Our commitment to EU MDR
The EU is placing greater emphasis on safety measures, risk management, post-market surveillance (PMS), and data collection for medical devices. Subsequently, MDR holds more rigorous demands on medical device manufacturers and the notified bodies designated to assess the conformity of the manufacturers.
Due to significant changes within MDR, medical device companies may be required to re-design certain core processes to meet the new regulations. NuVasive has proactively assembled our Clinical Affairs, Regulatory, Quality, Supply Chain and Commercial teams to navigate the robust MDR priorities and timelines. The extensive and collective efforts demonstrate our focus to comply with MDR, while supporting our mission to transform surgery, advance care, change lives.
If you have questions about MDR implementation at NuVasive, please contact your local sales agent.
Regulatory overview
The EU MDR, which replaces the Medical Devices Directive (MDD) (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), was introduced in May 2017. The original Date of Application (DoA) of the new regulation was scheduled for 26 May 2020. However, due to the COVID-19 global pandemic and the associated public health crisis, the European Parliament postponed the DoA of MDR and extended the validity of the MDD by one year. Therefore, the MDR DoA is 26 May 2021.
CE certificates issued under the MDD, before 26 May 2021, may remain valid for up to four additional years (26 May 2024).
Starting 26 May 2021, the DoA for MDR, all devices newly entering the market will need to hold a CE certificate under MDR. Thus, legacy MDD and new MDR devices may be available concurrently during this transition.
All devices entering the market from 26 May 2024 must fully comply with the MDR. Medical devices already placed on the EU market under the MDD before 26 May 2024 can be put into service until 26 May 2025.
NuVasive obtains CE mark for all class IIa, IIb and, and III products from the notified body. A “notified body” is a private company that is “designated” on behalf of the European Union to check the conformity of a manufacturer with the MDD/MDR. BSI is the notified body for NuVasive and DQS is the notified body for NuVasive Specialized Orthopedics, Inc (NSO).
Key changes from MDD
The classification rules have been expanded to include Ir class (reusable surgical-invasive instruments). The requirements for implantable class IIb products have increased. New risk classes have been introduced for some product categories, which means certain products may be classified higher.
Clinical investigations will be required when sufficient clinical data to support safety and performance claims is not available. Regardless of class, all medical devices will be subject to clinical evaluation.
Manufacturers will need to re-prepare their clinical evaluation by considering the new wording of the regulation on when to use equivalence approach and under which circumstances it is possible to justify not conducting a clinical investigation.
The definition of medical devices and active implantable medical devices has been significantly expanded to include devices that do not have a medical intended purpose.
align with the Global Harmonization Task Force (GHTF) recommendations. Minimum requirements and structure for technical documentation is defined in the MDR, and a rationale must be provided for any exceptions.
for enhanced traceability and transparency. Over time, a UDI will need to be placed on the label and/or package of medical devices. UDIs empower the patient to do their own research on the safety and efficacy of the device.
Under MDR, patients who receive certain implants will be given an implant card by the healthcare provider (supplied by the manufacturer at the time of surgery), informing them about the device, its UDI and manufacturer.
an electronic database for monitoring the product life cycle. Certain device information will be available in EUDAMED, allowing patients to make more informed healthcare decisions.
designated employee(s) with regulatory expertise appointed by medical device manufacturers to ensure compliance with the EU MDR.
including more frequent documentation review and increased technical oversight to ensure device safety.
Increased requirements for the Notified Bodies including obligation to carry out unannounced audits at manufacturers.
How NuVasive is preparing for MDR
NuVasive recently renewed the MDD certificate for class IIa, IIb, and III devices. The NSO certificate is planned to be renewed under the MDD as well. All applicable NuVasive devices are currently CE marked under the MDD and will be offered on the EU market under the MDD certificate until 25 May 2024.
NuVasive’s notified body, BSI, is already designated under the MDR. NuVasive has applied for the MDR certification with BSI and will submit its first device application for CE mark under the MDR this year. NSO’s notified body, DQS, is awaiting MDR designation.
Until 26 May 2021, certain line extensions and design changes of existing systems can be introduced under the MDD. However, new product lines, changes to indications for use for current systems, and significant changes to existing product lines will need to be reviewed under the MDR.
Until May 2025, products certified under the MDD and under the MDR will coexist in the marketplace. While there is no need to differentiate them to our customers, certain requirements of the MDR, including post-market surveillance, registration and vigilance requirements, are applicable to current products in our portfolio. NuVasive has updated certain internal processes to comply with these requirements for all applicable systems. Additionally, even though not necessary, NuVasive chose to update product labeling for all current products to provide consistent MDR compliant labeling for our customers.
NuVasive’s product portfolio in the EU has been optimized to balance market demands, promote proper planning and improve inventory efficiency.
NuVasive has been introducing legacy and new implantable devices as a sterile pack option to address business needs of our customers and provide UDI compliant labels. All labels for MDD and MDR devices have been updated to include UDI and other information to comply with MDR requirements.
NuVasive has indicated multiple PMCF studies to continue gathering data related to our CE marked devices as part of post-market surveillance process.
The NuVasive PMS program has been continuously evolving to comply with enhanced post-market surveillance/vigilance regulations and enable development of best-in-class, innovative, future generation products.