Medical Device: 238 days!

238 days and counting down.  That’s the number of days before EU MDR goes into effect.   For many Medical Device companies this seems like very few days to get ready!   If you factor in weekends and holidays – it’s only about 170 days.

This raises some key questions to consider:

  • Do you have enough time to prepare your product, documentation and systems for MDR so you can continue business also after 26-May-2021?
  • At the time of this blog (late September 2020) for MDR, in all of EU, there are only 17 Notified Bodies who can assess the conformity of your product before being placed on the market – will they be able to process all applications in good time?

It is very likely that there could be a bottleneck of applications early 2021 and many companies risk a disruption to their business, so our advice is to get started now on your journey towards MDR.

At Pharma IT we get questions and requests for gap analysis on MDR Readiness.   Additionally, a common theme is the need to collect and organize the required MDR documentation in relations to MDR Article 5.5 and what is needed for securing the CE-branding of software and medical devices.

One of the first actions, is to have a validated Quality Management System (QMS).   Pharma IT has a scalable Cloud (SaaS) solution which can be tailored to your needs.   Equally important is the content in the QMS and at Pharma IT, we have the necessary templates ready to go.  You fill in your own product, policies and work instruction details and you are ready with your QMS.

We have consultants ready to help with business and gap analysis, setting up a cloud based QMS and loading it with your product artefacts.

Contact Director Per Andersen if you need to know more: pqan@pharmait.com