The Medical Device Regulation (MDR) has been a regulatory framework since 2017. The MDR is designed to ensure that medical devices are safe, effective, and high-quality.
While the EU had given time for the manufacturers to adjust to the new regulations, the deadline for that has since passed. The EU now requires manufacturers, agents, and distributors to comply with the MDR for each medical device launched in the EU market. So, as of now, if you’re manufacturing a medical device, you need to be familiar with the Medical Device Regulation (MDR) and ensure MDR compliance.
Nevertheless, medical device regulations are still confusing and complicated. The lengthy document has numerous articles, chapters, and annexes bound to confuse anyone. Additionally, due to the complex nature of the document, some small slips tend to happen, and companies often have to redo the entire process a few times to get it right. Even so, if a few documents get mixed up, it’s not that much of a bother. On the other hand, missing a vital albeit small detail, like the lack of informed consent, can lead to redoing an entire part of the MDR process, driving up the cost and significantly delaying the launch.
Suffice to say, getting MDR compliance for any device is a headache for everyone involved. But, it doesn’t have to be. Like any other complicated task, the key is to divide and conquer. Here we have assembled an MDR checklist covering all aspects of regulatory compliance — from the basics of an MDR submission to the different types of submissions and what they entail. It outlines the precise procedures required for organizations to comply with the standards. We’ve also included tips on ensuring your submission goes smoothly (and fast).
A single responsible person
Start by assigning one person or department responsible for MDR compliance. This person will ensure that you’re staying on top of the regulations and ensuring your products are safe. That is not to say they will do all the work. They will be in charge of following the other team’s work and compiling all the documents. Having this as the first step is crucial because it will ensure that the company’s MDR compliance efforts are not scattered but instead have a single point of contact who can help ensure the necessary processes are in place. The person holding this position is often called EU PRRC.
Gather all the documentation for your product and your QMS. You’ll need to know what’s included in your ISO 13485 standard and how it compares to your company’s existing procedures. It may take some time to gather everything together, but this step is crucial because it saves you time and effort down the road.
ISO quality management system
Confirm that the coverage of your ISO quality management system is sufficient. This can be done by comparing your existing quality system with the standard’s requirements. If there are areas where more work needs to be done, then those are the places where you’ll want to focus on improving before beginning an audit.
Gap analysis between the MDD and MDR
if your device isn’t entirely new, you will need to collect data from the MDD documents you have before upgrading to MDR. This is to determine what data is missing and find a way to collect it. In order to do it effectively, you must clearly identify which parts of your product are most in need of improvement. Finally, you’ll have to ensure that all of your documentation is up-to-date so that it matches with what’s in your MDR.
Notified Bodies are independent third-party organizations that are accredited by the EU to assess a product, process, or system to ensure that it meets all relevant regulatory requirements; knowing them and their views on your project is pretty important. They will be responsible for ensuring that your device is abiding by the EU MDR’s framework. So, early in your MDR process, having information regarding them will come in pretty handy.
The MDR is more specific and updated than the MDD, so you can expect that many of your existing devices, which were certified before, need recertification.
The MDR classifies medical devices into four categories: I, IIa, IIb, and III. Determine in what class your device falls according to the MDR device classification and create a checklist of the criteria it needs to fulfill accordingly. This prepares you to take particular notice in risk management for high-risk devices (IIb and III).
Unique Device Identification
Don’t forget the Unique Device Identification: The EU Medical Device Regulation (EU MDR) requires that any medical device must have a unique identifier. This is necessary to track devices and prevent patients from receiving multiple devices with the same identifier.
- Ensure to take all steps required for the ideal CER and Literature Review. Hire experts if needed or train your staff extensively.
Safety and performance
- Have a general risk management plan and, along with it, keep several risk control measures in place. Include an assessment of risk in your final checklist. Make a checklist of all data and associated parameters required for clinical efficacy and safety evaluation.
- Determine whether all products can be supported through formal modification procedures as needed or if a new design dossier is required. This will depend on how the product has been modified from its original design.
- If you have been conducting clinical trials for the same product for a long time, you may already have a significant amount of information about the safety and effectiveness of your product. First, determine whether any clinical evaluations are required and which existing clinical data ysou can leverage from pre-MDR submissions and other sources.
- List all product properties, including their function and physical and biological properties. Also, list all substances of concern that are used in the products. Match them with MDR.
- Update or design a post-marketing vigilance process and plan corrective actions.
- Apart from your team, you must also ensure that compliance is maintained throughout the entire supply chain, from the manufacturer to the distributor.
- Have a list of all the final documents you need to submit and check for.
List of Documents
- EU Declaration of conformity (DoC)
- List of UDI-DI
- Safety and performance summary
- Risk management plan, files, and reports
- Clinical evaluation plans and report (CEP & CER)
- Consent and application details
- Clinical investigation plan
- Clinical investigation report
- Investigator details
- Safety and performance report
- Post-market surveillance plan (PMSP), clinical follow-up plan (PMCFP), and report(PMCFR)
- Periodic safety update report (PSUR)
- Field safety corrective actions
- Adverse Effects
Technical File Documentation
- Device description, specification, labels, user instructions, and design info
- Process of manufacture
- Pre/clinical testing reports