The European Union Medical Device Regulation (MDR – 2017/745) will be replacing the existing Medical Device Directive (MDD) in May 2020. Compared to the MDD, the MDR has implemented stricter procedures for conformity assessment, and equivalence will be more rigorously interpreted. Additionally, the new MDR places added responsibilities and obligations on a foreign manufacturer’s legal representative or EAR (European Authorized Representative).
Key changes between the MDR versus MDD:
- Role of Economic Operators & Person Responsible for Regulatory Compliance – Economic operators include manufacturers, distributors, importers, suppliers, subcontractors, assemblers, and EU Authorized Representatives, all of whom carry responsibility for conformity to the medical regulation.
- Vigilance & Post-market Surveillance (EUDAMED Database) – Additional economic operator interaction /involvement with the EU database on Medical Devices (EUDAMED). Mandatory EUDAMED reporting has been postponed until 2022.
- Scope and Classification of Products – Some devices are being reclassified to higher classes. In addition, some devices that were previously exempt from the regulations are now in the scope of the new legislation.
- Changes Affecting Notified Bodies – Supervision of Notified Bodies will change considerably.
- Device Labeling – Unique Device Identification (UDI) will be introduced to provide traceability on all medical devices and will be placed on the label of the device.
- Clinical Evaluation – Reinforced rules on clinical, performance evaluation, and clinical investigations will require a thorough review of clinical strategy and post-market clinical follow-up plans.
- European Authorized Representative Liability – Makes the European Authorized Representative (EAR) selected by a manufacturer, jointly and individually liable along with the importer and the manufacturer for defective devices.
- Reclassification of Software – Under Rule 11, the MDR modifies and defines the classification of medical software.
With the proper knowledge and expertise, G&M Compliance can help expedite time to market by guiding your organization and medical device toward CE compliance. G&M Compliance can provide expertise to assist you with:
- Understanding how the new MDRaffects the design and required documentation for your device.
- Performing gap analysis and transitioning from the MDD to the new MDR
- Determining which collateral standards are applicable to your medical product; collateral standards include IEC 60601-1-2, Collateral Standard: Electromagnetic disturbances – Requirements and tests, IEC 60601-1-11 – Home Healthcare
- Identifying medical device class and family of products
- Labeling of devices
- Assistance in preparation of Technical Files and Design Dossiers to the MDR
- Identifying qualified EAR – European Authorized Representative
- Risk management file review
- Management of often messy Certification Body submittals
If your company is new, with little understanding of medical regulatory compliance, or an established organization that needs to supplement its staff’s knowledge and expertise, G&M Compliance can provide you with what you need to meet your goals.
For additional information or questions, please contact G&M Compliance, Inc. at 714-628-1020