The obligation to apply new regulations regarding medical devices and in vitro diagnostic medical devices, approaching inexorably.

New regulations regarding medical devices and in vitro diagnostic medical devices

The obligation to apply new regulations regarding medical devices and in vitro diagnostic medical devices, approaching inexorably. We would like to remind you that the certificates issued by the Notified Body after 25 May 2017 remain valid for a period not longer than 5 years. However, they lose their validity at the latest on May 27, 2024.

Some important dates

The new Regulation defines some important dates for manufacturers of medical devices, however the first important date of May 27, 2017 has already passed. Certificates that were issued before this date are valid until the end of the period indicated in the certificate.  Medical devices that are covered by these certificates may still be placed on the market or put into service, under pain of meeting certain conditions:

• Products must be compatible with any of the above-mentioned dates from 26 May 2020. Directives.
• The manufacturer has not made significant changes to the design and intended use of the product.
• The requirements set out in the new regulation regarding post-market surveillance, market surveillance, observation, registration of business entities and products will be implemented by the manufacturers in the manner prescribed by the new regulations.

The exceptions are certificates issued for compliance with Annex 4 of Directives 90/385 / EEC and 93/42 / EEC, which expire on 27 May 2022 at the latest.

Another important issue is the stay of products on the market. According to the regulation, devices with certificates issued for compliance with medical directives that have been placed on the market, eg sold wholesalers or pharmacies (it is not required for the product to reach the final user), before and after May 26, 2020 may still be made available on the market or put into service until May 27, 2025.

It should be noted here that these provisions only refer to the sale of new equipment, putting into service for final user. Therefore, the devices purchased by hospital and delivered until May 27, 2025, they can still be in use until the inventory is depleted, but no longer than until the end of their validity.

The above dates apply to devices that have been placed on the market or certified for compliance with Directives 93/42 / EEC and 90/385 / EEC. In the case of medical devices for invitro diagnostics , the transitional periods are longer by two years. The only exception are putting into service or made available on the market those devices that have already been placed on the market. In this case, date of May 27, 2025 is also effective

We invite you to cooperate with PCBC S.A. in the field of certification of medical devices.