Decision No 2/2003

of 17 September 2003

of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment on the listing of a conformity assessment body under the sectoral chapter for medical devices

(2003/854/EC)

THE COMMITTEE,

Having regard to the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (the Agreement) signed on 21 June 1999, and in particular Article 10(4)(a) and Article 11 thereof,

Whereas the Agreement entered into force on 1 June 2002,

Whereas the Committee is to take a decision to list a conformity assessment body or bodies under a sectoral chapter of Annex I to the Agreement,

HAS DECIDED AS FOLLOWS:

1. The conformity assessment body in Attachment A is added to the list of European conformity assessment bodies under the sectoral chapter for medical devices in Annex I to the Agreement.

2. This Decision, done in duplicate, shall be signed by the Co-Chairs or other persons authorised to act on behalf of the Parties. This Decision shall be effective from the date of the later of these signatures.

Signed in Bern, 17 September 2003.

On behalf of the Swiss Confederation

Heinz Hertig

Signed in Brussels, 2 September 2003.

On behalf of the European Community

Joanna Kioussi

Attachment A

EU conformity assessment body added to the list of conformity assessment bodies recognised under the chapter on medical devices in Annex I to the Agreement

SATRA Quality Assurance Ltd SATRA House

Rockinham Road

Kettering Northamptonshire NN16 9JH United Kingdom Tel. (44) 1536 41 00 00 Fax (44) 1536 52 37 51

Directive 93/42/EEC Medical devices

Responsible for the following products: class IIb male condoms (Annex IV).