Did you know that poor document quality slows down regulatory assessments and regulatory approvals (source)?
And have you heard that regulatory writing impacts the documentation for audits, and building and maintaining a positive relationship with regulatory bodies (source)?
Or are you aware that many notified bodies have reported the technical documentation submitted for conformity assessment lacks half of the required information (source)?
Nailing the technical documentation is essential for any medical device’s regulatory path.
But it can be difficult especially for class I or up-classified devices under the MDR.
Neither of them were subject to much outside scrutiny under the MDD.
Now with the MDR, they are.
Competent authorities are spot-checking class I manufacturers for their MDR implementation. Serious incidents with class I devices will also pull a competent authority to inspect the manufacturer’s state of MDR affairs.
Up-classified devices will be evaluated independently by a notified body under the MDR.
Class I and upclassified devices have the same challenge as everyone else to understand and implement the new MDR regulation. However, unlike many others, they don’t have much experience and set routines of external evaluations. They can easily make mistakes, which might lead to costly delays and interruptions during the MDR journey.
One option I’ve seen helping manufacturers avoid these headaches is to use a support I like to call technical documentation coach.
Next I’m going to tell you more about it and how it can a make the MDR path of class I and up-classified devices easier.
* * * PLEASE NOTE: This post is available also in Finnish Miten teknisen dokumentoinnin valmentaja voi tehdä luokan I ja luokitteluaan nostavien laitteiden MDR polusta helpomman?
What is a technical documentation coach?
In a nutshell, a technical documentation coach helps the manufacturer understand
- what documents are required, and
- how the manufacturer should write them.
By understanding which documents are mandatory, the manufacturer can focus on documents relevant to their device’s MDR risk class and device type. In addition, no important documents will be left out by accident.
With a clear picture of how to organise the documents and what the content should look like, the manufacturer has a better chance of creating documents which meet the needs of the notified body and competent authorities, who use the documents to determine
- whether the device is safe enough to earn or keep a CE mark,
- can the manufacturer pass the audit, and
- in what light they see the manufacturer (“these guys seem to have everything in control” vs. “we need to audit these guys asap!”).
Why would class I and up-classified devices benefit from a technical documentation coach?
Class I devices are self-certified. The manufacturers determine by themselves when the MDR requirements and manufacturer’s obligations are fulfilled and a CE mark can be attached to the devices. When it’s not compulsory to use an external pair of eyes to evaluate MDR maturity, the manufacturers only have themselves to trust.
Even if the manufacturer has a long experience of the medtech market, the MDR is a big learning curve. Manufacturers are expected to provide more evidence of their device’s safety and document it in a more elaborate and precise way.
Up-classified devices refer to devices, which under the MDD didn’t require notified body involvement, but under the MDR they do. The risk classification of these devices goes up from MDD class I to MDR class II typically.
As a result of the up-classification, manufacturers need to start working with an external evaluator (the notified body). This is new to them.
These manufacturers have been used to setting the bar for sufficient regulatory compliance, including technical documentation, internally. The MDR might be the first time an outsider evaluates their regulatory compliance level, including technical documentation.
I’ve often seen firsthand a wide gap between manufacturers’ and notified bodies’ takes on sufficient regulatory compliance. Many manufacturers of up-classified devices need to step up their device technical documentation to achieve notified body approval for the CE mark.
What does a technical documentation coach do exactly?
Technical documentation coach supports the manufacturer’s technical, clinical and other experts who are tasked to create the device’s/devices’ technical documentation under the MDR.
The technical documentation coach complements the documentation team by providing guidance and insight into
- how to write for the target audiences (notified body, competent authorities),
- what templates to use, and
- how to take the MDR technical documentation regulatory guidelines into account.
The goal is to make the documentation work efficient and productive.
In the bigger picture, the technical documentation coach can help the manufacturer to
- get all the necessary documents ready by deadline,
- submit technical documentation to notified body or competent authorities at the agreed time, and
- avoid delays in technical documentation reviews and MDR audits.
Can the technical documentation coach also write the required technical documentation?
Yes, absolutely. The technical documentation coach can step in if the manufacturer doesn’t have the time or resources to write the documentation by themselves.
How I’ve helped my clients as a technical documentation coach?
Class I devices
The challenges – I’ve seen manufacturers have trouble understanding the gap between the MDD and the MDR, what kind of documents the MDR requires, and how they should produce those documents. Manufacturers may have had their CE marked medical devices on the market for years. They want to keep the situation stable and keep the CE mark.
The solutions – First we’ve looked at where they’re now. I’ve walked them through the MDR from their perspective. They have had a chance to ask anything on their mind (and to keep on asking whenever they have had any concerns). I’ve helped them identify relevant documents, organise the content according to guidelines and convert their valuable technical and medical expertise into notified body and competent authority -friendly format. Many times I’ve also taken over the writing. This has been a relief to manufacturers who don’t have the time in their busy schedules or they just don’t enjoy writing.
As a result, my clients have had the relevant documentation completed and available when declaring conformity with the MDR requirements. They can keep on attaching the CE mark to their medical devices. During audits, they have usually got very few non-conformities. If they have received any, they have been able to address them quickly. An up-to-date documentation has helped. They can continue business as usual.
Up-classified devices
The challenges – Manufacturers typically struggle with determining that is their technical documentation good enough under the MDR to get the notified body approval. They want to keep the CE mark, but are often unsure about what they need to do to secure it. ”How should we update the documents”, they often wonder. Manufacturers tend to be aware of the MDR and MDCG guidances, but are uncertain how to implement all the requirements.
The solutions – We focus on looking at the manufacturers’ questions, pain points and frustrations together. Using my experience of working with notified bodies and competent authorities, I guide them to the right direction. Often manufacturers hold a lot of valuable information. It just needs to be presented in a slightly different way than what they’re used to. As a coach I want the manufacturer to get practical MDR confidence. They already have the professional expertise. I’m just helping them present it through the relevant documents in the appropriate manner. If the manufacturer doesn’t have the time to sit down and write for hours or writing is just not their cup of tea, I’ve taken the lead on writing. This has been a relief to manufacturers who prefer a prototype in documentation which they can follow.
As a result, my clients have been able to complete the necessary documents by deadline, submit them to notified body on time, and avoid getting stuck with the notified body evaluations which would put their plans, schedules and CE marking at risk.
Do you need a technical documentation coach?
If you’re looking for an extra pair of experienced MDR hands to help you with technical documentation, feel free to contact me.
Also, if this blog post raised any questions, you’re welcome to get in touch.
I’d be happy to make your MDR path easier.
