Ofa Bamberg Info Sheet

Listing Results Ofa Bamberg Info Sheet

Frequently Asked Questions

• What is the OFA?

  What Are the Health Statistics for My Breed? What Health Screening Results are Recorded in the OFA Database? Founded in 1966, our mission is to promote the health and welfare of companion animals through a reduction in the incidence of genetic disease.

• Is the information on the OFA website copyrighted?

  All information displayed on the OFA website, including search results from the OFA database, is copyrighted property of the OFA. Any type of public reproduction is strictly prohibited without the express permission of the OFA.

• Where can I find information about OFA Cardiac certification programs?

  The OFA website and databases provide the tools, whether you are a veterinarian, breeder, or prospective owner. Effective October 1, 2020, several changes will go into effect regarding the cardiac certification programs administered by the OFA.

• What are the MDR's new regulations for medical devices?

  Distributors now have to verify that the medical devices they sell meet the defined requirements as outlined in Art. 14 of the MDR. Among other things, distributors must check whether the medical devices are CE-marked and have a valid declaration of conformity.

• What are the responsibilities of distributors under MDR/iVDR?

  The Regulations describe the roles and responsibilities of distributors in MDR/IVDR Article 14. (For more information see also: ‘Blue Guide’ on the implementation of EU product rules.) Distributors should make sure, by representative sampling, that the devices they distribute are compliant with the obligations described in MDR/IVDR Article 14 (2):

• Can a distributor put a medical device on the market?

  In case a distributor has reason to believe that a device is not in conformity with the requirements of the new regulation, he is not allowed to put the devices on the market. Another rather interesting element of the Medical Device Regulation is that the outlined verification obligations make distributors some sort of “controlling authority”.

• What is the purpose of the Medical Device Reporting Act?

  ( a) This part establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors.