What Is EU IDVR
EU IDVR is a new regulation that has been updated in the European Union to help monitor the creation and use of medical devices. IVDR stands for in vitro diagnostic medical device. This new regulation will replace the EU’s old regulation. So any medical device companies who are using the old IVDR standards should change within the given time frame depending on their own unique circumstances. EU IDVR compliance is mandatory and if the change is not implemented then there could be severe consequences for any company who does not comply. There has been a timeline implemented for manufacturers to meet the needed requirements of EU IVDR. For medical devices that have already gotten approval these manufacturers have exactly until the 26th of May 2022 to get themselves in EU IDVR compliance.
The Initial Step To Getting In EU MDR Compliance
With 2020 vastly approaching medical device manufacturers now only have two short years remaining to get themselves into EU MDR or IDVR compliance. For companies who are producing or marketing any type of medical devices they should have a sense of urgency when it comes to getting their company up to par with the new regulations in the EU. The first and smartest step would be to hire a consultant that is a compliance expert who understands the new EU regulations inside and out. This expert can assist your company in making a comprehensive gap assessment because they are experienced and know exactly what it takes to get your company in compliance with the EU MDR. Other things that will be needed by companies to ensure a smooth transition is a global impact assessments and portfolio revision. The new EU MDR is also not allowing any legacy products to be grandfathered in. These new guidelines are strict and the EU plans on following every aspect of the new regulations.
After all the initial matters of the transition is taking care of such as developing a plan. The next step will be to implement the plan and get all of the staff trained up on all the changes that have occurred with the EU MDR. There are three specific things that you want your project team to be aware of. The whereas section in article one needs to be read thoroughly. The team should also study and be aware of the instructions for Notified Bodies which is 35 pages. The team should also know how to meet all of the requirements for clinical data and quality.
Why The Changes To The EU MDR
There are a few different reasons for these EU MDR changes. The EU wants to make improvements when it comes to boosting the supply chain and to help Notified Bodies in any way that they can. The changes also puts the pressure on manufacturers to provide more proven data that insurers any device that they are putting on the market is safe and performs well. The old EU MDR standards were clearly out …Read more