Medical Device Regulations – Links You Should Be Aware Of
Medical Device Regulations – Links You Should Be Aware Of
Overview
These are the most important regulations to be aware of governing Medical Devices in the European Union.
If you want to sell your product for the first time in the EU member states, a familiarity with these regulations must be established.
MDR – EC Regulation 2017/745
These are the full texts of the governing regulation 2017/745. There are two relevant documents, one for Medical Devices, and a second for Invitro diagnostic processes.
Regulation (EU) 2017/745 – For Medical Devices
Regulation (EU) 2017/746 – For In vitro diagnostics processes
Meddev 2.7.1 Rev 4
The Meddev Regulation is a set of guidlines for conducting an effective Clinical Evaluation Report (CER) and the containing Literature Review.
If you are going to have in-staff writers work on your CERs, it’s vitally important that they are aware of this document and submit their reviews accordingly. Submissions not following Meddev will likely be significantly delayed by the Notified Body or outright rejected. You can read the full document here.
https://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/en/renditions/native
The CER and Literature Searches are what we specialize in at CiteMed. Our proprietary system guarantees perfect formatting of the final report and Meddev 2.7.1 Rev4 compliance. You can see one of our sample reports today by filling out one of the contact forms.
ISO 13485 – Quality Management System
This is not a direct checklist style requirement. BUt more of a set of guidelines that a device company must implement in some way to regulate the production of their products.
It is referenced specifically in the CE Marking Certification Process ( MDR ) and thus should be mentioned here. You will need to show some effort of complying/documenting your manufacturing process in accordance with ISO 13485 when you begin the CE Certification process.
The paper can be found here
