EU MDR 2017/745

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European Parliament

Medical Devices Regulation (EU) 2017/745 – MDR

EU MDR

Two new medical device regulations were issued on May 5, 2017, and they became effective on May 25. If the transitional arrangements do not permit the continuous placement of devices on the market, compliance with the Medical Devices Regulation (MDR) is required as of the date of application, which is May 26, 2021.

 

As of May 26, 2022, the In Vitro Diagnostic Medical Devices Regulation (IVDR) is in effect.

 

The UK government's new product marking UKCA, which went into effect on January 1, 2021, must be adhered to by all goods intended for the UK market. The UKCA transition time for medical devices is presently planned until 30 June 2023.

 

Medical Devices Regulation (EU) 2017/745 – MDR

The In Vitro Diagnostic Directive (IVDR) will replace the In Vitro Diagnostic Directive (IVDD), whereas the Medical Devices Regulation (EU) 2017/745 has replaced the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD) (IVDD). Both regulations make a number of significant advancements in the conformity evaluation process for medical devices with the following goals:

 

  • Improve the medical devices that are sold in Europe in terms of their quality, reliability, and safety.

  • Boost consumer and professional access to information about medical devices by increasing transparency.

  • Become more vigilant and keep an eye on the market for used equipment.

The sort of medical devices made and the responsibilities you hold will determine how much these changes will impact your operations (manufacturer, importer, authorized representative). However, it is anticipated that before compliance with the regulations can be achieved, significant changes will typically need to be made to the compliance process, quality management system, and technical documentation and successfully implemented, as well as certified as relevant to device classes and roles of your organization.

 

Validity of MDD certificates

MDD certificates are valid until the earlier of their original expiration date or May 26, 2024. This is provided that compliance is upheld, specific MDR requirements are met, and the Notified entity engages in surveillance operations.

 

Therefore, producers may continue to market MDD-certified products through May 26, 2024, inclusive. But it's vital to remember that after May 26, 2020, there won't likely be any significant adjustments made to MDD-certified devices. The device certificate must be moved to MDR if a significant change is necessary.

 

Migration of MDD certified devices to MDR

The modifications to the MDR and IVDR are frequently viewed as an update to the specifications. It should be seen as a new regulation as that is what it actually is. While there have been substantial revisions and additions to the new legislation, the general ideas and requirements of the MDD and IVDD are still included. Before manufacturers may submit an application for certification to the MDR and IVDR, they must take care of a number of new requirements.

 

The lawful manufacturer must submit a fresh application for certification, which will start a new certification cycle with a maximum 5-year validity. Before certification is awarded, manufacturers must successfully complete a Notified Body examination of technical files and an initial on-site audit activity to ensure implementation. Sampling is used to review technical files, although Class IIb implantable devices and Class III devices cannot use this method. Prior to application, manufacturers must confirm that their technical papers and design dossiers comply with MDR.

 

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