MDR: IMPACT after date of application May 26th 2020.

Below is a list of the impact that can affect a manufacture after data of application is gone. Of course this is NOT an exhaustive list. Just a few items that caught my eye.

• If you have a class I reusable or Class III custom made, you currently have no MDD certificate. To continue to sell them in Europe past may 2020, you will need a MDR Certificate prior to that date. If you do not have one, you will need to remove your device from market until you get MDR certification.
• Past date of application has gone, if you have a MDD certificate you CAN’T make a change to the design and intended Purpose of devices listed on the certificate. Does that mean we can't update these MDD certificates or Make any changes to them at all ? Discussion are going on what that means and how much we can do on a MDD certificate- HOWEVER it is clear that any major change, you will need to have to make it under MDR application.
• Not only manufactures are affected by the MDR. Economic operator are also affected. Economic operators need to have a QMS in place. In the past they weren't required too.
• Aesthetic devices, devices without a medical indications such as colored contact lenses, dermo-filler that were not included in the scope of the MDD. They are however covered by the MDR. After May 2020, you will need to have a MDR certificate to be able to sell them in Europe. of course, we are still waiting for the Common Specifications for further understanding of application dates and risk/benefit discussion.
• Single-use devices and their reprocessing ( Art 17): Much more details in the MDR regarding reprocessing of single use, then in the MDD. It is important however to note that "Reprocessing and further use of single-use devices may only take place where permitted by national law". Therefore, it will be important to verify each of the European countries in regards to their law on reprocessing.
• SW products : Include both devices for Diagnostics and Therapeutics purposes- Apps for phone are included in the MDR
• Emphasis on Transparency between users and Competent Authorities across Europe. This is done also via the IMPLANT CARD that will give the patient details about the expected performance or life time of the device.
• LAY PERSON It's the First time that it mentions Lay person not only intended user. The MDD refered to the Intended user. The MDR however, clearly mentions the LAY PERSON (GSPR#22). Referring to the lay person has an impact on the device usability and labelling that were not as present under the MDD.
• Instruction for Use (GSPR#23) - There is a significant increase of information regarding the instruction for use in the MDR. Not only in regards to the UDIs and readability of the labelling. For example Manufactures would not label when a product was not Carcinogenic, mutagenic or toxic for reproduction. As these are clearly mentioned in the MDR, it will be required to follow the relevant Harmonized standards in regards to labelling and using the proper symbols relevant to those risks.
• Transfer from MDD to MDR

The steps can be summarized as following

1. QMS Audit
2. Audit of the Technical Documentation including sterilization process and validation for sterile devices.
3. Receive Certificate

Your QMS certificate will be different from the previous one, obtained under the MDD. It will, most probably have more details regarding exactly what devices fall under the scope of the certification. It will include the product code, product UDI

 QMS will most probably have a limited scope and will increase scope as Technical Documentation for devices are reviewed and accepted. You should discuss with your Notified Body and agree on how the transition will be done for all your devices.