Are you ready for May 26, 2020?
If you are in the medical device industry and sell product in the European Union (EU) you are familiar with the date of May 26, 2020. It’s the day that manufacturers must comply with the EU’s Medical Device Regulation, more affectionately known as the MDR. This is a big project and not one that will happen over the course of a week or month, so you need to be prepared for a long ride. To help you embrace the new rules, O’Connell & Myers has developed a very high level assessment of a few key factors of the MDR.
To begin the process, you should have a conversation with your Notified Body (NB) to make sure they will be able to review your devices. All NB’s will have to be re-certified and you need to make sure that yours will still be qualified to review your type of device(s).
Manufacturers should look at their complete product portfolio and prioritize the products that will carry the brand forward and give the best ROI. The changes required by the MDR may be costly and time consuming. It may not be feasible to have every device compliant with the MDR at first. The MDR will focus on the entire product life cycle such as design, risk/benefit, safety and performance, clinical evaluation and post market surveillance and vigilance so the impact to your product line may be extensive.
Let’s talk about Pre-Market Impact. To start companies will need to identify a person that is responsible for the regulatory process. This may not be that big of a deal since 21 CFR 820.20 requires a Management Representative and that person may already be in place. So so far so good, right??? But wait there’s more.
Some devices may change classes, and this will have big impact on what happens next. So, it’s a good idea to take the time to understand what class your entire portfolio will be per the MDR before you develop your action plan. You don’t want to go far down the road and realize that you took a wrong turn at Albuquerque.
The Essential Requirements Checklist is going away and replaced by the Safety and Performance Requirements, so you will have to update your SOPs and requirements template. This document will require that you include the method of conformity of how you meet the requirements. This means that you need to provide justification such as animal or clinical testing, validation/verification data in the document and cross reference them specifically instead of just pointing to the procedure.
The technical documentation format will change so you will have to update your tech file template to meet the requirements of Annexes II &III. Your Declaration of Conformity format will also need to be updated per Annex IV.
The MDR is aligned with ISO 13485:2016 meaning that there will be more emphasis on risk/benefit and statistical processes and how they impact safety and performance. This means that you will most likely have to update many of your SOP’s and work instructions to account for the 2016 version of 13485.All of your SOPs will also need to incorporate risk into them.
Every device label will need to be updated. The MDR requires that all device labels have a UDI as well as a medical device symbol (yet to be determined). The UDI information must be published in the EUDAMED database. The MDR has a great deal of emphasis on transparency and traceability so the UDI must be on the implant cards for Class III devices, in the technical documentation and on the Declaration of Conformity.
Device companies will have to show control over the Economic Operators (i.e. manufacturers, distributors, importers and authorized reps in Europe). You may want to include your legal team in this discussion because you will most likely have to revise all the current agreements you have with these third parties. In addition, authorized reps must have a copy of the current technical documentation available. How you define “available” is currently left up to you to decide. It could be hard copy, soft copy or cloud copy.
Ok, so lets talk a little about Post Market Surveillance. The MDR requires a very robust PMS system. Many of the MEDDEV guidances have been incorporated into the MDR such as clinical evaluation reports (CER), post market clinical follow up (PMCF) and post market vigilance so you may see some familiar processes. PMS activity must be reported into the EUDAMED database. This is done by uploading Periodic Safety Update Reports (PSUR) and Summary of Safety and Performance reports. The frequency of reporting depends on the risk class of your device. The MDR also wants your to not only keep track of your device trends but to also be aware of the similar devices and their issues so you can be proactive in your safety and risk evaluation.
As you are aware with all the reporting requirements you need to have good statistical methods for data trending and SOPs that define when to take action. These trends should feed back into your CAPA, risk and CER evaluation.
With all these changes coming you can imagine the impact on your document control system and how many SOP’s and work instructions that will need to be created or updated.
So here are a few take-aways
Communicate with your NB ASAP and get on their inspection schedule.
Make sure you have enough budgeted.
Determine what class your products will be.
Evaluate your CERs and product testing.
Develop a solid plan.
Make sure you have enough resources.
Update your QMS so it can handle ISO 13485:2016 and the MDR
Start the updates to the technical documentation.
Schedule any new testing or re-testing ASAP.
Inform your organization about the changes and what to expect.
As you can see this is a HUGE project. Let O’Connell & Myers help ensure that you will comply with the MDR to meet the May 26, 2020 deadline.