Internal Law 8 Health - Employment - Social security 81 Health
Diritto nazionale 8 Sanità - Lavoro - Sicurezza sociale 81 Sanità

812.219 Ordinance of 26 May 2022 on In Vitro Diagnostic Medical Devices (IvDO)

812.219 Ordinanza del 4 maggio 2022 sui dispositivi medico-diagnostici in vitro (ODIv)

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Art. 81 Validity of certificates issued under the old legislation

Certificates issued under the old legislation retain their validity until the expiry date stated therein, but no longer than 26 May 2025.

Art. 82 Placing on the market of devices that comply with the old legislation

1 Provided the following devices continue to comply with the old legislation as of 26 May 2022 and have not undergone any significant changes in their design or intended purpose, they may be placed on the market or put into service until the following dates:

a.
devices with a certificate valid under Article 81: until 26 May 2025;
b.
devices that did not require the involvement of a designated body in connection with the conformity assessment procedure according to the old legislation, but which is now required by this Ordinance, and for which a declaration of conformity was issued before 26 May 2022 under the old legislation:
1.
Class D devices: until 26 May 2025,
2.
Class C devices: until 26 May 2026,
3.
Class B devices: until 26 May 2027,
4.
Class A devices placed on the market in a sterile condition: until 26 May 2027.

2 The post-market surveillance of devices specified in paragraph 1, their market surveillance, vigilance, registration of economic operators and of the devices themselves are subject to the provisions of this Ordinance.

3 Devices legally placed on the market prior to 26 May 2022 under the old legislation may continue to be made available on the market or put into service until 26 May 2025.

4 Devices legally placed on the market prior to 26 May 2022 in accordance with paragraph 1 may continue to be made available on the market or put into service until the following dates:

a.
devices specified in paragraph 1 letters a and b point 1: until 26 May 2026;
b.
devices specified in paragraph 1 letter b point 2: until 26 May 2027;
c.
devices specified in paragraph 1 letter b points 3 and 4: until 26 May 2028.

Art. 83 Requirements for devices manufactured and used in healthcare institutions

The requirements set out in Article 9 for devices manufactured and used in healthcare institutions shall apply from the following dates:

a. the requirements set out in Article 5 paragraph 5 letters b, c and e-i EU-IVDR63: from 26 May 2024;

b. the requirements set out in Article 5 paragraph 5 letter d EU-IVDR: 26 May 2028.

63 See the footnote to Art. 4 para. 1 let. e

Art. 81 Validità dei certificati rilasciati secondo il diritto anteriore

I certificati rilasciati secondo il diritto anteriore restano validi fino alla fine del periodo indicato sugli stessi, ma al più tardi fino al 26 maggio 2025.

 

This document is not an official publication. Only the publication of the Federal Chancellery is legally binding.
Il presente documento non è una pubblicazione ufficiale. Fa unicamente fede la pubblicazione della Cancelleria federale. Ordinanza sulle pubblicazioni ufficiali, OPubl.