It can be a scary thought, regulatory compliance. So much to get your head around, so much to make sure is done right, and what is “right” anyway.
Wouldn’t it be handy to have a “crib sheet” to help you get there with less pain, in a shorter time, whilst simultaneously supporting development of a good medical device.
1. The right regulation?
May sound a bizarre first step, yet it is surprising just how many projects don’t adequately consider this question.
- Be clear about the primary purpose for your medical device, and the mode of action.
- Then, check the definition of “medical device” in the MDD (Article 1, 2 (a) through to (c)).
- Does your product fit the description of a medical device? If, yes, then the MDD applies.
- Does your product fit the description of an in vitro diagnostic device? If yes, then the IVD applies.
- Does your product clearly not fit with any of the descriptions? You can get advice (in the UK) from MHRA on borderline cases. Similarly, you can access EU wide borderline device decisions, and the reasoning.
Remember to also consider other EU legislation that your product may need to comply with. And, if you have an eye on other markets, look at how their requirements may differ from those of the EU.
2. Are you setting out to solve the right problem?
What is the problem or clinical need that your product is intended to resolve? Is the problem widespread or isolated to a small aspect of healthcare in one country?
Answering this question will clarify the potential market size and clinical pathway(s) where the device can be used. Your focus is then narrowed onto developing a product to address a specific need. You can always expand into other clinical pathways or markets with a future version of the product.
Ultimately, you’ll have started to flesh out the product’s “Intended Use”, the bedrock upon which development rests. Get this right, and the foundation is secure.
3. Put a Quality Management System in place
Arrival of the Medical Devices Regulation (MDR) explicitly requires a Quality Management System to be put in place for all classes of Medical Device.
The difference between the lowest risk medical devices and the higher classes is one of QMS certification. For the Class 1, non-measuring, non-sterile medical devices, a manufacturer self-certified QMS is perfectly fine. Otherwise, a Notified Body certification is needed. Make sure you adopt the correct QMS certification route for your device.
4. Good Development Practice
“Begin with the end in mind” as Steven Covey said. As you develop your device, picture how the documentation will come together for the submitted device.
The Design History File and Risk Management activities will tell the story of development, demonstrating why and how you arrived at the eventual solution.
The Technical File will provide the complete dossier of information that describes the medical device manufacture, assembly, testing and release requirements.
Robust, applied Documentation Control and Change Control ensure that you minimise the opportunity for surprises popping up at the end of development. Start Change Control at an early stage in development, so design decisions are captured and can be referred to easily when answering regulatory authority questions on the submission.
Traceability Matrices should be your (new) best friend – they’re invaluable in ensuring that you’ve covered all the bases during planning, designing, testing and reporting. If they’re created as you go along, headaches will be smaller than if gaps are spotted when the matrix is created at the end of development. You may even consider a matrix for the Essential Requirements, to ensure you have documented evidence of compliance with each one.
5. Use Harmonised Standards
Check the most recent update to the European Commission’s list of Harmonised Standards, to see which are relevant for your medical device. Manufacturers or conformity assessment bodies can use them to demonstrate that products, services or processes comply with relevant EU legislation. So following the content of a Harmonised Standard is usually the straightforward route to demonstrating compliance.
6. Take care constructing your Technical File
Make it easy for the reviewer to navigate your Technical File, from a high level overview through to the detailed content that they’ll want to read through. Adopt a logical layout to presentation of information. There’s a handy template for the content of your Technical File provided by IMDRF (for a medical device, and for an in vitro diagnostic device). The IMDRF documents are a few years old now, however the MDR contains a detailed description of Technical File content in Annex 2.
7. Your Clinical Evaluation Report
It won’t have escaped your notice that the MDR includes explicit requirements for Clinical Evaluation and its reporting. There are two major benefits to getting underway with your Clinical Evaluation early in development:
1. The results of your research feed directly into the definition of Design Inputs (what the device needs to be able to do for the user / patient),
2. You have a clear picture of any Clinical testing that is required for the device, permitting realistic budgeting and planning of the project.
8. Post-market Surveillance Plan
Ensure that your QMS incorporates a good system for Post-Market Surveillance (PMS), covering vigilance activities, steps taken for pro-active PMS as well as reactive PMS (i.e. when you’re alerted of a problem, perhaps via a complaint), post-market clinical follow-up. Naturally, all this is supported by a plan for PMS, that pulls all these threads together and demonstrates how information will be used to instigate or confirm design changes, how PMS information feeds into CAPA, Change Control and Complaint Handling processes.
9. Managing Devices in the field
Remember to include activities to provide for CE Marking of your medical device prior to placing it on the market (for Class I non-measuring, non-sterile, this can be self-managed, for all other Classes, a Notified Body must be involved).
Consider what requirements you have for any servicing, maintenance and performance verification while the device is in service, and across its in-use life. These will need to be documented and tested to verify their effectiveness in ensuring continued device performance and safety.
Getting it right, first time
There can be a lot to take in, working through these 9 steps. Rest assured, help is at hand, should you wish for some guidance or support along the way. Get in touch today, so we can explore how best to ensure you reach your goal of regulatory compliance, right first time.