
5. Adoption
| a) | ohlášení o zahájení činnosti výrobce zdravotnických prostředků na zakázku | Kč 3 000 |
| b) | ohlášení o zahájení činnosti distributora zdravotnických prostředků | Kč 3 000 |
| c) | ohlášení o zahájení činnosti osoby provádějící servis zdravotnických prostředků | Kč 3 000 |
| d) | žádosti o obnovení zneplatněných údajů ohlášené osoby v Informačním systému zdravotnických prostředků | Kč 1 500 |
| e) | žádosti o povolení klinické zkoušky zdravotnického prostředku | Kč 1 000 |
| f) | žádosti o vystavení certifikátu o volném prodeji zdravotnického prostředku | Kč 1 000“. |
Amendment to the Advertising Regulation Act
Act No. 40 / 1995 Coll., on the regulation of advertising and amending and supplementing Act No. 468 / 1991 Coll., on the operation of radio and television broadcasting, as amended, as amended, Act No. 258 / 2000 Coll., Act No. 231 / 2001 Coll., Act No. 245 / 2001 Coll., Act No. 135 / 2002 Coll., Act No. 320 / 2002 Coll., Act No. 132 / 2003 Coll., Act No. 132 / 2004 Coll., Act No. 28 / 2011 Coll., Act No. 326 / 2004 Coll., Act No. 480 / 2004 Coll., Act No. 36 / 2008 Coll., Act No. 296 / 2008 Coll., Act No. 25 / 2006 Coll., Act No. 109 / 2007 Coll., Act No. 160 / 2007 Coll.
1. In Article 1 (1), the words "to medical devices and in vitro diagnostic medical devices' shall be inserted after the words" veterinary medicinal products'.
2. At the end of footnote 1, the sentence "Article 7 of Regulation (EU) 2017 / 745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001 / 83 / EC, Regulation (EC) No 178 / 2002 and Regulation (EC) No 1223 / 2009 and repealing Council Directives 90 / 385 / EEC and 93 / 42 / EEC is added. '.
3.
Comparative advertising for medicinal products intended for human use (hereinafter referred to as "medicinal products for human use"), medical services, medical devices or in vitro diagnostic medical devices shall be permitted, subject to the conditions laid down in the Civil Code, if it is aimed at persons authorised to prescribe or supply such medicinal products, medical devices or in vitro diagnostic medical devices (hereinafter referred to as "experts") or to provide such medical services. ';
4. After § 5j, the following § 5k to 5m is inserted:
In vitro medical devices and diagnostic medical devices
(1) All forms of information, surveys or incentives to promote prescription, dispensation, sale or use of medical devices and in vitro diagnostic medical devices shall also be considered as advertising for in vitro medical devices and diagnostic medical devices. These are in particular:
(a) visits by representatives with medical devices and in vitro diagnostic medical devices to persons authorised to prescribe or issue them;
(b) the supply of samples of medical devices and in vitro diagnostic medical devices;
(c) support for the prescription, supply or sale of in vitro medical devices and diagnostic medical devices by means of gifts, consumer competition and offer or promise of any benefit or financial or material remuneration;
(d) sponsoring meetings held to promote the prescription, sale, supply or use of in vitro medical devices and diagnostic medical devices and attended by experts; or
(e) sponsorship of scientific congresses and other similar meetings involving experts and reimbursement of transport and accommodation costs associated with their participation.
(2) The provisions of this Act do not apply to:
(a) correspondence necessary to answer specific questions about a particular medical device or in vitro diagnostic medical device and any accompanying materials of a non-advertising nature;
(b) sales catalogues and price lists, unless they contain a description of the properties of medical devices and in vitro diagnostic medical devices;
(c) data on human health or diseases, if they contain no reference, even indirectly, to a medical device or in vitro diagnostic medical device.
(3) Only a medical device that can be placed on the market in accordance with Regulation (EU) 2017 / 74542 of the European Parliament and of the Council or an in vitro diagnostic medical device that can be placed on the market in Vitro43 shall be the subject of advertising unless otherwise specified.
(4) A medical device which does not meet the conditions for placing on the market under Regulation (EU) 2017 / 74542 of the European Parliament and of the Council may be presented or presented only at fairs, exhibitions and demonstrations or similar events, provided that it is labelled in accordance with Regulation (EU) 2017 / 74544 of the European Parliament and of the Council.
(5) In vitro diagnostic medical devices which do not meet the conditions for placing on the market may be presented or presented only at trade fairs, exhibitions and demonstrations or similar events, provided that they are visibly indicated that they cannot be placed on the market or put into service until they have been brought into conformity. Such in vitro diagnostic medical devices shall not be used on samples originating from participants in the action in accordance with the first sentence.
(6) The advertising of in vitro diagnostic medical devices shall not contain texts, names, trade marks, pictures and figurative or other symbols which could mislead the patient as regards the intended purpose, safety and performance of the in vitro diagnostic medical device, by:
(a) indicate functions or characteristics which are not in vitro diagnostic medical devices;
(b) give false insight into treatment or diagnosis, functions or properties which are not in vitro diagnostic medical devices;
(c) not inform the user or the patient of the likely risk associated with the use of an in vitro diagnostic medical device in accordance with its intended purpose; or
(d) propose different ways of using a diagnostic medical device in vitro than those specified in the intended purpose.
(7) Advertising of in vitro medical devices and diagnostic medical devices covered in full or in part by public health insurance in the form of consumer competition, consisting of a number of prescribed, issued or used devices, is prohibited.
(8) Advertising of in vitro medical devices and diagnostic medical devices must not in any way refer to specific public authorities.
Advertising of in vitro medical devices and diagnostic medical devices intended for the general public
(1) The object of advertising to the general public shall not be a medical device and an in vitro diagnostic medical device which, according to the manufacturer's instructions, is intended only for use by a health professional and a medical device and an in vitro diagnostic medical device which may only be issued for a voucher or a requisition issued by a doctor under other legislation.
(2) The provision of samples of in vitro medical devices and diagnostic medical devices referred to in paragraph 1 to the general public shall be prohibited.
(3) Advertising of in vitro medical devices and diagnostic medical devices to the general public must:
(a) be formulated to show that the product is an in vitro medical device or diagnostic medical device;
(b) include the trade name of the medical device and the in vitro diagnostic medical device;
(c) contain the intended purpose of the medical device and the in vitro diagnostic medical device; and
(d) contain a clear, well-readable call for careful reading of the instructions for use of the medical device and the in vitro diagnostic medical device and information relating to its safe use, provided that the medical device and the in vitro diagnostic medical device are accompanied by another legislation.
(4) Advertising of a medical device and an in vitro diagnostic medical device to the general public must not
(a) to give the impression that medical advice, medical intervention or treatment are not necessary, in particular by offering a diagnosis or by offering a remote treatment,
(b) indicate that the clinical efficacy of a medical device and an in vitro diagnostic medical device is guaranteed, is better or equivalent to that of another treatment or other medical device and an in vitro diagnostic medical device, or that the use of a medical device and an in vitro diagnostic medical device is not associated with risks;
(c) indicate that non-use of a medical device and an in vitro diagnostic medical device may adversely affect the health of persons;
(d) be targeted exclusively at persons under the age of 15;
(e) recommend a medical device and an in vitro diagnostic medical device with reference to the advice of scientists, medical experts or persons who are not, but which, because of their actual or anticipated social status, could support the use of a medical device and an in vitro diagnostic medical device;
(f) refer to the conduct of clinical trials or other processes which are a condition for placing a medical device and an in vitro diagnostic medical device on the market,
(g) indicate that the safety or efficacy of the medical device and the in vitro diagnostic medical device is only guaranteed by the fact that it is of natural origin;
(h) a description or detailed description of the particular course of a particular case, leading to a possible misdiagnosis;
(i) to point out in an inappropriate, excessive or misleading way the possibility of recovery;
(j) use an inappropriate, excessive or misleading way of depicting changes in the human body caused by disease or injury or by the action of a medical device and a diagnostic medical device in vitro on the human body or parts thereof.
(5) Where advertising aimed at the general public is intended as a reminder of a medical device and an in vitro diagnostic medical device, it shall not contain data other than the commercial name of the medical device and the in vitro diagnostic medical device or, where appropriate, a trade mark.
Advertising of in vitro medical devices and diagnostic medical devices
(1) Advertising of medical devices and in vitro diagnostic medical devices to professionals can only be disseminated by means of means of communication intended primarily for such professionals, in particular in professional publications, professional press, professional audiovisual programmes, and must include:
(a) sufficient, verifiable and objective data to enable experts to establish their own opinion on the clinical benefits of a particular medical device and an in vitro diagnostic medical device; data taken from professional publications or from professional printing must be reproduced accurately and their source must be indicated;
(b) the basic information contained in the instructions for use of the medical device and the in vitro diagnostic medical device if it must be attached to the device.
(2) In the context of advertising on medical devices and in vitro diagnostic medical devices aimed at professionals, it shall be prohibited to offer, promise or provide gifts or other benefits, unless they are of negligible value and relate to professional activities carried out by them. This does not apply to the provision of in vitro samples of a medical device and diagnostic medical device in the amount needed to test a medical device and an in vitro diagnostic medical device in accordance with the intended purpose of use. A sample of a medical device and an in vitro diagnostic medical device thus provided shall be visibly marked with the words "Non-sales sample 'or" Free sample'.
(3) When sponsoring meetings and scientific congresses pursuant to § 5k (1) (d) and (e), the sponsor or organiser of the free-to-charge entertainment, accommodation and transport shall be proportionate to the purpose of the meeting, taking into account the purpose of the meeting and shall not be extended to persons other than experts; in that case, the scope of the catering, accommodation and transport provided shall not be subject to the prohibition laid down in paragraph 2.
(4) Experts may not, in the context of advertising on medical devices and in vitro diagnostic medical devices, seek or receive benefits prohibited under paragraph 2 or which are contrary to paragraph 3.
(5) Where advertising aimed at professionals is intended as a reminder of a medical device and an in vitro diagnostic medical device, it shall not contain data other than the trade name of the medical device and the in vitro diagnostic medical device or, where appropriate, a trade mark.
(42) Regulation (EU) 2017 / 745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001 / 83 / EC, Regulation (EC) No 178 / 2002 and Regulation (EC) No 1223 / 2009 and repealing Council Directives 90 / 385 / EEC and 93 / 42 / EEC.
43) Act No. 268 / 2014 Coll., on in vitro diagnostic medical devices, as amended. Directive 98 / 79 / EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, as amended.
44) Article 21 (3) of Regulation (EU) 2017 / 745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001 / 83 / EC, Regulation (EC) No 178 / 2002 and Regulation (EC) No 1223 / 2009 and repealing Council Directives 90 / 385 / EEC and 93 / 42 / EEC. '
5. After § 5m, the following § 5n is inserted:
Advertising of health-oriented products
(1) Advertising of a non-medicinal product or medical product or in vitro diagnostic medical device is prohibited indicating that the product is a medicinal product, a medical product or an in vitro diagnostic medical device.
(2) Advertising of non-medicinal products, medical devices, in vitro diagnostic medical devices or any other product for which this Law provides otherwise may not:
(a) indicate that the use of the product will improve or maintain the health of the user;
(b) indicate that non-use of the product may adversely affect the health of persons;
(c) recommend a product with reference to the recommendations of scientists, health professionals or persons who are not, but who, because of their actual or anticipated social position, might support the use of the product. "
6. In Article 6b (1), the third sentence is deleted.
7. In Article 7 (b), the words "to medical devices and in vitro diagnostic medical devices' shall be inserted after the words" tissues and cells' and, at the end of the text of the letter, the comma shall be replaced by a semicolon and the words "the State Institute for Drug Control shall be the authority responsible for supervising compliance with Article 7 of Regulation (EU) 2017 / 74542 of the European Parliament and of the Council ';
8. In Article 8 (1), the words "or, in the case of medical devices and in vitro diagnostic medical devices as referred to in Article 5l (2) 'shall be added at the end of the text of point (d).
9. in Article 8 (1) (i):
"(i) in contravention of Article 5b (1) or Article 5m (1), it shall, by means of means of communication, disseminate advertising to medicinal products for human use or to medical devices or in vitro diagnostic medical devices which are aimed at professionals without being intended primarily for professionals covered by the advertising of the type of product concerned,";
10. the words "or § 5m (2)" shall be added at the end of the text of point (j).
11. in Paragraph 8 (1), the comma at the end of point (n) shall be replaced by a dot and point (o) shall be deleted;
12. in § 8 (2) (a) and § 8a (2) (a), the words "or § 3 (1)" shall be replaced by "§ 3 (1) or § 5n (1)";
13. in Article 8 (2) (b), the words "or § 5j" shall be replaced by the words ", § 5j, § 5k (3), (4), (5), (6), (7) or (8), § 5l (1), (3), (4) or (5), or in Regulation (EU) 2017 / 74542 of the European Parliament and of the Council";
14. in Article 8 (3) (d), the words "or 5i" shall be replaced by "§ 5i, § 5k (3), (4), (5), (6), (7) or (8), § 5l (1), (3), (4) or (5), or § 5n (2) or in Regulation (EU) 2017 / 74542 of the European Parliament and of the Council";
15. in Article 8 (4), the text "or § 5m (2)" shall be inserted after the text "§ 5b (5)" and the text "or § 5m (3)" shall be inserted after the text "§ 5b (5)."
16. in Article 8 (5) (b), "(a), (m) or (o)" shall be replaced by "(a) or (m)";
17. in Paragraph 8a (1), the words "or, in the case of medical devices and in vitro diagnostic medical devices, in accordance with § 5l (2)," shall be added at the end of the text of point (e).
18. in Paragraph 8a (1) (f):
"(f) in contravention of Article 5b (1) or Article 5m (1), advertising for medicinal products for human use or medical devices or in vitro diagnostic medical devices shall be disseminated by means of means of communication, which shall be targeted at professionals without being intended primarily for professionals covered by advertising for the type of product concerned,";
19. in § 8a (1), the text "or § 5m (2)" shall be added at the end of the text (h).
20. In Paragraph 8a (1), the comma at the end of point (q) is replaced by a dot and point (r) is deleted.
21. in § 8a (2) (d), the words "5i or § 5j" shall be replaced by the words "§ 5i, 5j, § 5k (3), (4), (5), (6), (7) or (8), § 5l (1), (4) or § 5n (2) or in Regulation (EU) 2017 / 74542 of the European Parliament and of the Council";
22. in Article 8a (3) (d), "5h or 5i" is replaced by "§ 5h, 5i, § 5k (3), (4), (5), (6), (7) or (8), § 5l (1), (4) or (5), or § 5n (2) or in Regulation (EU) 2017 / 74542 of the European Parliament and of the Council."
23. in § 8a (4), the words "or § 5m (2)" shall be added at the end of the text of point (a).
24. in § 8a (4), the words "or § 5m (3)" shall be added at the end of the text of point (b).
25. in Article 8a (4) (c), the words "medicinal products for human use" shall be deleted; the words "or § 5m (2)" shall be inserted after the words "§ 5b (5)" shall be inserted after the words "or § 5m (3)."
26. in § 8a (5) (a), "(a), (p) or (r)" shall be replaced by "(a) or (p)";
Transitional provision
Advertising of in vitro medical devices and diagnostic medical devices created or disseminated under contracts concluded before the date of entry into force of this Act shall be assessed in accordance with Act No. 40 / 1995 Coll., as effective before the date of entry into force of this Act.
EFFECTIVE
This Act shall take effect on 26 May 2021.
Vondracek v. r.
Zeman v. r.
Babiš v. r.
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Regulation Information
| Citation | Act No. 90 / 2021 Coll., amending Act No. 268 / 2014 Coll., on Medical Devices and amending Act No. 634 / 2004 Coll., on Administrative Charges, as amended, Act No. 634 / 2004 Coll., on Administrative Charges, as amended, and Act No. 40 / 1995 Coll., on Advertising Regulation and amending and supplementing Act No. 468 / 1991 Coll., on Broadcasting, as amended, as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 01.03.2021 |
|---|---|
| Effective from | 26.05.2021 |
| Effective until | - |
| Status | Valid |
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