AIIM Open Forum

New Changes to the European Union's Medical Device and In Vitro Diagnostic Device Regulations

By Heather Rice posted 01-20-2021 13:11

  

On May 26, 2020, the European Union enacted new regulations concerning medical and in vitro diagnostic devices—a move that should cause manufacturers, clinical trial sponsors, investigators, and other regulated parties involved in medical device development, manufacture, and distribution in the EU to take notice. These new regulations replace existing directives and bring about many changes, including important changes to records retention periods.

Medical Device Directive 93/42/EEC has been replaced by Medical Device Regulations (EU) 2017/745. This regulation applies to both implantable medical devices and non-implantable medical devices.

In Vitro Diagnostics Regulations (EU) 2017/746 replaces In Vitro Diagnostic Medical Devices Directive 98/79/EC. Although this new regulation is not fully effective until 2022, certain articles are already in force.

Below is a summary of the changes to the retention periods and new requirements that are included in these regulations.

Details of Changes to Retention Periods

 Medical Device Regulations (EU) 2017/745:

  • Technical documentation, declarations of conformity, and any relevant certificates: For manufacturers, authorized representatives, or importers of medical devices, the retention period for these documents has been increased from 5 to 10 years after the last device has been placed on the market. When these documents relate to implantable devices, the retention period is 15 years after the last device has been placed on the market (the same as under the prior directives).[i]
  • For persons combining medical devices with other devices: The retention period for records compatibility, packaging, and internal monitoring verification statements has been increased from 5 to 10 years after the last device has been placed on the market, or 15 years after the last implantable device has been placed on the market, whichever period is longer.[ii]
  • Economic operators (including manufacturers, authorized representatives, importers, and distributors) of medical devices: These parties are responsible for keeping supply chain records for the same 10-year and 15-year requirements described in Article (10)(8) of the new regulations.[iii]
  • (Annex IX)(7) and (Annex X)(7) require manufacturers (or their authorized representatives) to keep EU declarations of conformity, quality management system documentation, data and records which arise from procedures for monitoring, verifying, validating, and controlling design, technical documentation, and similar records for a period of 10 years after the last device has been placed on the market. This retention period also applies to decisions and reports from the notified body. This is an increase of 5 years to the retention period. These same documents, as they relate to implantable devices, must be kept for 15 years after the last device has been placed on the market.
  • (Annex XI)(9), (10.5), (17) and (18.4) require a 10-year retention period for medical devices and a 15-year retention period for implantable medical devices for the following records: EU declarations of conformity, quality management system documentation, post-market surveillance system documentation, decisions and reports from the notified body, manufacturing process documentation, and EU product verification certificates, among other similar records.
  • Manufacturers or authorized representatives of custom-made devices must retain statements containing specifics which identify the device, the intended use of the device, characteristics of the product (as indicated by prescription), and general safety and performance requirements, along with similar information, for 10 years after the device has been placed on the market. This same information must be kept for 15 years if it relates to implantable devices.[iv]
  • Lastly, sponsors of clinical trials for medical devices must retain documentation, including application forms, investigators’ brochures and performance study plans, for 10 years after the device’s clinical investigation has ended. If the device is placed on the market, these documents must be kept for 10 years after the last device has been placed on the market. The retention period for implantable devices is 15 years.[v]

In Vitro Diagnostic Regulations (EU) 2017/746:

  • Technical documentation, declarations of conformity, and copies of all relevant certificates: Manufacturers, authorized representatives, and importers of in vitro diagnostic devices must now retain these documents for 10 years after the last device has been placed on the market. This change increases the retention period by five years.[vi]
  • Economic operators (including manufacturers, authorized representatives, importers and distributors) of in vitro diagnostic devices are responsible for keeping supply chain records for the 10-year retention period noted in Article (10)(7) of these new regulations.[vii]
  • (Annex IX)(6), (Annex X)(6) and (Annex XI)(6) require manufacturers (or their authorized representatives) to keep the following records for 10 years after the last device has been placed on the market:
    • any EU declaration of conformity;
    • quality management system documentation;
    • documentation of procedures and techniques for monitoring, verifying, validating and controlling design;
    • technical documentation;
    • copies of EU type-examination certificates; and
    • certain similar documents.
  • Lastly, (Annex XIV)(Chap II)(3) requires sponsors of clinical trials for in vitro diagnostic medical devices to keep application forms, investigators’ brochures, and performance study plans (along with similar documents) for 10 years after the end of any clinical performance study. If the device is placed on the market, the retention period becomes 10 years after the last device has been placed on the market.

Impacts from These Changes 

If you are regulated by the European Union, be sure to update your retention periods for the relevant categories of records. If you need assistance in setting up or updating your retention schedule, contact Zasio.

[i] Medical Device Regulations (EU) 2017/745 (10)(8), (11)(3)(b) and (13)(9).

[ii] Id. at (22)(5).

[iii] Id. at (25).

[iv] Id. at (Annex XIII)(4).

[v] Id. at (Annex XV)(Chap III)(3).

[vi] In Vitro Diagnostic Regulations (EU) 2017/746 (10)(7), (11)(3)(b) and (13)(9).

[vii] Id. at (22).

Disclaimer: The purpose of this post is to provide general education on Information Governance topics. The statements are informational only and do not constitute legal advice. If you have specific questions regarding the application of the law to your business activities, you should seek the advice of your legal counsel.

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