Právní předpis byl sestaven k datu 30.03.2015.
Zobrazené znění právního předpisu je účinné od 01.10.2003 do 30.03.2015.
Vyhláška, kterou se mění vyhláška č. 501/2000 Sb., kterou se stanoví formy, způsoby ohlašování nežádoucích příhod zdravotnických prostředků, jejich evidování, šetření a vyhodnocování, dokumentace a její uchovávání a následné sledování s cílem předcházení vzniku nežádoucích příhod, zejména jejich opakování (vyhláška o nežádoucích příhodách zdravotnických prostředků)
304/2003 Sb.
304
XXXXXXXX
xx xxx 3. xxxx 2003,
xxxxxx xx mění xxxxxxxx x. 501/2000 Xx., xxxxxx se xxxxxxx xxxxx, xxxxxxx ohlašování xxxxxxxxxxx xxxxxx xxxxxxxxxxxxxx xxxxxxxxxx, jejich xxxxxxxxx, xxxxxxx a xxxxxxxxxxxxx, xxxxxxxxxxx x xxxx xxxxxxxxxx x xxxxxxxx xxxxxxxxx x xxxxx xxxxxxxxxxx xxxxxx xxxxxxxxxxx xxxxxx, xxxxxxx xxxxxx xxxxxxxxx (xxxxxxxx x xxxxxxxxxxx xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx)
Ministerstvo xxxxxxxxxxxxx xxxxxxx xxxxx §34 xxxxxx x. 123/2000 Sb., o xxxxxxxxxxxxxx prostředcích x x změně xxxxxxxxxxxxx xxxxxx:
Xx. X
Xxxxxxx x. 1 x 2 x xxxxxxxx č. 501/2000 Sb., xxxxxx xx stanoví formy, xxxxxxx xxxxxxxxxx xxxxxxxxxxx xxxxxx xxxxxxxxxxxxxx xxxxxxxxxx, xxxxxx evidování, šetření x xxxxxxxxxxxxx, dokumentace x xxxx xxxxxxxxxx x následné sledování x xxxxx xxxxxxxxxxx xxxxxx xxxxxxxxxxx xxxxxx, xxxxxxx xxxxxx xxxxxxxxx (xxxxxxxx o xxxxxxxxxxx xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx), xxxxx:
"Xxxxxxx x. 1 x xxxxxxxx x. 501/2000 Xx.
Xxxxxxxx X
pro xxxxx xxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx
Xxxxxxxx Initiral Xxxxxx Xxxx
Xxxxxx k xxxxxxx xxxxxxxxx příhody
Xxxxx on xxxxxxxxx xxxxxxxx
Hlášení xxxx xxx xxxxxx xxxxxxxxxx, x xxxx xxxxxx x xxxxxxxxx všechny xxxxxxxx xxxxxxxxx.
Xxx xxxxxx xxxxxx be xxxx as xxxx xx xxxxxxxx even xx xxx xxx xxx information xxxxxxxxx xxx the xxxxxxxxxx xx the xxxx xx xxxxxxxxx.
2100 | Xxxxxxxxx xxxx xxxxxxxxxxx xxxxxxx nežádoucí příhody / Xxxxxxxxxx detexting xxxxxxx xxxxxxxx Kód xxxxxxxxxxx úřadu / Xxxx of xxxxxxxxx xxxxxxxxx CZ/CA02 | ||
2110 | Xxxxx příslušného xxxxx / Xxxx of xxxxxxxxx xxxxxxxxx Státní xxxxx pro xxxxxxxx xxxxx (xxxx xxx „XXXX“) | ||
2120 | Ulice, xxxxx xxxx x/xxxx xxxxxxxx schránky / Xxxxxx, xxxxx xxxxxx xxx/xx PO xxx Xxxxxxxxx 48 | ||
2130 | XXX / Xxxxxx xxxx 100 41 | 2140 | Xxxx / Xxxx Xxxxx 10 |
2150 | Xxxxxxx / Xxxxxxxxx xxxxxx 272&xxxx;185&xxxx;780, 272&xxxx;185&xxxx;705 | 2160 | Xxx / Xxx xxxxxx 272&xxxx;185&xxxx;764 |
2170 | X-Xxxx xxxx@xxxx.xx | 2180 | Stát / Xxxxxxx XX |
2190 | Xxxxxxx xxx XXXX xx xxxxxxxx, který xxxxx nežádoucí xxxxxxx / Report xx XXXX xx subject xxxxxxxxxx xxxxxxx xxxxxxxx Xxxxx xxxxxxxx, xxxxx xxxxxx zprávu / Xxxx xx subject xxxxxxxxxx xxxxxx | ||
2195 | Xxx subjektu / Xxxx xx xxxxxxx1) | ||
2200 | Výrobce / Xxxxxxxxxxxx Uživatel / User Xxxxxxxxxxxx xxxxxxxx / Xxxxxxxxxx xxxxxxxxxxxxxx2) Xxxxxxx / Other Xxxxxxx / Xxxxxxxx | ||
2210 | Xxxxx, xxxxx xxxx x/xxxx xxxxxxxx xxxxxxxx / Street, xxxxx xxxxxx xxx/xx XX box | ||
2220 | XXX / Xxxxxx xxxx | 2230 | Xxxx / Xxxx |
2240 | Xxx xxxxx / Xxxxxxx xxxx3) | 2250 | Xxx xxxxx / Xxxxxx xxxx4) |
2260 | Xxxxx kontaktní xxxxx / Xxxx xx xxxxxxx xxxxxx5) | ||
2270 | Telefon / Xxxxxxxxx number | 2280 | Xxx / Xxx xxxxxx |
2290 | X-Xxxx | 2230 | Xxxxx xxxxxxx / Xxxx xx xxxxxx6) |
2305 | Číslo xxxxxxxxx xxxxxxx (přiděluje XXXX) Xxxxxxxx xxxxxx (xxxxxxxxxx xxxxxx assigned xx XXXX) CZ/CA02/..... | ||
2310 | Xxxxxxxxxxxx xxxxxxxxxx / Xxxxxxx xxxxxx Xxxxx xxxxxxxxxxxxxx xxxxxxxxxx / Xxxxxxxxxx name xx xxxxxxx xxxxxx |
2320 | Xxx skupiny zdravotnického xxxxxxxxxx podle XXXXX / GMDN7) XXXX / GMDN xxxx xx xxxxxxx xxxxxx |
2330 | Název xxxxxxx xxxxxxxxxxxxxx prostředku xxxxx xxxxx XXXXX / XXXX (např. xxxxxxxxxxxxxxxxx, xxxxxx xxxxxxxxxx)7) UMDNS / XXXX designation xx xxxxxxx xxxxxx xx Czech (x.x. Xxxxxxxxxx, Cardiac, Xxxxxxxx Xxxxxxxxxxx) |
2335 | Kód xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx8) Xxxxxxxx xx xxxxxxx xxxxxx |
2340 | Xxxxxxxx xxxx xxxxxxxxxxx xxxxx xxxxxxxxxxxxxx prostředku / Xxxxx xx xxxxxxxxx xxxxxx |
2350 | Xxxxx(x) xxxxx xxxx xxxxx xxxxxxxxxxxxxx prostředku Xxxxxx xxxxxx(x) xx lot xxxxxx(x) |
2360 | Xxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx / xxxxxxxxxxxxx (xxxxxxxx xx xxxxxxxx)9) Xxxxxxxxxx medical xxxxxxx / xxxxxxxxxxx (if xxxxxxxxxx) |
2370 | Verze xxxxxxxxxxxx xxxxxxxx (xxxxxxxx xx xxxxxxxx)9) Xxxxxxxx xxxxxxx (xx xxxxxxxxxx) |
2380 | Xxxxxxx / Manufacturer Xxx xxxxxxx / Xxxx of manufacturer1) |
2390 | Xxxxx xxxxxxx / Name of xxxxxxxxxxxx5) |
2400 | Xxxxxxxxxxxxx xxxxx autorizované xxxxx, xxxxx shodu xxxxxxxxx. Xxxxxxxxxxxxxx xxxxxx of Xxxxxxxx Xxxx xxxxxxxx xx xxxxxxxxxx xxxxxxxxxx. XX/XX...... |
2410 | Xxxxxx tento xxxxxxx xxx xxxxx xxxxxxxxx xxxxxxx zdravotnického xxxxxxxxxx stejného typu? Xxx xxx reporting xxxx previously xxxxxxxx xxxxxxxx involving this xxxxxxx xxxxxx? xxx / yes xx / xx |
2420 | Xxxxx xxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx / Xxxx xx xxxxxx xx xxxxxxx xxxxxxxx6) |
2430 | Xxxxxxxx xxx, xxx do xxxxx xxxx (ze xxxx XX, xxx xx xxxxxxxxxxxx xxxxxxxxxx prodává)2) Xx xxx, xx xxxxx country (xxxxx XXX countries xxxxx xxx xxxxxxx xxxxxx xx on xxxx) XX XX DE XX XX XX XX XX GR XX XX XX XX XX NL XX XX XX |
2440 | Xxxxxxx xxxxxxx / Xxxxxx to xxxxxxxxxxxx Xxxxxxx xxxxxxx xxxxxx (xxxxxxxx, xxxxxxxxx osoba, xxxx xxxxx):10) Xxxxxx xx xxxxxxxxxxxx xx (xxxx, contact xxxxxx xx xxxxx xxxxxx): |
2450 | Ulice, xxxxx xxxx x/xxxx xxxxx xxxxxxxx xxxxxxxx / Xxxxxx, xxxxx xxxxxx xxx/xx XX xxx |
2460 | PSČ / Xxxxxx xxxx | 2470 | Xxxx / City |
2480 | Xxx xxxxx / Xxxxxxx3) | 2490 | Xxxx / Xxxxxx xxxx4) |
2500 | Xxxxxxx / Xxxxxxxxx number | 2510 | Fax / Xxx xxxxxx |
2520 | X-Xxxx | ||
2530 | Xxxxx xxxxxxx / Xxxx xx xxxxxx6) | ||
2540 | Nežádoucí příhoda / Xxxxxxxx Xxxxx xxxxxxxxx xxxxxxx / Xxxx xx incident6) |
2550 | Xxxxx xxxxxxxxx xxxxxxx / Xxxxx xx xxxxxxxx |
2560 | Xxxxx xxxxxxxxx xxxxxxx / Xxxxxxxxxxx of incident9) |
2570 | Xxxxxxxx xxxxxxxxx xxxxxxx (xxxx. xxxxx, xxxxxxxxx xxxxxx ...) Outcome xx the incident (x.x. death, xxxxxxxxxxxxx xx xxxxxx ...) |
2580 | Xxxxxxxxx xxxxxxxxx xxxxxxx / Xxxxxxxxxxxx´x xxxxxxxxxx comment 9) |
2590 | Xxxxxxxxxxxxx datum xxx xxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxx / Xxxxxxxx xxxx xx xxx xxxxxxxx xxxxxx-xx xxxxxx6) |
2600 | Xxxxxxxxx xxxxxxxx opatření, xxxxxxxx bylo přijato9) Xxxxxxx corrective action (xx xxx) |
2610 | Časový xxxxxx nápravných opatření / Xxxxxxx xxxxxxxx |
2620 | Xxxxx x xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxxx / xxxxxxxxxxxxxx x Xxxxx xxxxxxxxx Information xx xxxxxxx devices xxxx / xxxxxxxxxxx xx the Xxxxx Xxxxxxxx Xxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Custom-made xxxxxx ano/yes xx/xx |
2630 | Xxxx xxxxxxx xxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx Part of x xxxxxx or x xxxxxxxxx xxxx xxx/xxx xx/xx |
2640 | Zdravotnický xxxxxxxxxx s měřící xxxxxx Xxxxxxx xxxxxx with xxxxxxxxx xxxxxxxx xxx/xxx xx/xx |
2650 | Zdravotnický xxxxxxxxxx, na xxxxx xx xxxxxxxx x xxxxx xxxxxxxx xx xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxx x xxxxxxxxxxxx xxxxxx x xxxxxx xxxxxxxx, xxxxxxx se xxxxxxx11) xxx/xxx ne/no Xxxxxxx xxxxxx according xx the Xxx xx Xxxxxxxxx Xxxxxxxxxxx xx Xxxxxxx Xxxxxx |
2660 | Výjimka xxxxxxx Xxxxxxxxxxxxx xxxxxxxxxxxxx podle xxxxxx x xxxxxxxxxxxxxx xxxxxxxxxxxx12) xxx/xxx ne/no Xxxxxxx approval xx Xxxxxxxx xx xxxxxx xxxxxxxxx xx Xxxxxxx Xxxxxxx Xxx |
2670 | Xxxxxxxxx x zdravotnickém xxxxxxxxxx xxxxxxxxx Product xxxxxxxxxxx enclosed xxx/xxx xx/xx |
2680 | Xxxxxxxxxxxx prostředek xxxxxx xx xxx / Medical xxxxxx xxxxxx xx xxx xxxxxx10) xxxxx xxxxxx x technických požadavcích xx xxxxx xxxxxx o xxxxxxxxxxxxxx prostředcích12) xxxxxxx13) xxxxxxxxx xx xxx Xxx xx Xxxxxxxxx Xxxxxxx xxxxxxxxx xx Xxxxxxx Xxxxxxx Xxx xx Xxxxxxxx |
2690 | Xxxxx úřady xxxx xxxxxxxxxxx? Which xxxxx Xxxxxxxxxxx were notified? |
Xxxxxxxx/Xxxx:
Xxxxxxxxxx tohoto xxxxxxx nepředstavuje xxxxxxxxxx xxx xxxxx xxxxxxx xxxx jeho xxxxxxxxxxxxxx xxxxxxxx xxx xxxxxxxxxxx xxxxx x úplnosti x přesnosti, ani x xxx, xx xxxxxxxxxxxx xxxxxxxxxx xxxxxxx xxxxxx xxxx xxxxxxxx xxxx xxxxxxx x xxxxxxxx stavu xxxxxxxx xxxxx.
Xxxxxxxxxx xx xxxx xxxxxx xxxx xxx, in itself, xxxxxxxxx a conclusion xx xxx manufacturer xxx/xx xxxxxxxxxx representative xx the xxxxxxxxx xxxxxxxxx xxxx the xxxxxxx xx this xxxxxx xx xxxxxxxx xx xxxxxxxx, that xxx xxxxxx(x) xxxxxx xxxxxx xx xxx xxxxxx xxx/xx that xxx medical xxxxxx(x) xxxxxx xx contributed xx the alleged xxxxx xx deterioration xx xxx xxxxxx xx xxx xxxxxx.
Xxxxxx prohlašuji, že xxxxxxx informace jsou xxxxxxx x xxxxxxxx.
X affirm that xxx xxxxxxxxxxx xxxxx xxxxx xx xxxxxxx xx xxx xxxx xx my xxxxxxxxx.
Xxxx ........................................... Datum ...................................
Xxxx Xxxx
Jméno, xxxxxxxx ........................... Xxxxxx ........................
Name, xxxxxxx Xxxxxxxxx
Xxxxxxxx x xxxx xxxxxxx:/Xxxxx xxx other xxxxxxxxxxx:9)
2700 | Xxxxxxxx xxxxxxxx / Xxxxxxxxxx xxxxx vyplní xxxxxxxxx xxxx – XXXX / Xx xx xxxxxx xx only xx the xxxxxxxxx xxxxxxxxx Xxxxx xxxxxxxx xxxxxxxxxxx xxxxx / Xxxx of xxxxxxxx xx competent xxxxxxxxx6) | ||
2710 | Xxxxxxxxxx xxxxxxxxx / Preson xxxxxxxxxxx | 2920 | Xxxxxxx/Xxxxxxxxx xxxxxx |
2730 | Xxxxx předání Xxxxxx xxxxxxxxxxxxxx informací x xxxxxxxxxxx/ Xxxx xx xxxxxxxx xx xxxxxxxxx xx Xxxxxx Information xxx Statistics6) | ||
Pokyny k xxxxxxxxxx xxxxxxxxx
Xxxxx xx xxxxxxxxxx xxxx:
1) Xxxxxx xx x xxxxxxxxxxxx xxxx xxxxx (xxxxx ISO 3166), lomítka x (XXX) xxxxxxxxxxxxxxx xxxxx xxxxxxxx.
1) Xxxx xxxx is xxxxxx xxxxxxxx of xxx xxx-xxxxxxx country xxxx xx standard ISO 3166 followed xx x xxxxx and xxx identity-number xx xxx xxxxxxx.
2) Xxxxxx xxxxxxx xxxx xxxxxxxxxxxx xxxxxxxx. Vyplňuje xx ode dne xxxxxxxxx xxxxxxx x xxxxxxxxxxx Xxxxx xxxxxxxxx xx Xxxxxxxx xxxx, xxxxx xxxxxxxxxxxx prostředek xxxxxxx xxxxxxxxx xxxxxxxx xx xxxxx x xxxxxxxx x xxxxxxxxx xxxxx Xxxxxxxxxx xxxxxxxxxxxx.
2) To be xxxxxx in by x manufacturer xx xx xx authorized xxxxxxxxxxxxxx. Xx xx xxxxxx xx xxxx xxx day xxxx x contract xxxxxxxxxx xxx entrance xx xxx Czech Republic xxxx the European Xxxxx xx xxxxx, xxxxxxxxx xxxx x xxxxxxx xxxxxx taking xxxx in xx xxxxxxxx xxxxxxxxxx in xxxx xx the xxxxxx states of xxx European Union.
3) Xxxxxxxx xxxx xxx země x xxxxxxx x normou XXX 3166: 1993, xxxxxxxxx:
3) Xxxxxx xxx the xxxxx xxx xxx xxxxxxxxx xxxxxxxxx (xxx. xx xxxxxxxx XXX 3166: 1993), x.x.:
AT ... Xxxxxxxx / Xxxxxxx XX ... Xxxxx / Xxxxxxx
BE ... Xxxxxx / Xxxxxxx XX ... Xxxxxx / Xxxxxxx
DE ... Xxxxxxx / Germany XX ... Xxxxxx / Xxxxx
XX ... Xxxxxx / Denmark XX ... Xxxxxxxxxxxxxxx / Xxxxxxxxxxxxx
ES ... Xxxxxxxxx / Spain XX ... Xxxxxxxxxxx / Xxxxxxxxxx
XX ... Xxxxxx / Xxxxxxx NL ... Nizozemsko / Netherlands
XX ... Xxxxxxx / Xxxxxx XX ... Norsko / Xxxxxx
XX ... Velká Xxxxxxxx / Xxxxxx Xxxxxxx PT ... Portugalsko / Portugal
GR ... Xxxxx / Xxxxxx XX ... Xxxxxxx / Xxxxxx
4) Použijte xxxx xxxxx xxxxx Xxxxxxxx XXX xx xxx 27.4.1999, částka 33/1999 Xx., v xxxxxxx znění.
4) Xxxxxx use xxx xxxxxx xxxxx prescribed xx XXX Disposition xxxx 27.4.1999, xxxx 33/1999 Coll. xx xxxxxxx.
5) Vyplňte xxxxx a xxxxxxxx x xxxxxxx xxxxx, xxxxx xxxx xxxxxxxx xxxxx, jde-li x xxxxxxxxxx xxxxx.
5) Xxxxxx xxxxx x xxxxx xxxx xxx x xxxxxxx xx xxxx xx x xxxxxxxx xxxxxx, and xx case xx x xxxxx xxxxxx xxx xxxx xx x name xx x xxxxxxxxxx company.
6) Xxx, měsíc, xxx
6) Xxxx, xxxxx, xxx
7) Xxxxxxx xxxxxxx xxxx x xxxxx skupiny xxxxxxxxxxxxxx xxxxxxxxxx xxxxx Xxxxxxxxxxxxx xxxxxxxxxxxxxxx systému (XXXXX) xxxx xxxxx Xxxxxxxx xxxxxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx (GMDN), až xxxx x xxxxxxxxx (xxxx. 10966; xxxxxx, xxx).
7) Xxxxxx xxxxx the xxxxxxxx xxxx and xxx xxxxxxxxxxx xxxx the xxxxxxxxxxxx Xxxxxxxxx Xxxxxxx Xxxxxx Nomenclature Xxxxxx (XXXXX) or Global Xxxxxxx Xxxxxxx Nomenclature (XXXX), xxxx xxxxx xx xxxxxxxxx (e.g. 10966; Compresses, Xxxxx).
8) Xxxx x xxxxx xxxxxxxxx jsou xxxxxxxx xx XXX XX ISO 15225: 2000. Výrobek se xxxxxxxx xxxxx první xxxxxx kategorie, do xxxxx xxxxx x xxxxxx xx xxxxxxx x xx xxxxxxx X.
8) Xxxxxx xxxxxxxx xxxx xxx xxxx xxx xxxxx xx XXX XX XXX 15225: 2000. Xxx xxxxxx xxxxx xx xxxxxxxx xx xxx xxxxx xxxxxxxx xx which it xxxx, moving xxxx x to X.
Xxx kat. | Xxxxx xxxxxxxxx zdrav. xxxxxxxxxx | X | Xxxx xx xxx. | Name xx xxxxxxxx xx medical xxxxxxx | R |
06 | Xxxxxxxxxxxx zdravotnické prostředky xx xxxxx Xx xxxxx diagnostic xxxxxxx | x | 02 | Anestetické x xxxxxxxxxx zdravotnické xxxxxxxxxx Anaesthetic / xxxxxxxxxxx devices | g |
01 | Aktivní implantabilní xxxxxxxxxxxx xxxxxxxxxx Xxxxxx xxxxxxxxxxx xxxxxxx | x | 04 | Xxxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxxx xxxxxxx | x |
07 | Xxxxxxxxx xxxxxxxxxxxxx xxxxxxxxxxxxx prostředky Xxx-xxxxxx xxxxxxxxxxx xxxxxxx | x | 09 | Xxxxxxxxxxxx prostředky – xxxxxxxx pro xxxxxxxxx xxxxxxx Reusable xxxxxxxxxxx | i |
03 | Xxxxxxxxxxxxxx zdravotnické prostředky Xxxxxx devices | x | 10 | Xxxxxxxxxxxx xxxxxxxxxx xxx jednorázové xxxxxxx Xxxxxx xxx devices | x |
08 | Xxxxxxxxxxxxxx x xxxxxxx xxxxxxxxxxxx xxxxxxxxxx Ophthamic and xxxxxxx xxxxxxx | x | 11 | Zdravotnické prostředky xxx xxxxxxxxx osoby Xxxxxxxxx aids xxx xxxxxxxx xxxxxxx | k |
12 | Xxxxxxxxxxxx prostředky xxx xxxxxxxxxxx x xxxxxxx zářením Xxxxxxxxxx xxx therapeutic xxxxxxxxx | x | 05 | Zdravotnické xxxxxxxxxx x xxxxxxxxxxx xxxxxxxx Xxxxxxxx xxxxxxxx | x |
9) X případě xxxxxxx xxxxxxxx xxxxx xxxx papíru.
9) Xxx xxxxxxxxxx xxxxx xx xxxxxxxxx.
10) Xxxxxxx pouze x xxxxxxx, že xxxxxx xxxxxx SÚKLu xxxxxxx xxxx zplnomocněný zástupce.
10) To xx xxxxxx xx only xx xxxxxxxxxxxx / xxxxxxxxxx xxxxxxxxxxxxxx is xxxxxxxxx xx XXXX.
11) X Xxxxx xxxxxxxxx xxxxx č. 18/1997 Xx., o xxxxxxx xxxxxxxxx jaderné xxxxxxx a ionizujícího xxxxxx (xxxxxxx xxxxx) x o změně x xxxxxxxx xxxxxxxxx xxxxxx, xx znění xxxxxxxxxx předpisů.
11) Xx Xxxxx Xxxxxxxx Xxx Xx. 18/1997 Xxxx., on Xxxxxxxxx Xxxxxxxxxxx of Xxxxxxx Xxxxxx xxx xxxxxxxx Xxxxxxxxx (Xxxxxx Act) xxx amendments xxx xxxxxxx xxxx Xxxx xx xxxxxxx.
12) X České xxxxxxxxx xxxxx č. 123/2000 Xx., x zdravotnických xxxxxxxxxxxx a x xxxxx některých xxxxxxxxxxxxx xxxxxx, ve xxxxx xxxxxx č. 130/2003 Xx.
12) Xx Xxxxx Xxxxxxxx Act Xx. 123/2000 Coll., xx Xxxxxxx Devices xxx amendments to xxxx xxxxxxx Xxxx xx xxxxxxx Act Xx. 130/2003 Xxxx.
13) X Xxxxx xxxxxxxxx xxxxx x. 22/1997 Xx., o xxxxxxxxxxx xxxxxxxxxxx xx xxxxxxx x o xxxxx a xxxxxxxx xxxxxxxxx xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx.
13) Xx Czech Xxxxxxxx Act Xx. 22/1997 Xxxx., xx Xxxxxxxxx Xxxxxxx xx Xxxxxxxx and amendments xxx xxxxxxxx xxxx Xxxx as xxxxxxx.
Příloha x. 2 x vyhlášce x. 501/2000 Sb.
Xxxxxxxx II
xxx xxxxxxxxx xxxxxxx nežádoucí xxxxxxx xxxxxxxxxxxxxx prostředku
Xxxxxxxx Xxxxx Xxxxxx Xxxx
3100 | Xxxxxxxxx xxxx xxxxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxx / Xxxxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxx Xxx xxxxxxxxxxx xxxxx / Xxxx xx xxxxxxxxx authority XX/XX02 | ||
3110 | Xxxxx xxxxxxxxxxx úřadu / Xxxx xx xxxxxxxxx xxxxxxxxx Xxxxxx xxxxx xxx xxxxxxxx xxxxx (xxxx xxx „XXXX“) | ||
3120 | Xxxxx, číslo xxxx a/nebo xxxxxxxx xxxxxxxx / Xxxxxx, xxxxx xxxxxx and/or XX xxx Xxxxxxxxx 48 | ||
3130 | XXX / Xxxxxx xxxx 100 41 | 3140 | Xxxx / Xxxx Xxxxx 10 |
3150 | Xxxxxxx / Xxxxxxxxx xxxxxx 272 185 780, 272&xxxx;185&xxxx;705 | 3160 | Xxx / Xxx number 272 185 764 |
3170 | X-Xxxx xxxx@xxxx.xx | 3180 | Xxxx / Xxxxxxx XX |
3190 | Xxxxxxx xxx XXXX od xxxxxxxx, xxxxx xxxxx xxxxxxxxx xxxxxxx / Xxxxxx xx XXXX xx subject xxxxxxxxxx xxxxxxx xxxxxxxx Název xxxxxxxx, který xxxxxx xxxxxx / Name xx xxxxxxx submitting xxxxxx | ||
3195 | Xxx xxxxxxx / Xxxx of subject1) | ||
3200 | Xxxxxxx / Xxxxxxxxxxxx Xxxxxxxx / Xxxx Xxxxxxxxxxxx xxxxxxxx / Xxxxxxxxxx representative2) Ostatní / Xxxxx Xxxxxxx / Xxxxxxxx | ||
3210 | Xxxxx, číslo xxxx x/xxxx poštovní xxxxxxxx / Xxxxxx, xxxxx xxxxxx and/or XX xxx | ||
3220 | XXX / Xxxxxx xxxx | 3230 | Xxxx / City |
3240 | Xxx xxxxx / Xxxxxxx code 2) | 3250 | Xxx xxxxx / Xxxxxx xxxx3) |
3260 | Xxxxx xxxxxxxxx xxxxx / Xxxx xx xxxxxxx xxxxxx4) | ||
3270 | Xxxxxxx / Xxxxxxxxx xxxxxx | 3280 | Xxx / Xxx number |
3290 | X-Xxxx | ||
3300 | Xxxxx xxxxxxx / Xxxx xx xxxxxx5) | ||
3310 | Xxxxx xxxxxxxxx xxxxxxx (xxxxxxxxx SÚKL) Incident xxxxxx (xxxxxxxxxx xxxxxx xxxxxxxx xx XXXX) XX/XX02/..... |
3320 | Xxxxxxxxxxxx prostředek / Xxxxxxx xxxxxx Xxxxx zdravotnického xxxxxxxxxx / Xxxxxxxxxx xxxx of xxxxxxx xxxxxx |
3330 | Xxx xxxxxxx zdravotnického xxxxxxxxxx xxxxx XXXXX / XXXX7) UMDS / GMDN xxxx xx xxxxxxx device |
3340 | Xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxx xxxxx UMDNS / GMDN (např. xxxxxxxxxxxxxxxxx, xxxxxx xxxxxxxxxx)7) XXXXX / GMDN xxxxxxxxxxx xx medical xxxxxx xx Czech (x.x. Xxxxxxxxxx, Cardiac, Xxxxxxxx Noninvasive) |
3345 | Xxx kategorie xxxxxxxxxxxxxx xxxxxxxxxx8) Xxxxxxxx xx xxxxxxx device |
3350 | Modelové xxxx xxxxxxxxxxx číslo xxxxxxxxxxxxxx xxxxxxxxxx / Xxxxx xx xxxxxxxxx xxxxxx |
3360 | Xxxxx(x) série xxxx xxxxx xxxxxxxxxxxxxx xxxxxxxxxx Xxxxxx number(s) or xxx number(s) |
3370 | Xxxxxxxxxxxxx zdravotníckého xxxxxxxxxx xxxxxxxx xx xxxxxxxx8) Xxxxxxxxxx xxxxxxx xxxxxxx/xxxxxxxxxxx (xx xxxxxxxxxx) |
3380 | Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxx xx xxxxxxxx8) Xxxxxxxx xxxxxxx (if xxxxxxxxxx) |
3390 | Xxxxxxx / Xxxxxxxxxxxx Xxx xxxxxxx / Xxxx xx xxxxxxxxxxxx1) |
3400 | Jméno xxxxxxx / Xxxx xx xxxxxxxxxxxx4) |
3410 | Xxxxxxxxxxxxx xxxxx xxxxxxxxxxxx xxxxx, xxxxx xxxxx xxxxxxxxx. Xxxxxxxxxxxxxx xxxxxx xx Xxxxxxxx Xxxx xxxxxxxx xx conformity xxxxxxxxxx. |
2410 | Xxxxxx xxxxx xxxxxxx již xxxxx xxxxxxxxx xxxxxxx zdravotnického xxxxxxxxxx xxxxxxxx xxxx? Xxx the xxxxxxxxx xxxx xxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx xxxx xxxxxxx xxxxxx? ano / xxx xx /xx |
2420 | Xxxxx xxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx / Xxxx xx xxxxxx of xxxxxxx incident5) |
2430 | Xxxxxxxx xxx, xxx xx xxxxx xxxx (ze zemí XX, kde se xxxxxxxxxxxx xxxxxxxxxx xxxxxxx)9) Xx xxx, to xxxxx country (other XXX countries where xxx xxxxxxx xxxxxx xx xx sale) XX XX XX XX XX FI XX XX XX XX XX XX XX XX NL XX XX XX |
3450 | Xxxxxxx xxxxxxxxx xxxxxxx / xxxxxx Xxxxxxxxxxxxx / conclusions Xxxxxxxx x xxxxx xxxxxxx xxxxxxxxxxx výrobcem8) Xxxxxx xxx xxxxxxxxxx of xxxxxxxxxxxx´x investigation |
3460 | Další šetření xxxxxxxxx xxxxxxx (xxxxxxxx xxxx xxxxxxxxx)8) Further xxxxxxxxxxxxx (xx any) |
3470 | Xxxxxxxxx xxxxxxxx xxxxxxxx (xxxxxxxx xxxx xxxxxxx)8) Xxxxxxx xxxxxxxxxx action (xx xxx) |
3480 | Xxxxxx rozvrh xxxxxxxxxx xxxxxxxx / Xxxxxxx xxxxxxxx xx xxxxxxxxxx xxxxxx (xx xxx) |
Xxxxxxxx/Xxxx:
Xxxxxxxxxx xxxxxx xxxxxxx xxxxxxxxxxxxx xxxxxxxxxx ani xxxxx výrobce xxxx xxxx zplnomocněného xxxxxxxx xxx xxxxxxxxxxx úřadu x úplnosti x xxxxxxxxx, xxx x xxx, xx xxxxxxxxxxxx xxxxxxxxxx xxxxxxx xxxxxx xxxx xxxxxxxx xxxx xxxxxxx x zhoršení xxxxx xxxxxxxx xxxxx.
Xxxxxxxxxx of xxxx xxxxxx xxxx xxx, xx itself, xxxxxxxxx x xxxxxxxxxx xx xxx xxxxxxxxxxxx and/or xxxxxxxxxx xxxxxxxxxxxxxx or xxx competent xxxxxxxxx xxxx the xxxxxxx xx this xxxxxx xx complete or xxxxxxxx, xxxx xxx xxxxxx(x) listed xxxxxx xx xxx xxxxxx xxx/xx that xxx xxxxxxx xxxxxx(x) xxxxxx xx xxxxxxxxxxx to xxx xxxxxxx death xx deterioration xx xxx xxxxxx xx xxx xxxxxx.
Xxxxxx xxxxxxxxxx, že xxxxxxx xxxxxxxxx xxxx xxxxxxx x xxxxxxxx.
I xxxxxx xxxx the xxxxxxxxxxx given xxxxx xx correst to xxx xxxx xx xx xxxxxxxxx.
Xxxx ........................................... Xxxxx ...................................
City Xxxx
Xxxxx, xxxxxxxx ........................... Xxxxxx ........................
Xxxx, xxxxxxx Signature
Xxxxxxxx a jiná xxxxxxx: / Xxxxx xxx xxxxx xxxxxxxxxxx:8)
3490 | Procesní xxxxxxxx / Xxxxxxxxxx xxxxx Xxxxxx příslušný xxxx / To be xxxxxx in xxxx xx xxx competent xxxxxxxxx Xxxxx xxxxxxxx xxxxxxxxxxx xxxxx / Xxxx xx xxxxxxxx xx competent authority5) | ||
3500 | Zodpovědný xxxxxxxxx / Xxxxxx xxxxxxxxxxx | 3510 | Xxxxxxx/Xxxxxxxxx number |
3520 | Xxxxx předání Xxxxxx xxxxxxxxxxxxxx xxxxxxxxx x xxxxxxxxxxx5) | ||
Pokyny k xxxxxxxxxx formuláře
Xxxxx xx xxxxxxxxxx xxxx:
1) Skládá xx x xxxxxxxxxxxx xxxx xxxxx (xxxxx ISO 3166), xxxxxxx a (XXX) xxxxxxxxxxxxxxx čísla xxxxxxxx.
1) Xxxx xxxx is xxxxxx xxxxxxxx xx xxx xxx-xxxxxxx xxxxxxx xxxx xx xxxxxxxx XXX 3166 xxxxxxxx xx x xxxxx xxx xxx xxxxxxxx-xxxxxx xx xxx subject.
2) Xxxxxxxx kódy pro xxxx x xxxxxxx x xxxxxx ISO 3166: 1993, xxxxxxxxx:
2) Xxxxxx xxx xxx codes xxx xxx xxxxxxxxx xxxxxxxxx (xxx. to standard XXX 3166: 1993), x.x.:
XX ... Rakouska / Xxxxxxx XX ... Xxxxx / Xxxxxxx
XX ... Xxxxxx / Xxxxxxx XX ... Xxxxxx / Xxxxxxx
XX ... Xxxxxxx / Xxxxxxx XX ... Xxxxxx / Xxxxx
XX ... Xxxxxx / Xxxxxxx XX ... Lichtenštejnsko / Liechtenstein
XX ... Xxxxxxxxx / Xxxxx XX ... Xxxxxxxxxxx / Xxxxxxxxxx
XX ... Finsko / Xxxxxxx NL ... Xxxxxxxxxx / Xxxxxxxxxxx
XX ... Xxxxxxx / Xxxxxx NO ... Xxxxxx / Xxxxxx
GB ... Xxxxx Xxxxxxxx / Xxxxxx Kingdom PT ... Xxxxxxxxxxx / Xxxxxxxx
XX ... Xxxxx / Xxxxxx XX ... Švédsko / Xxxxxx
3) Xxxxxxxx xxxx xxxxx xxxxx Xxxxxxxx XXX xx dne 27.4.1999, xxxxxx 33/1999 Xx., x xxxxxxx znění.
3) Please xxx xxx xxxxxx xxxxx xxxxxxxxxx xx XXX Xxxxxxxxxxx from 27.4.1999, xxxx 33/1999 Coll. xx xxxxxxx.
4) Xxxxxxx xxxxx x xxxxxxxx x xxxxxxx xxxxx, xxxxx xxxx xxxxxxxx xxxxx, jde-li x xxxxxxxxxx xxxxx.
4) Xxxxxx xxxxx x first xxxx xxx a xxxxxxx xx case xx x xxxxxxxx xxxxxx, xxx in case xx a legal xxxxxx xxx name xx a xxxx xx x xxxxxxxxxx xxxxxxx.
5) Xxx, xxxxx, xxx
5) Xxxx, xxxxx, xxx
6) Xxxxxxx správné xxxx a xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxx Xxxxxxxxxxxxx nomenklaturního xxxxxxx (UMDNS) nebo xxxxx Xxxxxxxx xxxxxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx (XXXX), xx xxxx x xxxxxxxxx (xxxx. 10966; xxxxxx, xxx).
6) Xxxxxx xxxxx xxx xxxxxxxx code xxx xxx xxxxxxxxxxx from xxx nomenclature Xxxxxxxxx Xxxxxxx Device Xxxxxxxxxxxx Xxxxxx (UMDNS) xx Xxxxxx Medical Devices Xxxxxxxxxxxx (XXXX), xxxx xxxxx xx available (x.x. 10966; Xxxxxxxxxx, Xxxxx).
7) Kódy x xxxxx kategorie xxxx xxxxxxxx xx XXX EN XXX 15225: 2000. Výrobek xx xxxxxxxx kódem xxxxx xxxxxx xxxxxxxxx, xx xxxxx xxxxx x xxxxxx xx xxxxxxx x xx xxxxxxx X.
7) Xxxxxx xxxxxxxx xxxx xxx term are xxxxx xx CSN XX ISO 15225: 2000. Xxx xxxxxx xxxxx xx xxxxxxxx xx xxx first xxxxxxxx xx xxxxx xx xxxx, moving xxxx x to X.
Kód xxx. | Xxxxx kategorie zdrav. xxxxxxxxxx | X | Xxxx xx cat. | Name xx xxxxxxxx xx xxxxxxx xxxxxxx | X |
06 | Xxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx in xxxxx Xx xxxxx xxxxxxxxxx xxxxxxx | x | 02 | Xxxxxxxxxxx x xxxxxxxxxx xxxxxxxxxxxx prostředky Anaesthetic / respiratory xxxxxxx | x |
01 | Xxxxxxx xxxxxxxxxxxxx zdravotnické xxxxxxxxxx Xxxxxx xxxxxxxxxxx devices | x | 04 | Elektromechanické xxxxxxxxxxxx xxxxxxxxxx Electro xxxxxxxxxx xxxxxxx devices | x |
07 | Xxxxxxxxx xxxxxxxxxxxxx zdravnotnické xxxxxxxxxx Xxx-xxxxxx xxxxxxxxxxx xxxxxxx | x | 09 | Xxxxxxxxxxxx xxxxxxxxxx – xxxxxxxx xxx xxxxxxxxx xxxxxxx Xxxxxxxx xxxxxxxxxxx | i |
03 | Stomatologické xxxxxxxxxxxx xxxxxxxxxx Xxxxxx xxxxxxx | x | 10 | Xxxxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxxxx xxxxxxx Xxxxxx use xxxxxxx | x |
08 | Xxxxxxxxxxxxxx x xxxxxxx xxxxxxxxxxxx prostředky Xxxxxxxxx xxx xxxxxxx devices | x | 11 | Xxxxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxx xxxxx Xxxxxxxxx xxxx xxx xxxxxxxx persons | x |
12 | Xxxxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxxxx x xxxxxxx xxxxxxx Xxxxxxxxxx xxx therapeutic xxxxxxxxx | f | 05 | Xxxxxxxxxxxx xxxxxxxxxx x xxxxxxxxxxx xxxxxxxx Xxxxxxxx xxxxxxxx | x |
8) X xxxxxxx xxxxxxx použijte xxxxx list xxxxxx.
8) Xxx xxxxxxxxxx xxxxx if xxxxxxxxx.
9) Xxxxxx xxxxxxx xxxx zplnomocněný xxxxxxxx. Xxxxxxxx xx ode xxx xxxxxxxxx xxxxxxx x xxxxxxxxxxx České xxxxxxxxx xx Evropské xxxx, xxxxx xxxxxxxxxxxx xxxxxxxxxx xxxxxxx nežádoucí xxxxxxxx xx xxxxx x xxxxxxxx z xxxxxxxxx xxxxx Xxxxxxxxxx xxxxxxxxxxxx.
9) To xx filled xx xx x manufacturer xx xx xx xxxxxxxxxx representative. To xx xxxxxx xx xxxx the xxx xxx when x xxxxxxxx concerning xxx xxxxxxxx xx xxx Xxxxx Republic xxxx xxx Xxxxxxxx Xxxxx xx xxxxx, xxxxxxxx xxxx x xxxxxxx xxxxxx taking xxxx xx xx xxxxxxxx xxxxxxxxxx in xxxx xx xxx xxxxxx xxxxxx of xxx Xxxxxxxx Xxxxx.".
Čl. XX
Xxxx xxxxxxxx nabývá xxxxxxxxx xxxx 1. xxxxx 2003.
Xxxxxxxxxx:
MUDr. Součková x. x.
Xxxxxxxxx
Xxxxxx předpis x. 304/2003 Sb. xxxxx xxxxxxxxx xxxx 1.10.2003.
Xxxxxx xxxxxxx č. 304/2003 Xx. byl xxxxxx xxxxxxx xxxxxxxxx č. 268/2014 Sb. x xxxxxxxxx od 1.4.2015.
Xxxxx jednotlivých xxxxxxxx xxxxx xxxxxx právních xxxxxxxx x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx xxxx xxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx.