EU MDR General Requirements

The transition from the Medical Device Directive (MDD) 93/42/EEC to the Medical Device Regulation (MDR) (EU) 2017/745 introduced significant changes to the regulatory framework governing medical devices in the European Union. The Medical Devices Regulation (EU) 2017/745 (MDR) replaces the Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Devices Directive (90/385/EEC) (AIMDD) in regulating the manufacture, distribution, and handling of medical devices on the EU market.  Significantly more stingent requirements are imposed under EU MDR when compared to EU MDD, especially with the respect to Clinical Evaluation and rigerous monetoring of the safety and performance through the device's lifecycle. 

 

The European Union's Medical Device Regulation (EU MDR) 2017/745 was officially adopted on May 5, 2017, with the original date for full compliance set for May 26, 2020. However, due to challenges such as the COVID-19 pandemic and capacity limitations among Notified Bodies responsible for device certifications, the EU has implemented several extensions to facilitate a smoother transition.​

​

Key Compliance Deadlines and Extensions:

1. Initial Compliance Date:

   • Original Deadline: May 26, 2020​

   • Extension Granted: In April 2020, the deadline was postponed by one year to May 26, 2021, to allow manufacturers additional time to meet the new regulatory requirements. ​

2. Transition Period Extensions:

   • Regulation (EU) 2023/607: Published on March 15, 2023, this amendment introduced staggered transition periods for certain medical devices:​

     • Class III and Implantable Class IIb Devices: Transition period extended to December 31, 2027.

     • Other Class IIb and Class II Devices: Transition period extended to December 31, 2028.

     • Class III Custom-Made Implantable Devices: Transition period extended to May 26, 2026.

3. Removal of the "Sell-Off" Provision:

The original MDR included a "sell-off" date, after which devices compliant with the previous MDD could no longer be sold. However, under the amended regulations, this provision has been removed, allowing such devices to remain on the market indefinitely, provided they meet certain conditions.

​

1. Essential Requirements (MDD) vs. General Safety and Performance Requirements (GSPRs) under MDR:

   • MDD: Outlined 13 Essential Requirements focusing on the safety and performance of medical devices.​

   • MDR: Expands these to 23 General Safety and Performance Requirements, providing more detailed criteria covering the entire product lifecycle, including aspects like risk management, post-market surveillance including continuous Post Market Clinical Follow Up  (PMCF) especially for higher risk devices through these device's lifecycle.

 

​AKRA TEXT>>Since May 26th, 2021, it is mandatory for all medical device manufacturers that want to place or continue to place their device/s on the European market to fully comply with the EU MDR. Transition arrangements may apply to certain manufacturers (Article 120 of the EU MDR) until the 26th of May 2027 and 2028*.