FAQ

- close cooperation between MAH and the API manufacturer

- close cooperation between MAH and the manufacturer of the final product

- solving production procedures and all risk points in the production flow in the sense of preventing the formation of nitrosamines

- monitoring of Appendix 1 and evaluating risk molecules in connection with it

- implement limits on the content of nitrosamines into specifications in justified cases

- work closely with the relevant authorities

- prevent the unavailability of medicines due to the content of nitrosamines

- follow the relevant regulations, which are regularly updated

Although the MDR came into force on 25/05/2017 and defined a transition period different by risk class, it was finally amended by Regulation (EU) 2023/607 to provide a sufficiently long period to carry out the conformity assessment of the medical devices in question. The extended transitional period, even after 26.5.2024, can be used for legacy devices that are still in compliance with Directive 93/42/EEC and have not undergone significant changes in design/purpose of use, as follows:

• until May 26, 2026 - custom-made class III implantable devices
• until 31.12.2027 - Class III and implantable IIb devices (except for suture materials, clamps and staples, dental fillings, braces, crowns, screws, wedges, plates, wires, pins, clips and connectors)
• until 31.12.2028 – other resources of class IIb, IIa, and classes Im and Is and resources requiring the involvement of a notified entity newly 
  under the conditions:
  • implementation of a quality management system (QMS) in accordance with the MDR by 26.5.2024, and 
  • submission of a formal application for assessment of conformity according to the MDR to the notified body by 26/05/2024, and
  • signing an agreement with a notified body on conformity assessment according to the MDR by 26.9.2024.