This document is an excerpt from the EUR-Lex website
National transposition measures communicated by the Member States concerning:
Richtlinie 98/79/EG des Europäischen Parlaments und des Rates vom 27. Oktober 1998 über In-vitro-Diagnostika
OJ L 331, 7.12.1998, p. 1–37 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)
Special edition in Czech: Chapter 13 Volume 021 P. 319 - 355
Special edition in Estonian: Chapter 13 Volume 021 P. 319 - 355
Special edition in Latvian: Chapter 13 Volume 021 P. 319 - 355
Special edition in Lithuanian: Chapter 13 Volume 021 P. 319 - 355
Special edition in Hungarian Chapter 13 Volume 021 P. 319 - 355
Special edition in Maltese: Chapter 13 Volume 021 P. 319 - 355
Special edition in Polish: Chapter 13 Volume 021 P. 319 - 355
Special edition in Slovak: Chapter 13 Volume 021 P. 319 - 355
Special edition in Slovene: Chapter 13 Volume 021 P. 319 - 355
Special edition in Bulgarian: Chapter 13 Volume 025 P. 5 - 41
Special edition in Romanian: Chapter 13 Volume 025 P. 5 - 41
Special edition in Croatian: Chapter 13 Volume 054 P. 33 - 69
The member states bear sole responsibility for all information on this site provided by them on the transposition of EU law into national law. This does not, however, prejudice the results of the verification by the Commission of the completeness and correctness of the transposition of EU law into national law as formally notified to it by the member states. The collection National transposition measures is updated weekly.
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Arrêté royal du 18/03/1999 relatif aux dispositifs médicaux MB du 14/04/1999, page 12105
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Zákon č. 22/1997 Sb., o technických požadavcích na výrobky a o změně a doplnění některých zákonů
Zákon č. 123/2000 Sb., o zdravotnických prostředcích a o změně některých souvisejících zákonů
Zákon č. 64/2014 Sb., kterým se mění některé zákony v souvislosti s přijetím kontrolního řádu
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Bekendtgorelse om medicinsk udstyr ref: Bekendtgorelse n° 92
Bekendtgorelse om medicinsk udstyr til in vitro-diagnostik ref: Bekendtgorelse n° 89 af 04/02/2000
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Zweites Gesetz zur Änderung des Medizinproduktegesetzes (2.MPG-AndG) vom 13.Dezember 2001.
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Ohujuhtumist teavitamise kord ja teavitamisvormid
Meditsiiniseadmete liigitamise reeglid
Meditsiiniseadme vastavushindamise kord1
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Medical Devices (Amendment) Regulations 2001 S.I. n° 444 of 2001
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Décision ministérielle commune 3607/892 FEK n° 1060B du 10/08/2001, page 14739
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Zakon o medicinskim proizvodima
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Medicīnisko ierīču un medicīnisko preču reģistrācijas,realizācijas un izpildīšanas kārtība
Medicīnisko ierīču un medicīnisko preču eksplutācijas un tehniskās uzraudzības kārtība
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Règlement grand-ducal du 24/07/2001 Mémorial A n° 93 du 10/08/2001
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8/2003. (III. 13.) ESzCsM rendelet az in vitro diagnosztikai orvostechnikai eszközökről
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VO über die Klassifizierung von Medizinprodukten BGBl. Teil II nr. 381/2000
VO über die grundlegenden Anforderungen an Medizinprodukte BGBl. Teil II nr. 9/2001
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Ustawa z dnia 20 kwietnia 2004 roku o wyrobach medycznych
Ustawa z dnia 20 maja 2010 r. o wyrobach medycznych
Rozporządzenie Ministra Zdrowia z dnia 23 września 2010 r. w sprawie wzoru znaku CE
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Decreto - Lei n° 189/2000 Diário da republica - I Serie A n° 186 de 12/08/2000
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Zakon o zdravilih in medicinskih pripomočkih
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Zákon č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach a o zmene a doplnení niektorých zákonov
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Sosiaali- ja terveysministeriön päätöksen muuttamisesta; 28/09/2000 832/2000 page 2183
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The In Vitro Diagnostic Medical Devices Regulations 2000 S.I. n° 1315 of 2000