Since the end of September 2017, Resolution of the Cabinet of Ministers of Ukraine “On Approval of the Technical Regulations for the Restriction of Use of Some Hazardous Substances in Electric and Electronic Equipment” of March 10, 2017, No. 139, entered into force. In particular, suppliers (manufacturers, authorized representatives, importers, sellers) must bring products, documents and marking in compliance with the requirements of the above Technical Regulations (TR) for medical devices (e.g., for in vitro diagnostics) which are both electrical and electronic equipment.

However, a lot of incorrect information (disinformation) appeared in the market on how to understand and comply with the requirements of technical regulations. Improve Medical as a responsible company and a state-designated conformity assessment body analyzed the Resolution. The main conclusions that disclose horror stories from incorrect sources of information are as follows:

1) a wide range of active medical devices (including In vitro) does not fall within the scope of the TR. Therefore, before starting to fulfill the requirements of the TR, it is necessary to carefully check whether it should be done at all;

2) the manufacturer itself shall make the decision on whether to carry out the conformity assessment procedure of medical devices with the TR – there are no previous (before putting into turnover) restrictions on the market supply of products. The controlling bodies can find inconsistencies only during market surveillance;

3) the concept of presumption of conformity is effective for the manufacturers – electrical equipment bearing the appropriate mark as conforming to the technical regulations is considered to be conforming with the TR until the contrary is proved;

4) at the same time, the manufacturer of medical devices, by drawing up a declaration of conformity and making marking, assumes responsibility that the electrical equipment meets the requirements of the TR;

5) the only difficulty that the suppliers may meet is the ability to identify the type of medical electrical equipment correctly (see paragraph 1). As in the case of classification of medical devices by security classes (Technical Regulations No. 753, 754, 755), the process is rather complicated.

Therefore, Improve Medical offers to contact the specialists of our company in cases where suppliers need to identify – whether the medical equipment falls under the general technical regulations on use of hazardous substances in electrical equipment. Below we publish our analysis of technical regulations.

 

Analysis of Technical Regulations No. 139:

On March 10, 2017, Resolution of the Cabinet of Ministers of Ukraine “On Approval of the Technical Regulations for the Restriction of Use of Some Hazardous Substances in Electric and Electronic Equipment”, No. 139, entered into force, which sets requirements for limiting the use of hazardous substances in electrical and electronic equipment. It means, the act applies to the equipment which requires electric current or electromagnetic fields to perform at least one of its functions, and equipment for generation, transmission and measurement of such current or fields designed for use under voltage not exceeding 1000 V for alternating current and 1500 V for direct current.

Pursuant to paragraph 2, the above Technical Regulations applies to electrical and electronic equipment that falls under the categories specified in Annex 1, in particular to medical devices (including medical devices for in vitro diagnostics) that are both electrical and electronic equipment.

However, according to paragraphs 4 to 5 of the Technical Regulations, the Regulations does not apply to:

• active implantable medical devices;

• medical devices and equipment intended for monitoring and control, put into turnover before January 1, 2018;

• medical devices for in vitro diagnostics and industrial devices intended for monitoring and control, put into turnover before July 22, 2018;

• cables or spare parts for repair, reuse or upgrading of functionality or upgrading of production capacities:

1.  medical devices and equipment intended for monitoring and control, put into turnover before January 1, 2018;

2. medical devices for in vitro diagnostics and industrial devices intended for monitoring and control, put into turnover before July 22, 2018.

Paragraph 6 of the TR takes into account restrictions on use of substances specified in paragraphs 7 to 10 of Annex 2, e.g.: Bis (2-ethylhexyl) phthalate (DEHP) 0,1%, butyl benzyl phthalate (BBP) 0,1%, dibutyl phthalate (DBP) 0,1%, Diisobutyl phthalate (DIBP) 0,1%, but does not apply to:

– medical devices (including medical devices for in vitro diagnostics) and monitoring and control devices (including industrial monitoring and control devices), which were put into turnover before July 22, 2021;

– cables or spare parts for repair, reuse or upgrading of functionality or upgrading of production capacities of such electrical and electronic equipment:

1) electrical and electronic equipment falling into categories 1-6, 7 (except toys to the extent limiting the use of substances specified in paragraphs 7 to 8 of Annex 2), 10  and 11, specified in Annex 1, and put into turnover  before July 22, 2019;

2) medical devices (including medical devices for in vitro diagnostics) and devices for monitoring and control (including industrial devices for monitoring and control) put into turnover before July 22, 2021.

Separate paragraphs of the TR specify possible prevention. In particular, paragraph 9 states that: “… electrical and electronic equipment put into turnover, including cables, spare parts for its repair, reuse or upgrading of functionality or upgrading of production capacities, shall not contain substances specified in Annex 2 in concentrations exceeding the maximum permitted values”.

For example:

1. Lead 0.1%

2. Mercury 0.1%

3. Cadmium 0.01%

4. Six-valent chromium 0.1%

5. Polybrominated biphenyls (PBB) 0.1%

Paragraph 10 imposes the restriction specified in paragraph 9 of the Technical Regulations “does not apply to cables and spare parts for its repair, reuse or renewal of functionality or modernization of production capacities of electrical and electronic equipment, for which exceptions from the above restriction are set and which is put into turnover before expiration of the appropriate exception to the extent that the appropriate cables and spare parts refer to the specified exception”.

Paragraph 11 emphasizes that: “… the restriction specified in paragraph 9 of the Technical Regulations does not apply to the exceptions from this restriction listed in Annexes 3 and 4”.

Examples from Annex 3:

1. Mercury in single-coil (compact) fluorescent lamps, the content of which does not exceed (for one burner):

From January 1, 2018, no more than 3.5 mg of mercury per burner can be used

1(c) in general lighting lamps of at least 50 W, but less than 150 W – 5 mg:

until January 1, 2018 – for electrical and electronic equipment falling within categories 1-7 and 10 as defined in Annex 1

until July 22, 2021 – for medical devices and equipment intended for monitoring and control

until July 22, 2023 – for medical devices for in vitro diagnostics

until July 22, 2024 – for industrial devices intended for monitoring and control

6(a). Lead as a doping element in machining steel and galvanized steel with a content of not more than 0.35 percent lead by weight:

until January 1, 2018 – for electrical and electronic equipment falling within categories 1-7 and 10 as defined in Annex 1

until July 22, 2021 – for medical devices and equipment intended for monitoring and control

until July 22, 2023 – for medical devices for in vitro diagnostics.

Example from Annex 4:

1. Lead, cadmium and mercury in ionizing radiation detectors

until July 22, 2021 – for medical devices and devices intended for monitoring and control

until July 22, 2023 – for medical devices for in vitro diagnostics

until July 22, 2024 – for industrial devices intended for monitoring and control.

33. Lead in solders on printed circuit boards used in mobile medical devices of classes IIa and IIb in accordance with the Technical Regulations on Medical Devices, approved by Resolution of the Cabinet of Ministers of Ukraine of October 2, 2013, No. 753 (except portable defibrillators of ambulance). 

Mobile medical devices herein mean medical devices intended for manual transportation, transportation on their own wheels, on a trolley, in a land vehicle, on an aircraft or a ship during operation of such devices and/or between the periods of their work and approved by a designated body in accordance with the Technical Regulations on Medical Devices, approved by the Cabinet of Ministers of Ukraine of October 2, 2013, No. 753, for such application.

The question is what should a manufacturer do to meet the requirements of the regulation? Paragraphs 12 to 22 give a clear answer:

12. When putting electrical and electronic equipment into turnover manufacturers should ensure that it is designed and manufactured in accordance with the requirements specified in paragraphs 9 to 11 of the Technical Regulations.

13. Manufacturers shall make the necessary technical documents and carry out or entrust the authorized representative to carry out the procedure for the internal control of production in accordance with module A defined in the conformity assessment modules used to develop conformity assessment procedures approved by Resolution of the Cabinet of Ministers of Ukraine “On Approval of conformity assessment modules used to develop conformity assessment procedures and the rules for using conformity assessment modules” of January 13, 2016, No. 95 (Official Bulletin of Ukraine, 2016, No. 16, p. 625).

14. If compliance of electrical and electronic equipment with the applicable requirements is proven, manufacturers shall make a declaration of conformity pursuant to Annex 5 and affix the technical regulations conformity mark on the finished product. If other regulatory legal acts define the requirements for application of the same or more stringent conformity assessment procedure, compliance with the requirements of paragraph 9 of the Technical Regulations may be proved within the framework of such procedures. In this case, a single technical documentation may be drawn up.

15. Manufacturers keep technical documentation and declaration of conformity within ten years after putting electrical and electronic equipment into turnover.

16. Manufacturers shall ensure that the procedures necessary to maintain conformity of serial production are applied.

17. Manufacturers shall keep records of electrical and electronic equipment that does not meet the requirements of the Technical Regulations and cases of recall of electrical and electronic equipment, inform distributors thereof.

18. Manufacturers shall ensure identification of products.

19. Manufacturers shall indicate their name, registered commercial name or registered trade mark (mark for goods and services) and contact postal address on electrical and electronic equipment, or, if impossible, on its packaging or in the document accompanying such equipment. The address should indicate a single place where you can contact the manufacturer.

20. Manufacturers who consider or have reason to consider that electrical and electronic equipment they have put into turnover does not comply with the requirements of the Technical Regulations, shall immediately apply restrictive (corrective) measures,

21. Upon a reasoned request from the state market surveillance authority, manufacturers shall provide it with the information and documents necessary for demonstrating conformity.

22. The manufacturer may, designate an authorized representative on the basis of a written proxy. Responsibilities set in paragraph 12 of the Technical Regulations and the obligation to compile technical documents are not included in the subject matter of the proxy received by the authorized representative.

Regarding responsibilities of the authorized representative, the following is indicated:

23. The authorized representative carries out the tasks specified in the proxy received from the manufacturer. The proxy must enable the authorized representative to perform at least the following duties:

keep the declaration of conformity and technical documents for submission to the requests of the state market surveillance bodies within ten years after putting electrical and electronic equipment in turnover;

on a reasoned request from the state market surveillance body, provide such body with all information and documents necessary to demonstrate conformity of electrical and electronic equipment with the Technical Regulations;

upon request of the state market surveillance body, cooperate with it regarding any measures taken to ensure conformity of electrical and electronic equipment covered by the proxy and the Technical Regulations.

Regarding obligations of importers the TR sets forth as follows:

25. Before putting electrical and electronic equipment into turnover, importers shall ensure that the manufacturer had conducted the appropriate conformity assessment procedure and drew up technical documents;

27. Importers shall indicate their name, registered commercial name or registered trademark (mark for goods and services) and contact postal address on electrical and electronic equipment, and if impossible, on its packaging or in the document accompanying such equipment.

28. To ensure compliance with the Technical Regulations, importers shall keep records of electrical and electronic equipment that does not meet the specified requirements, and cases of withdrawal of such equipment and inform distributors thereof.

30. Within a period of ten years after putting electrical and electronic equipment in turnover importers shall keep a copy of the declaration of conformity to provide it to the request of the state market surveillance bodies and ensure the opportunity to provide such bodies with access to technical documens at their request.

31. Upon a reasoned request from the state market surveillance authority, importers shall provide it with the information and documents necessary to verify conformity of electrical and electronic equipment with the Technical Regulations.

The Technical Regulations also includes the list of obligations of distributors of such equipment:

32. During provision of electrical and electronic equipment in the market distributors shall pay due attention to the requirements of the Technical Regulations, in particular verify that such equipment bears the technical regulations conformity mark, is accompanied by the necessary documents drawn up in accordance with the requirements of the legislation on languages, and that the manufacturer and the importer complied with the requirements specified in paragraphs 18, 19 and 27 of thee Technical Regulations, respectively.

33. If distributor considers or has reasons to consider that electrical and electronic equipment does not meet the requirements of paragraphs 9 to 11 of the Technical Regulations, it does not provide such equipment in the market until it is brought in conformity with the specified requirements and informs the manufacturer or importer thereof, as well as the appropriate state market surveillance body.

34. Distributors considering or having reason to consider that electrical and electronic equipment they provided in the market does not meet the requirements of the Technical Regulations, shall assure themselves of taking restrictive (corrective) measures necessary to bring such equipment in compliance with the specified requirements, withdraw it from circulation and/or recall it (as the case may be). Distributors shall immediately inform the appropriate state market surveillance body and provide it with detailed information, in particular regarding non-compliance of such electric and electronic equipment with the requirements of the Technical Regulations and any restrictive (corrective) measures taken.

35. Upon a reasoned request from the state market surveillance authority, distributors shall provide it with the information and documents necessary to verify conformity of electrical and electronic equipment with the requirements of the Technical Regulations. Distributors shall, at the request of the state market surveillance authority, cooperate with it regarding any measures taken to ensure compliance of electrical and electronic equipment provided by them in the market with the requirements of the Technical Regulations.

Cases when obligations of manufacturers are borne by importers and distributors

36. When importer (distributor) puts electrical and electronic equipment in turnover under its name or trademark (mark for goods and services) or modifies electrical and electronic equipment already put into turnover in such a way that it may affect its conformity the applicable requirements, the importer (distributor) shall be considered a manufacturer for the purposes of this Technical Regulations and shall fulfill obligations of the manufacturer set forth in paragraphs 12 to 21 of the Technical Regulations.

Regarding the manufacturer’s responsibility and actions on marking of electrical and electronic equipment, paragraphs 40, 42 to 43 of the TR stipulate as follows:

40. The manufacturer, by drawing up a declaration of conformity, assumes responsibility for compliance of electrical and electronic equipment with the requirements of the Technical Regulation.

42. The mark of conformity with the technical regulations shall be put on the ready-made electrical and electronic equipment or on its technical data plate in such a way that it is visible, legible and indelible. If it is impossible or unreasonable due to the nature of electrical and electronic equipment, the mark of conformity with the technical regulations shall be affixed on packaging and accompanying documents.

43. The mark of conformity with the technical regulations shall be put before putting of electrical and electronic equipment in turnover.

45. Electrical and electronic equipment bearing the mark of conformity with the technical regulations on the basis of presumption of conformity is considered to be in compliance with the requirements of thee Technical Regulations if there is no evidence to the contrary.

Summarizing the above, it becomes clear that the decision on extending the effect of the Technical Regulation on electrical and electronic equipment shall be made by the manufacturer. In cases where it is necessary to identify equipment as falling within the scope of the above TR, the manufacturer or its authorized representative may apply to the conformity assessment body Improve Medical LLC for more detailed information.

Our tel.: +38 044 355-50-30