Ing, Vangelis Tavandzis, State Institute for Drugs Control, Prague, CZ

 

Currently, the main laws regulating the area of medical devices are as follows:

1) Czech Act no. 22/1997 Coll., on Technical Requirements for Products, as amended;

2) Czech Act no. 123/2000 Coll., on Medical Devices, as amended.

ad1) Act no. 22/1997 Coll., on Technical Requirements for Products, as amended

There are three Government regulations laying down detailed rules for the implementation of Act no.22/97 Coll., and specifying technical requirements for medical devices, in particular:

C conformity assessment procedures to be followed in order to obtain CE marking

C marking with CE Mark

C role of the notified body who carries out conformity assessment

C role of the manufacturer or his authorised representative

C classification of MDs into classes according to risks they present to users, patients and third persons

Below is a list of relevant government regulations¹:

a) Government Regulation no. 336/2004 Coll., laying down technical requirements for medical devices

b) Government Regulation no. 154/2004 Sb., laying down technical requirements for active implantable medical devices

c) Government Regulation no.453/2004 Coll., laying down technical requirements for in vitro diagnostic medical devices

If a manufacturer or his authorised representative wishes to place on the Czech market a medical device after 1^st May 2004, such device must bear the CE marking on the label and instructions for use.

CE Mark:

Class I- non-sterile/non-measuring

Other classes i.e. Class I-sterile/ measuring, Classes IIa, IIb and III, must always bear the CE Mark including a four-digit identification number of the Notified Body who carried out conformity assessment.

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Note:

In the case that a manufacturer or his authorised representative decides to make use of transitional provisions laid down by the above mentioned government regulations, he can place on the market devices following transitional conditions pursuant to:

a) Article 17 (3) GR no.336/04 Coll.,

b) Article 17 (3) GR no. 154/2004 Coll.,

c) Article 16 (1) and (3) GR no.453/04 Coll.

ad2) Act no.123/2000 Coll., on Medical Devices, as amended

Czech Law no.123/2000 Coll., on Medical Devices (as amended) lays down particularly obligations and responsibilities of:

1) healthcare providers

2) State Institute for Drug Control

3) manufacturers or their authorised representatives

4) servicing organizations

The Law further lays down conditions for

1) conduct of clinical evaluation or clinical trials of medical devices (Art. 8 and related articles)

2) use of the Czech Instructions for use (Art. 20)

3) information for users (Art. 21)

4) training (Art. 22)

5) cleaning and disinfections of medical devices (Art. 25)

6) maintenance and servicing of medical devices (Art. §28)

7) keeping records on medical devices (Art. 30)

8) reporting of adverse incidents (Art. 32)

9) inspections of healthcare providers performed by SUKL (Art. 40 and related articles)

10) penalties (Art. 46)

11) transitional provisions applicable to medical devices put into operation before 1 January 1991 and in the period from 1 January 1991 to 31 December 1999 (Art. 52).

The transitional provisions set out in Article 52 are aimed at verification of the present status of properties and characteristics of medical devices (it concerns medical devices in higher risk classes IIb and III) to demonstrate their compliance with technical regulations and/or technical documents and technical standards used in their manufacture, by means of control of records kept by persons registered in accordance with Article 31 or persons with appropriate accreditation.

The State Institute for Drug Control has issued detailed information on responsibilities set out in Article 52 in relation to healthcare providers and a seminar was held to provide information on this issue.

Both the information and seminar presentation (in the Czech language) are available at SUKL website - see www.sukl.cz – Information:

C Information on requirements set out in Article 52 of Act no. 123/2000 Coll. (as amended) concerning medical devices put into operation before the end of 1999

C Czech Act no. 123/00 Coll., on Medical Devices (as amended)concerning obligations of health care providers

C Information on readiness to comply with Article 52 / Informace o pripravenosti na §52

And finally, it should be noted that when obtaining a medical device, a healthcare provider should always require the following information:

- Instructions for use in Czech (wherever practicable);

- CE marking affixed to the medical device or its sterile packaging (where applicable) and in the instructions for use;

- Address of the manufacturer or his authorised representative (for medical devices imported in the EU and intended for distribution in the EU) on the label of the given device;

- In case of any doubts and upon request it is possible to obtain “Declaration of Conformity” issued by the manufacturer or his authorised representative (for medical devices imported in the EU and intended for distribution in the EU).

Note

The CE marking and Declaration of Conformity may refer to or bear a four-digit identification number of any notified body recognized by the EU to perform conformity assessment within the Community, i.e. not necessarily only a Czech notified body as before 1 May 2004.