Paragraph 5 Amendment to Article 4

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”.