This week we conducted a training on MDR regulations.  Hitec Medical is applying for MDR CE certificate and estimate to get it next May.

We learned about the development process of MDR regulations.

On May 5, 2017, the Official Journal of the European Union officially released the EU Medical Device Regulation (MDR) 2017/745.

The purpose of this regulation is to ensure better protection of public health and patient safety. MDR will replace Directives 90/385/EEC (Active Implantable Medical Device Directive) and 93/42/EEC (Medical Device Directive). According to the requirements of MDR Article 123, MDR officially came into effect on May 26, 2017 and officially replaced MDD (93/42/EEC) and AIMDD (90/385/EEC) on May 26, 2020.

Due to the impact of the COVID-19, the notice on the revision of the MDR date of the new EU regulation MDR on April 23, 2020 officially announced that the implementation of the MDR was postponed to May 26, 2021.

Starting from May 26, 2021, all medical devices newly launched in the European Union must comply with MDR requirements.

After the implementation of MDR, it is still possible to apply for CE certificates according to MDD and AIMDD during the three-year transition period and maintain the validity of the certificates. According to Article 120 clause2, the CE certificate issued by NB during the transition period shall remain valid, but shall not exceed 5 years from its delivery date and shall expire on May 27, 2024.

But, the progress of MDR has not been as smooth as expected, and the current policy is as follows,

Before May 26, 2024, enterprises must submit an application for MDR to their notified bodies, then their MDD certificates (IIb, IIa, and I devices) can be extended up to December 31, 2028.