The full implementation of the EU MDR (Medical Device Regulation) was recently postponed until 26-May 2021 and for any Medical Device company that wants to sell their products in the European Marketplace, they have to be compliant with MDR.
So, now you have plenty of time to get fully compliant with MDR? Not really, I’m afraid. There is plenty to do in the coming year as the shift from MDD to MDR is quite significant.
But where do I start? Pharma IT have put together a list of relevant questions and can help you find the answers too – here are a few questions that will tell you if you should dig deeper to ensure you can sell and distribute your product after MDR:
- MDR introduces a new MD classification of products. Several devices not covered by the previous Medical Device Directive (MDD) requirements now fall under the MDR requirements, and many cases, the devices need to be re-classified. Have you completed the Technical Documentation of your product? For Class I devices, the MDR Annex II + III will be a good starting point.
- For Class I, sterile devices, it’s required that you have an ISO-13485 certified Quality Management System (QMS). You can read more about that in Annex IX of the MDR. Do you already have a QMS and remember, that the certification also has an expiration date?
- Are you sure that your company procedures and politics are ready for MDR and eventually a 3rd party inspection? Here you can read more in Article 83, Annex XIV and XV.
- Once you go live with your product on the EU Marketplace, it is required that you are ready to fulfil your Post-Market activities. Do you have a surveillance system and a system for reporting incidents and safety corrective actions ready?
- Do you have a robust Risk Management process in place, to ensure the desired high level of health and safety for the patients? – If not, try taking a look a the FMEA method to ensure identification of defects.
So, it’s not easy to know if you are fully ready for MDR in 2021 – but for the start-up or smaller MD manufacturer, a good beginning is to reach out to the Pharma IT Medical Devices Team – we are here to help you move towards compliance.
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