The European medical device regulations (MDR) provide a minimum standard in Europe for health equipment manufacturing or exporting.
We know it is hard enough to remember the new changes and guidelines when it comes to MDRs.
Keeping up with the latest regulations can be overwhelming and time-consuming. Therefore, we created this free EU MDR readiness checklist for you!
The new EU MDR Regulations
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.
The MDR has been in effect since May 2017 but will not be fully enforced until May 2021. However, there is no “grandfathering” of products placed on the market under the current regime; manufacturers will have to demonstrate compliance with all of the new requirements for products to remain available for sale in Europe after May 2021, or at least will have to start the process.
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!
How to prioritize your actions for EU MDR readiness?
The Checklist tool generally helps us to effectively plan our workload. But the new Medical Device Regulation (2017/745) is a mass of new requirements. The checklist can become a nightmare or much too superficial of a tool.
This article offers a hands-on approach based on practical consulting experiences. The ultimate goal is to be regulatory compliant and at the same time, to maintain or gain competitive advantages in the moving MedTech industry.
What you need to do to follow the MDR readiness checklist
Tip 1: Take a Breath:
Tip 2: Simplify your QMS to speed up your remediation projects.
Tip 3: Be aligned with the current medical product standard and increase your internal testing capabilities. Identify the correct classification rules for each product and if applicable, the product’s risk class.
Tip 4: Use operational checklists for each Audit.
Tip 5: Build your MDR Action Plan with our proven check-list (included Free)
Tip 6: Do not wait until the last minute, but start planning your compliance process now! Active implantable medical devices have a longer transition period, while for all other medical devices this is very little considering everything you need to do.
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.