Arkivum recently hosted a webinar with Stuart McCully, on the impact of the new medical device regulation (EU regulation 2017/745 or often simply referred to as MDR 745). The session explored ‘the penalties, challenges and solutions associated with medical device clinical investigation records management’.
As a follow up to that session, I wanted to write this blog post to focus on the retention requirements outlined within MDR 745 and explore some of the main considerations organisations need to make to stay compliant, both now and in the future. Also, as a side note if you are interested in watching a recording of the above mentioned session you can do so by clicking here.
What is MDR 745?
MDR 745 replaced the previous Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) and was created primarily ‘for a more patient-centred healthcare where transparency and patients’ information and choice are a priority, and where patients can benefit from innovative, high-performing devices and new therapies1’.
This change to MDR saw the switch from a set of directives for EU member states to a regulation with minimum requirements that medical device sponsors and manufacturers need to adhere to.
The regulation was published in May 2017 (hence the reference in the name) and came into effect four years later on the 26th May 2021. Any medical device placed onto the European market past that date must adhere to the new regulation (bar any special arrangements being made prior).
It is also worth referencing the related in vitro Diagnostic Medical Devices Regulation (IVDR) that was published alongside the MDR in 2017 but only came into effect in 2022. As the name suggests, this relates to in vitro diagnostic devices and for the purposes of this blog post we’re going to leave IVDR here for now. I would, though, be interested to hear if you have any interest in hearing about this in future.
What is a medical device?
It might seem like an obvious question, but MDR 745 brought changes to how the EU classifies a medical device, and perhaps most importantly expanded the definition of a medical device to include more than had previously fallen under the MDD. 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.
The new regulation also classes medical devices differently based on their risk profile, and also whether or not the clinical investigation is invasive or just observational. The webinar with Stuart covers this in much greater detail, but for now I want to focus more closely on the documents and their retention requirements.
What is important to note from this section, 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.
MDR 745 record retention requirements
Switching now to look more closely at the retention requirements of MDR 745, we first need to look at which documents need to be retained. On the face of it, the regulation requires organisations to keep the documents referenced within Annex XV which include:
- Application form
- Investigator’s Brochure (IB)
- Clinical Investigation Plan
- Clinical Investigation Report
- Other documents (e.g. Technical Documentation, Regulatory Authority (RA) and Ethics Committees (EC) Approvals etc.)
But it doesn’t stop there. Organisations are also required to not only run their investigation in line with Good Clinical Practice (GCP) but be able to provide evidence that they have done so.
It’s worth highlighting here that medical device GCP shouldn’t be confused with drug clinical trial GCP guidelines (as outlined by the ICH); it is distinct from drug development and is outlined within ISO 14155:2011. One of the main differences being that it includes guidance on observational investigations which are not included within the ICH’s GCP (which focuses solely on interventional).
This set of documentation includes a wide range of records from before, during and after the trial, such as the CVs of the principal investigator and their team, EC voting lists, subject screenings and the sponsor’s statistical analyses. There are more but I would recommend reviewing ISO 14155 in more detail for the full list.
All of these records must be kept in line with the MDR retention requirements.
So how long should these records be kept?
The simple answer is it depends. Every clinical investigation for a medical device must retain its documents for at least 10 years regardless of whether it has gained approval or not (apart from Bulgaria which stipulates 20 years). For devices which are approved, there are three main categorisations:
- Implantable devices in which the records need to be kept for at least 15 years after the last device is placed on the market.
- Non-implantable device in which the records need to be kept for at least 10 years after the last device is place on the market.
- Combination products which require a double approval also need to take into account the 25-year retention required as part of EU Regulation 2014/536. You can read more about what I have written on that regulation here.
One of the first questions you may ask in relation to these requirements is what exactly does ‘last device placed on the market’ actually mean? Fortunately, there has been recent guidance given on this point in a periodic safety guidance update document in December 2022 which stated that this phrase can be taken as ‘The overall lifetime of a device (model) should include the time between the placing on the market of the last manufactured device and the end of the intended lifetime of that (individual) device’2.
For the majority of approved investigations, it’s important to note that at the point of approval you’re unlikely to know how long you will ultimately need to retain these records for.
I’m going to finish this post now by highlighting some of the key considerations to make when planning how best to retain your medical device documentation.
Archiving medical device documentation
When storing digital records for more than 10 years, it’s important to start considering how you will safeguard and preserve those documents for the entire retention period. A major part of this is ensuring that you have the right technology and processes in place to guarantee long-term access, availability, and use.
At the conclusion of a clinical investigation, migrating your data into a dedicated and separately managed archive can ensure that your records will stand the test of time. Keeping records in other systems can put them at risk of corruption, limited future access and software and hardware obsolescence.
A digital archive can mitigate these risks by;
- Storing multiple copies of each record in geographically different locations.
- Automatically checking for corrupted data on a regular basis and resolving as necessary.
- Assigning advanced metadata to each file to ensure records can be easily found in future.
- Maintaining records in long-term formats to be easily opened, read and used on future devices and software.
- Managing access through authorised personal, whose actions within the archive are captured within an audit trail.
In our experience, we have also found that retaining clinical records within a purpose-built digital archive is significantly more cost effective than storing them within the existing systems used by our customers.
I hope you’ve found this blog post useful. If you are interested in speaking to me or one of the team about anything that I have covered in this post, please do not hesitate to contact me at Tom.Lynam@Arkivum.com.
26 Jan, 2023
Webinar Recording: The Impact of the New Medical Device Regulation on Records Managers
16 Feb, 2023
4 reasons why your eTMF solution is not a viable digital archive
16 Jan, 2023