Information for distributors of medical devices
Definition
According to § 3 (b) Act no. 123/2000 Coll., providing for medical devices and for change of some related acts, as amended (hereinafter referred to as “Medical Devices Act”), and § 2 (g) Act no. 22/1997 Coll., providing for technical requirements on products and for change and addition to some acts, as amended, ‘distributor’ shall mean any person in the supply chain who places the products on the market.
For the purpose of fulfilling of the information duty under § 31 (2) Medical Devices Act ‘distributor’ means the person who places on the market in the Czech Republic a medical device, about which was given information in other Member State of the European Union (and other states according to an international agreement), and/or the person who within the territory of the Czech Republic obtains, stores and provides medical devices for further dealing with them. For given purpose the distribution does not mean provision of medical devices to persons who either further fabricate the medical devices or provide health care by the medical devices according to the Act no. 20/1966, providing for care of the people’s health, as amended.
‘Distributor’ is also a distributor of active implantable medical device or a distributor of in vitro diagnostics.
Information duties
Under § 31 (2) Medical Devices Act distributors shall inform the Ministry of Health of the Czech Republic about their activity via forms set by the Government Regulation (hereinafter referred to as “the information about person’s activity”).
Under § 31 (3) Medical Devices Act distributors shall inform the Ministry of Health of the Czech Republic about any change of information given under § 31 (2) Medical Devices Act within 30 days from the moment of the change (hereinafter referred to as “the change of information”).
Evidence numbers
The new evidence system of persons dealing with medical devices is one of the impacts of amendments of Government Regulations which came in force on 1 April 2011. For the creation of the evidence system the Ministry of Health of the Czech Republic (hereinafter referred to as “the Ministry”) appoints an evidence number to a person having provide or providing the initial information about person’s activity after 16 June 2010. The person shall provide the appointed evidence number in case of any further communication about fulfilling the information duty (principally in case of the change of information).
Codes of internationally recognised nomenclatures of medical devices
Distributors providing the information of person’s activity fill in the forms among others codes of groups of medical devices according to internationally recognised nomenclature of medical devices. Generally distributors shall provide the codes according to the Global Medical Devices Nomenclature (GMDN codes). The only exemption is guaranteed to distributors who place on the market a medical device, which manufacturer or authorised representative is seated in the Member State, whose competent authority does not require GMDN codes. These distributors may provide the codes according to the Universal Medical Devices Nomenclature System (UMDNS codes).
Forms set by Government Regulations
Cut-down of administrative expenditures is a positive impact of amendments of Government Regulations, for the subjects to the information duty are supposed to fulfil this duty primarily via e-mail1) with certified electronic signature. Electronic forms for fulfilling the information duty with detailed instruction are available on the internet sites of the Ministry. If the person filling in and sending the forms is not identical with the distributor the e-mail shall include an electronic copy of power of attorney.
To provide the information about person’s activity a distributor (except of a distributor of active implantable medical device or a distributor of in vitro diagnostics) fills in and sends merely the Form for notification of persons dealing with medical devices according to § 13 (5) Government Regulation no. 336/2004 Coll., as amended by the Government Regulation no. 65/2011 Coll., i. e. the form according to the annex no. 14 to the Government Regulation no. 336/2004 Coll., as amended by the Government Regulation no. 65/2011 Coll.
To provide the information about person’s activity a distributor of active implantable medical device fills in and sends merely the Form for notification of persons dealing with active implantable medical devices according to § 16 (5) Government Regulation no. 154/2004 Coll., as amended by the Government Regulation no. 66/2011 Coll., i. e. the form according to the annex no. 10 to the Government Regulation no. 154/2004 Coll., as amended by the Government Regulation no. 66/2011 Coll.
To provide the information about person’s activity a distributor of in vitro diagnostic fills in and sends merely the Form for notification of persons dealing with in vitro diagnostics according to § 11 (6) Government Regulation no. 453/2004 Coll., as amended by the Government Regulation no. 67/2011 Coll., i. e. the form according to the annex no. 12 to the Government Regulation no. 453/2004 Coll., as amended by the Government Regulation no. 67/2011 Coll.
To provide the change of information a distributor uses the same form as in the aforementioned situations.
Subjects fill in only the above given forms!
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1) send to: mzcr@mzcr.cz, with subject: Fulfilling of the information duty under the Act no. 123/2000 Coll., as amended