Keeping up with the evolving medical device regulation and compliance landscape can be challenging, particularly when technical specifications from the EU Commission are repeatedly delayed. As members of MedTech Europe and Healthcare Transformation Group, we’re doing our best to keep our customers and partners as up-to-date and informed as possible.
What We Know Today:
The European Union’s “Medical Device Regulation (MDR)” will come into effect on 26 March 2020. The European Databank on Medical Devices (Eudamed), which is essential to the implementation of EU-MDR, will go live on 26 May 2020 with the following modules.
- Actor Registration
- Notified Bodies & Certificate submission
- Device Registration
- UDI data submission
To the best of our knowledge, the following modules will be delayed until the end of 2020, or early 2021:
- Vigilance and Post-Market Surveillance
- Clinical investigations and Performance Studies
As such, these ‘delayed’ modules will trigger an automatic extension of their respective go-live dates by at least six months.
The EU Commission has also announced a ‘transition period’ whereby MDR-compliant devices do not need to be registered for up to eighteen (18) months after the Eudamed go-live date of 26 May 2020 unless there is an adverse or safety incident reported for the device. Upon such an incident though, the respective device must be registered along with all the UDI data and certificates within fifteen (15) days of the reporting date.
It’s important to note that this transition period is neither a grace period nor a deferral. With that in mind, companies/products with low numbers of safety or adverse incidents reported must use a manual method. Companies/products with hundreds or thousands of adverse/safety incidents per year (high volumes of submissions) may approach things differently. Rather than a manual method, a Machine-to-Machine process is needed.
The approved Issuing Agencies have been announced, these being: GS1 AISBL, Health Industry Business Communication Council (HIBCC), ICCBBA, and IFA GmbH. We are still awaiting the official announcement of approved Notified Bodies.
What We Don’t Know Today
Though the Eudamed is go-live dates remain unchanged, we’ve already experienced many months of delays in the availability of critical technical specifications to the EU’s updated medical device database. The technical specifications provided as of May 2019 leave open many questions on important details relating process flows, data flows between Eudamed modules, data definitions, data entity-relationships and machine-to-machine data exchange.
Despite the delay, medical device manufacturers must still prepare to register their products by the second quarter of 2020 or risk the loss of revenue as a result of failing to comply with MDR.
Don’t wait. Start collecting and preparing your regulatory master data using the current MDR data dictionary and Functional/Technical specifications as a guide and keep these best practices in mind:
- Aggregate your internal product master data and submission forms/documents from multiple sources into a single repository for data validation and submission.
- Create a “Global Syndication Hub” that allows your company to scale the processes of Regulatory Compliance around the world beyond Eudamed to include FDA’s GUDID, South Korea, Saudi Arabia and Australia. All these national regulators have officially communicated their intention to implement UDI regulation in the near term.
- Validate and convert the product master data based on the Eudamed-specific attributes, code value lists and validation rules.
- Submit your validated data to Eudamed using a solution partner who is experienced and proven to deliver regulatory submission systems that comply with Annex 11 and GAMP5 standards for system validation.
If you’re ready to tackle these regulations, the Innovit team is here to help you meet the new challenges of Eudamed and the wider MDR submissions.
Innovit is not responsible for any errors or omissions, or for the results obtained from the use of this information. All information in this site is provided “as is”, with no guarantee of completeness, accuracy, timeliness or of the results obtained from the use of this information.