What is MDD and MDR
From the MDD to the MDR - this is how you make the transition
In order to be able to sell medical devices within the European Union (EU), medical device manufacturers need a valid MDD certificate. Under the new European Medical Device Regulation (EU-MDR 2017/745), which came into force in May 2017 and which from May 26, 2020 must be complied with, manufacturers are assessed according to new regulations and therefore need new MDD or MDR certificates for their medical devices and products.
Existing MDD certificates will be valid until May 2024. Companies that want to continue selling their medical devices in the EU after this must switch to the EU MDR before this date. To do this, they need both their Technical Documentation as well as the documentation within your Quality Management System (QMS) adapt sustainably.
However, many manufacturers are not aware of how long the transition to the new MDR regulations will actually take. If you do not start planning early enough, you may not have a valid MDD or MDR certificate for a longer period of time and you can no longer sell your products within the EU, as these may be withdrawn from the market. In fact, experts believe that up to 30% of all medical devices could disappear from the market due to the EU MDR.
MDD Versus MDR Checklist: What Should You Do to Prepare?
1. Plan your first MDR audit
After the first MDR audit and the evaluation of your product documentation, it will take at least another 12 monthsuntil a new MDR certificate can be issued. For this reason, the first MDR audit must be scheduled at least one year before the expiry date of your MDD certificate. An audit can only be carried out if the adapted documents from your notified body at least 6 months before the first MDR audit be available. Take care of sufficient time and resourcesto change your technical documentation.
2. Check the validity date of your current MDD certificate
Your transition to the MDR certificate is imperative before this specified validity date to be finished. This not only includes an audit and certification of your QMS; yours too Product documentation must comply with the new MDR requirements be rated. The clarification of related issues or the handling of non-conformities can lead to further Delays to lead. You should therefore plan enough time for such activities.
3. Prepare for the transition
You will need a new MDR certificate at the latest when your MDD certificate becomes invalid. So you need to be timely with your Preparations, Gap analysis and also with the Resource planning start. Getting this done will presumably at least two years last. Therefore, the more time you plan, the better.
Your next steps
Would you like to learn more about the preparation of your technical documentation within the framework of the new EU MDR requirements? Arrange a free, non-binding demo with us and start digitizing your clinical validation processes and proactive market surveillance measures!
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Further EU MDR content for download
Infographic: Overview of the post-market monitoring process
Whitepaper: Mastering PMS in the EU MDR Era
Playbook: How the EU-MDR will shape the future of the medtech industry
Infographic: Conduct clinical trials and PMS paperless
Dragan | Co-Founder & CTO
Digital Health Entrepreneur. Enthusiastic about clean UX and traveling to exotic countries. Product development with passion.
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