Paragraph 5 Amendment to Article 4I1

Article 4 (obligations of suppliers in relation to the product database) is amended as follows.

In the heading, for “the product database”, substitute “ product information ”.

Omit paragraph 1.

For the first and second subparagraphs of paragraph 2, substitute—

“2

Where units of models covered by a delegated act are placed on the market the supplier must make an electronic version of the technical documentation available for inspection within 10 days of a request received from market surveillance authorities.”.

Omit paragraphs 3 and 4.

In paragraph 5, for “obligations referred to in paragraphs 1 and 2”, substitute “ obligation referred to in paragraph 2 ”.

For paragraph 6, substitute—

“6

After the final unit of a model has been placed on the market, the supplier shall keep the information concerning that model for a period of 15 years unless, where appropriate in relation to the average life span of a product, a shorter retention period is specified pursuant to Article 11A(4)(p).”.

After paragraph 6, insert—

“7

For the purposes of paragraph 2, technical documentation includes but is not limited to—

(a)

a general description of the model, sufficient for it to be unequivocally and easily identified;

(b)

references to the designated standards applied or other measurement standards used;

(c)

specific precautions that must be taken when the model is assembled, installed, maintained or tested;

(d)

the measured technical parameters of the model;

(e)

the calculations performed with the measured technical parameters;

(f)

the conditions of testing that must be applied, if not described sufficiently in point (b);

(g)

the model identifier of all equivalent models already placed on the market.

8

On request, suppliers must provide any data not specified in paragraph 7 to the market surveillance authorities which is necessary for those authorities to carry out their tasks under this Regulation”.