Ensure compliance with the EU MDR using this essential requirements checklist for MDR. This document summarizes the detailed procedures businesses must follow in compliance with the EU 2017/745 regulation.
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An EU MDR checklist is a list of requirements for compliance with the European Union Medical Device Regulation 2017/745. The European Parliament and the Council of the European Union released these requirements in 2017. The EU MDR regulations aim to ensure a high standard of safety and quality for medical devices produced in or supplied to European Union member countries.
The EU MDR replaced the European Union Medical Device Directive (MDD), which had been in place for about 25 years. The MDD included the framework for medical devices but did not contain regulations for in vitro diagnostic medical devices.
Some of the reasons why the existing regulations needed updating:
These are some of the factors that lead to the improvement and replacement of MDD. The EU 2017/745 regulation provides and ensures compliance with strict standards for medical devices throughout Europe.
The essential requirements checklist for MDR must cover all 175 pages of the EU MDR. It consists of ten chapters, 123 articles, and 17 Annexes. As organizations dealing with medical devices, businesses must commit to helping EU member states improve the safety and performance of medical devices in the region. Using an EU MDR gap assessment checklist ensures the protection of patients and medical device users.
An EU MDR checklist helps you determine how prepared your company is for compliance with the EU MDR. It shows that you have a thorough understanding of the MDR, how far along your product is in its observance of the requirements, and what you still need to do to meet the requirements for getting access to the EU market.
Prepare a comprehensive EU MDR compliance checklist when planning to assess your product against the new regulation. It should answer questions such as:
The following are some of the new EU MDR Requirements:
Preparation is vital when ensuring compliance with EU MDR. Here are five things you can do now to make sure your product meets the new regulatory requirements:
Know where your products currently stand. Plan how you will assess your devices against the new MDR guidelines. Assessment could mean reconsidering your device's classification. An MDR audit checklist can be a great help in this area.
Understanding the differences between MDD and MDR is vital. Review Annex I, General Safety and Performance Requirements (GSPR), to find out what conditions you must address for your device. There will likely be a need to update clinical data, technical documentation, and labeling of products. Prepare an MDR GSPR checklist to ensure you cover everything from quality assurance to risk management and postmarket study.
Identify deficiencies and ensure your products meet the general safety and performance requirements. Many MDR requirements are similar to MDD requirements. Still, the new regulation includes more prescriptive emphasis on reviews by Notified Bodies to confirm compliance of devices.
Use an EU MDR gap assessment checklist for conducting a thorough gap analysis that evaluates how criteria changes affect your products. The analysis will determine the areas requiring more time and effort.
Conducting a gap assessment and acquiring a complete understanding of MDR is time-consuming. But these activities are necessary to ensure you have continued access to the EU market.
The gap assessment must include general safety and performance data, risk assessment, clinical evidence, technical documentation, labeling, data entry to the EU database, and postmarket research. You must also consider traceability, quality management, and maintenance of technical documentation.
Once you have performed the tasks in your EU MDR gap assessment checklist, address the identified gaps immediately. You might need to hire new staff, allocate additional time, and adjust your budget to handle the work involved.
The transition from MDD to MDR could seem overwhelming. Start small and take on one requirement at a time, especially if you have multiple devices in your product portfolio.
Pick one or two products for a pilot process. Compile data and documents for two products to help you understand what is acceptable under the new regulation. You will be able to perform the process more efficiently and effectively with the rest of your products once you have a complete understanding of the requirements.
Reclassification will likely affect only 10% of medical devices. But you must be familiar with the classification changes to determine whether they will affect your products. If your products need reclassification, additional gaps are needed, which requires more resources. Conduct conformity assessment, especially if manufacturing automated external defibrillators, active therapeutic devices, and orthopedic products.
The EU MDR also includes new rules for classifying software and devices using nanotechnology. Ensure you understand the new classification rules if you are involved with these products.
With a digital EU MDR checklist, you can ensure compliance with EU MDR requirements using the audit app on your mobile phone or tablet. The checklist is available online and offline, so you can use it whenever needed.
Use Lumiform's software to create custom checklists, evaluate data, and plan how to solve the identified gaps. Keep your employees updated about their assigned tasks for timely completion and give them the best, most complete information possible by including pictures for reference. Keep your audit data in one place and make your reports valuable and easy to understand with charts, tables, and audit histories.
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