Before you begin (or continue your EU MDR Journey), make sure you’re operating off of comprehensive templates. This article will cover a brief overview of our own templates (some free, some paid), and include links to download whichever would be the most helpful for you team.
A word of caution: not all templates are created equal.
Before we just give you the files, I think it’s important to review a few tips and guidelines for how to assess the templates you use. Whether you go with our free or paid templates, or buy one somewhere else we want to at least leave with you some actionable methods of evaluation.
Have Your EU MDR Templates Been Successful?
Reading the regs is one thing, actually submitting and traversing the (sometimes complex) audit process successfully with your medical device is another thing entirely.
Whichever templates you go with, I would confirm with the authors that they have actually used them on submissions. Anyone can throw together a template based on the regs or guidance documents, but few are actively submitting their drafts each months like we are.
Our team has performed 100s of cumulative submissions (across CERs, PERs, PSURs, and more) with success. Each time we get feedback, we incorporate it into our templates and update them. We are no strangers to medical device technical files and our templates benefit from that experience.
Have You Read the Recent Guidance Docs?
A great way to cause pain during your audits is to have missed a Guidance document that clearly defines the template. Make sure you glance through the guidance docs to be certain that something specific to your device or document drafts hasn’t been released.
There’s no need to re-invent or re-purchase the wheel, if and MDCG guidance doc gives you everything you need.
When it comes to Clinical Evaluation, there currently isn’t a ‘template’ available, but the rules for how a Notified Body will evaluate your CER is defined in a guidance document.
Will an EU MDR Template Fix Your Audit Woes?
In short, no. Despite what some more aggressive marketers might tell you, a great template will not compensate for lack of medical writing skills, device knowledge, or previous regulatory technical file submission experience.
Medical Device technical files are not as simple as plug a worksheet to be filled out. Complex decisions must be weighed when it comes to your Safety and Performance claims, and an intricate argument needs to be woven in with your risk management policies in order to convince a Notified Body of your product’s safety and company’s commitment to maintaining it.
By all means start off on the write foot with a template and/or an example (In our paid templates, we include fully worked examples of the CER for your reference), but if this is the first time you are writing any kind of medical device technical file document, be warned that it’s not going to go smoothly.
If you’re still deciding on whether or not to tackle the work yourself, we’re here to help with some quick and free advice anytime. You can drop us a line here to chat about your active device.
Buy Your EU MDR Templates, or Download A Free Template?
We say to pay for them if you can afford them. A few hundred dollars in exchange for savings 10-20 hours drafting your own from the Regs seems like a no-brainer value.
But, if you’re a freelancer just starting, or a small manufacturer strapped for cash, then even $300 extra might tip your budgets.
We get it. That’s why we’ve been on a mission to offer as much free content for the ‘do it yourself’ Regulatory Superheroes out there. We give away more free stuff, and at a higher quality than most Regulatory firms’ paid information.
So, if you have a little budget, our premium templates will save you time, guaranteed. If you don’t, then you can absolutely get it done with our free templates and instructional content.
Either way, do your homework. Your technical file will thank you down the line when the audits come.
A Look at Our EU MDR Templates for Medical Devices
We have several templates available, and some more in-depth packages for the more thorough medical writers.
The Clinical Evaluation Report (CER) Template
The big Kahuna document. The CER is where the meat of your presentation, analysis and discussion of clinical evidence (and adverse events/complaints) comes into play. This is where you’ll construct your argument. Your intended purpose, intended use, safety and performance claims are all discussed in detail here. And don’t forget to tie in your risk management plan here!
The CER References many other documents in your medical device technical file, and needs consistent maintenance (annually or every two years depending on device classification).
If you do spend on a template, we recommend the CER because the format and sections are drastically different from the MDD days. Your old template retrofitted simply will not pass when the Notified Bodies review your technical file.
The Clinical Evaluation Plan Template
Tied in directly with your Systematic Literature Review, the CEP document is an essential requirement for outlining exactly how you plan to keep your Clinical Evaluation data updated and assessed in the coming years.
The Literature Review Protocol and Template
Currently assessed under Meddev 2.7.1 Rev 4 as of this writing, the Literature Review is a critical component of your MDR submission that wasn’t very scrutinized under MDD.
The Periodic Safety Update Report Template
For Class iia, iib and class iii, your PSUR contains the brunt of your Post Market data and trending analysis. Required every 1-2 Years, it’s a far more robust document than the PMS Reports of MDD days that you probably snoozed on submitting.
While not nearly as involved as the CER in structure, it’s the data wrangling that will take the most time for preparations and is still an important component of your technical file submission. Don’t forget, that an initial PSUR that covers the lifetime of the device should be submitted initially when filing.
The Post Market Clinical Follow-Up Plan and Report
PMCF is far more tailored to the manufacturer, therefore a straight template will not solve all your regulatory decision making problems. The details of the plan need to be specific to the device, and actually attainable for the reports. If you plan to send PMCF Surveys, then you better be sure you have a plan to actually collect the data and display it in the updates. Device incorporating software or AI components should pay careful attention to this template.
Templates Download Link:
You can get everything by joining our community of medical devices regulatory pro’s (it’s free). Fill out the quick form here, and check your inbox for all of our info, templates included.
Are You On Top of your Medical Device Technical File?
If you are still brand new to drafting medical device technical files and unfamiliar with the components, you may benefit from going through an EU MDR Readiness checklist process, before jumping into the templates.
If you’re new, read on and get a bit more background on MDR plus access to our readiness checklist for new manufacturers.
The New EU MDR Regulations for Medical Devices: Are You Ready?
The MDR was published in the EU Official Journal on 5 May 2017 and comes into force after a transition period on 26 May 2021.
The MDR reflects a more risk-based approach to medical device regulation, which is designed to ensure a higher level of protection for patients while maintaining the high standards of quality and safety that are already in place in Europe.
The new EU MDR has a higher bar for safety and risk management requirements than previous regulations.
Manufacturers are required to maintain an extensive quality management system (QMS) in place for post-market surveillance and vigilance reporting, as well as comprehensive technical documentation that demonstrates adherence to all applicable requirements throughout the device’s lifecycle.
Why do you need an EU MDR checklist?
The EU MDR revision is a sweeping change to the regulatory landscape for medical devices in the EU. It will replace and consolidate several existing Directives. The impact of the new Regulation is significant, particularly on combination products, reprocessing software, and custom-made devices.
Importantly, it will result in significant increases in industry compliance costs.
There is a transitioning period, but the preparation needed to comply with MDR will require most of this time.
This means that manufacturers will have to re-evaluate their entire product portfolio and update documentation and processes as necessary to comply with the new requirements.
As a result, many firms are now coming to grips with what they need to do to ensure compliance with the EU MDR and maintain European market access beyond May 2021.
An EU MDR readiness checklist can help companies assess what they have already done and what they still need to do in order to become compliant with the new requirements. The checklist covers the essential MDR-related tasks, So it is a list of all actions that may be necessary for your product’s MDR approval.
Download your MDR readiness checklist here!
What is GSPR in MDR?
GSPR stands for General Safety and Performance Requirements. Within the new European Medical Device Regulation (MDR) there are 23 requirements that make up the GSPR requirements.
The GSPRs is essentially a list of requirements manufacturers need to follow in order to guarantee the safety and performance of their devices. These requirements include things such as device design, usability, sterilization, labeling, and packaging.
What is a GSPR flash audit?
GSPR flash audit is an inspection of your Quality Management System (QMS) or part of your QMS, to verify that you are compliant with the requirements of the IVDR, MDR, and GSPR.
GSPR requires medical device manufacturers to conduct these annual audits.
The purpose of the audit is to ensure that the manufacturer’s quality management system complies with the new requirements of the EU MDR.