EU MDR Checklist Download – Get Actionable Technical Documentation Requirements
The European Medical Device Regulation (EU MDR) guarantees minimum safety and quality requirements for medical devices being manufactured or imported into Europe. It underwent fundamental revisions in 2017 to improve transparency through standard data, technological advances and the creation of an EU (EUDAMED) database. While the MDD was simply a set of guidelines, MDR is legally enforceable by EU member states. To prepare for the new EU MDR, many medical device manufacturers are in the process of conducting gap evaluations and creating EU MDR transition action plans. With May 2020 around the corner, we understand that a clear understanding of the most critical items to address is crucial and have compiled an EU MDR checklist with actionable technical documentation requirements.
EU MDR Timelines: Common Questions Around the Launch Dates for 2017/745
If you’ve been looking at the upcoming renewal dates for your medical device registration or considering a new product launch, you might be perplexed about the deadlines for introducing MDR and how best to proceed.
What are the Deadlines for Transition to the European MDR?
In May 2017 the new European MDR started a 3-year transition period. The key deadlines for the new EU MDR are:
- May 2020 – completion deadline for the MDR
- May 2022 – EC compliance certificates issued before May 27, 2017, expire
- May 2024 – Available for all EC certificates issued five years from the date of issue/renewal, or four years from the application date of the MDR (May 27, 2020), whichever comes first
- May 2025 – Can no longer sell or distribute devices certified under the MDD
Factors Medical Device Companies Need to Consider for New EU MDR
If you are preparing to improve your device design early, you should consider taking the MDR certification approach. Keep in mind that notified body resources are currently overstretched. With only a handful currently designated, you want to start implementing your device portfolio strategy now, particularly if you have certificates that are due to expire.
A comprehensive quality system and the technical documentation needed for conformity assessment is required.
Impact on MDD-certified Devices Already in the Distribution Chain after May 2020
Medical devices launched on the EU market in compliance with MDD / AIMDD before May 2017 will remain valid until expiration or until May 2024. Note the downsides associated with doing so, if you intend to follow a stockpiling devices approach as a bridge strategy to obtain MDR certification.
- Notified bodies can no longer accept notifications of “substantial” design changes and approve them. This means the device cannot undergo substantial (and perhaps necessary) design changes, including labeling/packaging changes, manufacturing process improvements, or the addition of new features and functionality.
- The devices will need to continue to comply with state-of-the-art criteria, including general specifications and recognised standards provided by the EU.
- New MDR post market surveillance (PMS) requirements need to be implemented along with post market clinical follow-up (PMCF) requirements or justification as to why PMCF is not required.
- Registration for all economic operators must still be completed; furthermore, quality arrangements between the supplier and the Authorized Representative (AR), the importer, and the distributors will need to be in place.
- The MDR will also affect devices not intended for medical purposes, as they are now included in MDR Annex XVI. Products previously deemed questionable or outside the reach of the MDD are now or fall under a new classification as medical devices.
- The new classification rules represent a step towards aligning the classifications of the EU and the US. Under the revised classification rules included in MDR Annex VIII, you need to assess whether any of your devices have moved to a higher classification.
EU MDR Checklist: Overview
Our regulatory experts have worked through the regulations, picking up the most minute compliance points and developing them into a 23-page checklist of actionable technical documentation requirements that you can use to ensure that you are meeting all EU device manufacturing mandates.
This checklist aims to provide a tool for manufacturers to use when assembling the technical documentation as part of CE marking requirements as set out in EU MDR 2017/745.
- General administrative information
- Applicable legislation & Device identification
- General safety & performance requirements (GSPRs)
- Clinical Evaluation (typically MEDDEV 2.7.1)
- Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF)
- Summary of Safety and Clinical Performance (SSCP)
Your company’s regulatory affairs, quality assurance & legal counsel team, will benefit from the checklist. Make sure you are compliant and sign up to receive the checklist today!
Helping You With The New EU MDR Challenges
Celegence has a wealth of knowledge to help you navigate through the complex regulatory challenges that the new EU MDR bring. We can assist you throughout the entire process to ensure that you and your business are compliant with all of the EU MDR requirements.