Mastering the complexities of retaining medical device trial records
The challenge of MDR retention and Compliance
According to the medical device regulation (MDR 745), anyone conducting a medical device trial is legally obliged to comply. In the interest of patient health and safety, the MDR states that documents and records relating to medical devices must be retained for a minimum of 10 years, depending on how long the device is available on the market.
To add complexity, time frames also depend on the nature of the device. Throughout this period, it is important that all documents and records are accessible and legible to both staff and regulators.
MDR Retention Risk Management
By not complying with MDR, Medical device manufacturers risk:
- Regulatory fines
- Product recalls
- Reputational damage
- Ability to bring new products to market
Using a validated archiving and preservation solution simplifies documentation management for medical device manufacturers with varying retention requirements. This ensures all documentation is complete and readily available when needed, providing confidence and peace of mind.
Certainty with centralised data.
Transferring medical device documentation to systems or even file sharing platforms such as SharePoint introduces potential risks further down the line. Without appropriate digital preservation measures, there’s a looming threat of loss or corruption, leading to digital illegibility and accessibility over time.
Consolidating all medical device documents and records into a single GCP-compliant archiving and preservation solution offers several benefits:
- Active digital safeguarding and preservation to uphold data integrity in accordance with ALCOA+ principles.
- Compliance with MDR and supporting alignment with ISO 14155:2020
- Simplifies the management and accessibility of your entire portfolio of medical device-related GCP documentation
- Management of audited user access
- Cost-effective long-term solution that avoids vendor lock-in.
GCP-compliant archiving and preservation
Arkivum provides the only validated GCP digital archiving and preservation solution. We support our customers to adhere to long-term retention regulations such as MDR, by ensuring that records are available, accessible and legible for as long as they are needed. Our solution is aligned to the ALCOA+ principles both now and in the future.
Find out more about some of the key features of our solution below.
Regulatory Compliance Features
Managing documents and records for medical devices poses challenges due to the varying retention requirements, starting with a minimum of 10 years. Arkivum provides a suite of tools to help manufacturers align with regulation e.g. retention rules and legal holds.
Data Preservation
In the face of rapid technological evolution, medical device manufacturers require assurances that their documents and records remain accessible and legible for over 10 years. To ensure you stay ahead, Arkivum’s digital preservation tools automatically retain copies in long-term formats, guaranteeing legibility for as long as necessary.
Migration Service
Arkivum’s validated migration service takes the stress away from moving data. Our experienced migration team specialises in transferring large volumes of technical documentation from multiple sources. Customers maintain control and oversight with minimal effort on their part.
MDR Retention and Compliance FAQs
What is a medical device?
MDR 745 changed how the EU classifies medical devices and, perhaps most importantly, expanded the definition to include more than had previously fallen under the Medical Device Directive. For example, MDR now includes certain aesthetic devices that have the same or similar characteristics and risk profiles as other medical devices which were previously covered.
MDR also classes medical devices differently based on their risk profile, and also whether or not the clinical investigation is invasive or just observational. What is important to note, is that many devices are now covered within the regulation that hadn’t previously fallen under the MDD, so it’s important to take note of whether this applies to you and your organisation.
Does Arkivum support organisations in complying with MDR 745?
Yes, the Arkivum solution supports organisations to align to the retention requirements of MDR 745. MDR states that documentation relating to that medical device, must be retained for at least 10 years after the device was last placed on the market (15 years in the case of implantable devices).
The Arkivum solution ensures that data is finable, accessible and legible for as long as required.
Do you have any guidance on the retention requirements for MDR 745?
Yes, Arkivum published a blog post on the topic here.
How does Arkivum support my alignment with ISO 14155:2020?
While Arkivum is not certified in ISO 14155:2020, our solution supports organisations with good documentation practice, alignment with GCP principles and, ultimately, their efforts to adhere to this standard.
Why can’t I store my medical device documentation in SharePoint (or another file-sharing platform)?
File-sharing platforms such as SharePoint are not designed to archive and preserve data for decades or longer. They do not have digital safeguarding and preservation capability to ensure that data remains accessible and legible for the entire retention period.
Arkivum highly recommends that any organisations responsible for retaining medical device documentation migrate these records into a dedicated long-term archive or repository.
Are wearables included within the scope of MDR?
The answer depends on the type and use of the wearable and the data that it is generating (and where it is going). It’s a complex field, and if you have data retention requirements relating to wearable devices, please contact us here.
Where is my data stored?
The Arkivum solution is hosted on Amazon Web Services (AWS). We typically store customers’ data in a minimum of two separate geographic locations, aligned with a customer’s data sovereignty requirements. An optional third escrow copy can be stored with Microsoft Azure if required.
How do I access and manage the Arkivum solution?
The Arkivum solution is managed through an online browser-based dashboard. It supports the majority of modern browsers such as Google Chrome and Microsoft Edge.
Can you set retention policies for records and files?
Yes, it is possible to set retention policies in place within the systems. It is also possible to place legal holds on these periods if required.
How do I know if my data has become corrupted?
Whenever a data integrity check is conducted (called a fixity check), the system uses a checksum to compare each to how the original looked when it entered the archive. The results of these checks (including any errors) are reported within the fixity report within the system.
How long does it take for customers to be onboarded onto the solution?
Arkivum can work within customer timelines to onboard as quickly as they need. There are several steps required to set up a new system and train staff on its use, but we are confident that we can meet all customer timelines for onboarding.