1.

Notifying Member: European Union

If applicable, name of local government involved (Article 3.2 and 7.2):

2.

Agency responsible: European Commission

Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:

European Commission
EU-TBT Enquiry Point
Fax: +(32) 2 299 80 43
E-mail: grow-eu-tbt@ec.europa.eu
Website: http://ec.europa.eu/growth/tools-databases/tbt/

3.

Notified under Article 2.9.2 [ ], 2.10.1 [ ], 5.6.2 [X], 5.7.1 [ ], other:

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): In vitro diagnostic medical devices.

5.

Title, number of pages and language(s) of the notified document: Draft Commission Decision amending Decision 2002/364/EC as regards requirements for HCV antigen/antibody combined tests and Nucleic Acid Amplification techniques in qualitative HIV assays (3 pages + Annex 2 pages, in English)

6.

Description of content: This draft decision updates the common technical specifications, set out in article 5.3 of the Directive 98/79/EC on in vitro diagnostic medical devices, for some in vitro diagnostic medical devices according to the state of the art, notably regarding HCV antibody/antigen combined tests and Nucleic Acid Amplification techniques ("NAT") assays for HIV.

7.

Objective and rationale, including the nature of urgent problems where applicable: The objective of this decision is to improve the level of safety of some in vitro diagnostic medical devices put on the EU market: specifically hepatitis C virus (HCV) antibody/antigen combined tests and nucleic acid amplification technique (NAT) for HIV assays.

It will reinforce the control by notified bodies of the placing on the market of these in vitro diagnostic medical devices, ensure an equal level playing field for all industry actors and a better functioning of the internal market.

8.

Relevant documents: Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (Official Journal L 131, 16/05/2002 P. 0017 - 0030):

http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1484579511153&uri=CELEX:02002D0364-20120701

9.

Proposed date of adoption: 4th quarter 2017

Proposed date of entry into force: 20 days from publication in the Official Journal of the EU. There is a transition period of 6 months following entry into force of the regulation.

10.

Final date for comments: 60 days from notification

11.

Texts available from: National enquiry point [ ] or address, telephone and fax numbers and email and website addresses, if available, of other body:

European Commission
EU-TBT Enquiry Point
Fax: + (32) 2 299 80 43
E-mail: grow-eu-tbt@ec.europa.eu

The text is available on the Website: http://ec.europa.eu/growth/tools-databases/tbt/

https://members.wto.org/crnattachments/2017/TBT/EEC/17_1593_00_e.pdf

https://members.wto.org/crnattachments/2017/TBT/EEC/17_1593_01_e.pdf