New rules for the electronic submission of notifications and notifications and the transmission of documents relating to EU Regulations 2017/745 and 2017/746

As of 12 December 2020, the revised rules for the notification and notification of medical devices apply. The most important thing from the perspective of entrepreneurs operating in the medical device market is the introduction of the possibility of submitting notifications and notifications by electronic means. Application and notification forms may be submitted to the Office in electronic form in an electronic inbox of the President of the URPL, after they have been provided with a trusted signature, personal signature or qualified electronic signature.

It is important that the change applies only to the form of notifications and notifications, and the remaining requirements remain unchanged. This means that the notification or notification must be accompanied by all the required documents (as referred to in Article 10(1) of Regulation (EC) No 1782/2003). Whereas article 59 (2) of the Treaty provides that the community may Article 2 and Article 2s shall apply mutatis mutan Whereas article 60 (2) of the Treaty provides that the community may 2 of the Medical Devices Act), i.e. m.in. models of marking and specimens of instructions for the use of the device, as well as forms in xml files.

The current ways of making notifications and notifications remain valid. Forms can still be submitted by post or submitted to urpl headquarters in paper form and in the form of an electronic document.

In addition, in view of the forthcoming date of the new EU Regulation on Medical Devices No 2017/745 in its Communication of 22 December 2020. (available on the Office's website: http://urpl.gov.pl/pl/komunikat-prezesa-urz%C4%99du-z-22-December-2020-r-on-electronic-sk%C5%82adania-zg%C5%82oze%C5%84-i) The President of the Office has explained in detail the situations in which a new notification or notification should be made and in which it will be sufficient to inform about the amendments.

According to the Communication on products for which an assessment of compliance with Council Directive 90/385, Council Directive 93/42 or Council Directive 98/79 has already been carried out, and subsequent evaluation on the basis of the new Regulation of the European Parliament and of the Council (EU) 2017/745 and 2017/746, there is no obligation to submit new notifications or update them. Exceptions to this rule shall be cases where the name or address of the notified entity or authorised representative is changed and must be reported to the Office.

On the other hand, in the case of notifications concerning:

  • product which has not previously been placed on the market, a new notification must be made together with a fee;
  • a product which has previously been placed on the market (in accordance with Directive 90/385, Directive 93/42 or Directive 98/79) should be informed of the amendments pursuant to Article 10(1) of that Directive. Article 61a of the Medical Devices Act.

It is important that, where a conformity assessment results in a change in the class of the device, a new notification must be made.

On the other hand, if there is a change:

  • the name or address of the manufacturer, which is not accompanied by a change in the KRS or REGON number,
  • the name or address of the authorised representative,
  • the trade name of the product,
  • the number of the notified body which was involved in the conformity assessment,

amendments to the data covered by the notification must be not reported to the Office.


KONDRAT law firm and Partnerzy
biuro@kondrat.pl

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