There’s been a lot of focus on the process for re-designation of Notified Bodies in Europe – so that we can all start the process of certification to the new Medical Device and IVD regulations. But what happens if your Notified Body fails to achieve re-designation, or has its scope narrowed – or just gives up and goes away?
The new MDR is a long document, with interminable preambles and no quick way to get to the key Annexes.
So to help we have extracted the two key Annexes on Classification and Safety and Performance Requirements (Replacement for the Essential Requirements) into tow handy PDF documents.
The European Medical Device and Active Implantable Medical Device Directives have for more than 20 years provided the “best practice” regulatory model which has been adapted into so many other markets around the world. But now Europe has changed. How will other markets deal with the regulatory disconnect between the new European Model and the now outdated copies around the world? Is this new global disharmony a threat – or can others follow Europe’s lead and take the opportunity to deliver a more harmonised global regulation?
Although the Europeans have retained risk classifications and 3rd party conformity assessment based on risk class, the new MDR changes almost everything. In more than ten times as many words as the MDD and AIMD, the new regulations provide much more detailed requirements and set a higher bar especially in clinical evidence, postmarket monitoring and risk management, integrating all of these into a single living process. The race is on for the three year transition period – it’s going to get busy…
As the political process to finalize and implement the European Medical Devices Regulations, it’s worth taking a look at what actually happened. Remember, this reform was triggered by international concerns about safety of higher risk implantables, in the wake of the PIP breast implant scandal, as well as some high profile post market failures of other implants including metal on metal hip joints. The response has certainly been to strengthen Europe’s regulation of devices. But a closer look shows that this reform is more about governance and rigour than fundamental changes in approaches.
What does UK’s decision to exit the European Union mean for the UK market and for the CE marking of medical devices and IVDs. We take a look at the issue from the perspectives of manufacturers, Notified bodies and the MHRA and ask – should MHRA take a leaf out of the Australian TGA’s book?