Warning for distributors and suppliers of medical devices

The end of the deadline for notification of the medical devices is approaching

Dear Distributors and Suppliers of Medical Devices, with the adoption of the new Act No. 268/214 Coll., On Medical Devices and amending Act No. 634/2004 Coll., On Administrative Fees, the agenda for the notification of medical devices was transferred to a new unified system for complex data management in the field of medical devices. The Medical Device Register (RZPRO) serves to collect data on:

  • persons registered under this Act,
  • medical devices placed on the market in the Czech Republic,
  • adverse events and safety remedial measures,
  • clinical trials of medical devices,
  • performed assessments of the functional capability of medical devices and
  • certificates issued by Notified Entities established in the Czech Republic.

We would like to draw your attention to the termination of the transitional provision concerning medical devices of Class IIa, which is referred to in Section 97 of the Transitional Provisions in paragraph:

(5) Distributor or importer who has fulfilled his obligation of reporting pursuant to Act No. 123/2000 Coll. and intends to continue to place on the market in the Czech Republic a medical device which it introduced or supplied to the Czech Republic before the date of entry into force of this Act and which is subject to notification under § 33, it is obliged to submit a request for notification of this medical device at the latest to

1 year after the effective date of this Act in the case of a Class III medical device or an active implantable medical device,
2 years from the effective date of this Act in the case of a Class IIb medical device or an in vitro diagnostic medical device belonging to List A or B,
3 years from the effective date of this Act in the case of a medical device of Class IIa or a self-testing medical device
(6) The application submitted pursuant to paragraph 5 shall be decided by the Constitution no later than 90 days from the date of filing the application.

Since Act No. 268/214 Coll. on medical devices acquired pursuant to Section 104 effective on April 1, 2015, expires the validity of the notification of the Class IIa medical device on 1 April 2018. It is therefore necessary to submit an electronic application for the extension of the notification of the medical device through the register of medical devices before the expiry of this period.

We will be happy to assist you with the whole agenda of extending the notification of medical devices. In addition, we can provide you with a follow up of the expiration of the notification period of medical devices with your other medical devices so that you can meet all the required legislative requirements smoothly.

Best regards, MeDeCorp s.r.o.