Preparing your medical device for EU MDR can be a complex process. Work with trusted MDR consultants on Kolabtree to get help with writing a clinical evaluation report and make sure your device is MDR-compliant.
The European Union’s Medical Device Regulations (EU MDR) is a new set of rules and regulations that will replace the current Medical Device Directive (MDD). Every medical device company that wants to place a device in the EU market has to comply with the MDR, which will come into effect on 26 May 2020. Getting your product ready for EU MDR can be a complex process that involves compiling complex technical documentation and getting your products re-certified.
All medical device manufacturers need to get a “CE Mark” to show that their product meets the requirements of the MDD/MDR. The CE mark is legally required by any business to sell a medical device in the EU. To apply for a CE mark, the medical device company has to submit an application to their Notified Body, a set of regulatory bodies designated by the Government to assess the conformity of certain products.
To get the CE mark, you must first determine which of the MDR rules apply to your product. Then, conduct a thorough evaluation of your product to ensure that it meets each of the directives and complies with regulatory standards. Once you verify that the directives are met, put together all the technical documentation required for your product in a “Technical File”. This provides a comprehensive view of your product along with instruction manuals, quality control procedures, and a Clinical Evaluation Report (CER).
A CER review is one of the most important documents you will need to satisfy the MDR requirements. The CER contains the conclusions of the clinical evaluations performed on your medical device, which are done regularly throughout the life cycle of the product. It involves gathering data from existing literature, clinical trials, demonstrating evidence of safety and efficacy, and more. Working with an expert CER writer can help you save time, effort and increase your chances of getting approved quicker.
Even though the deadline is quite close, there is still confusion and lack of clarity about what how to go about achieving MDR compliance. Here are 8 trusted resources to help you understand the basics of the EU MDR so that you can plan out your next steps.
- The European Commission’s guide to the new regulations:
- The EU’s guide to CE marking
- An introductory guide to the MDR and IVDR, prepared by the MHRA
- Read the BSI’s whitepapers, which provide an overview of what’s changed in the MDR and how to prepare for it
- Guidelines from the European Medicines Agency based on medical device categories
- Greenlight Guru’s quick guide: “7 Questions about the MDR answered”
- Professor Christian Johner’s video explaining 5 main changes that the MDR introduces
- Transitioning from the Medical Device Directives (MDD) to the Medical Device Regulation (MDR): A free webinar
Small and medium sized medical device businesses worldwide are working hard to get their technical documentation up to date, which is the most time-consuming part of the process. Given the short time frame and the high level of expertise required for the job, many of them are struggling to meet the requirements. Most of these businesses simply cannot afford to have their application rejected or be asked to rework it. Hiring a freelance medical writer or a Clinical Evaluation Report writer can help companies easily put together everything they need to comply with the EU MDR and accelerate the time to get their products certified within the looming deadline.