The current EU Medical Device Directives will soon be replaced by new medical device regulations. Whilst the exact date is yet to be confirmed, one thing is clear: requirements and expectations will increase and it is important to begin to understand the effect it will have on your organisation’s wider regulatory landscape.
One of the biggest impacts will be on the In Vitro Diagnostic (IVD) industry. The new IVD Regulation will mean that the majority of self-certified IVDs will require approval or certification from a Notified Body.
What does this mean for manufacturers (and their supply chain)?
- Both new medical devices and devices which are already on the EU market will have to be compliant with the new medical device regulations and, depending on the device concerned, this may require significant extra work
- There will be stronger requirements for pre-clinical and clinical evaluation of medical devices, not only for new higher risk class III and IIb devices but also for lower risk and existing devices that have already been CE Marked
- There will be more mandated unannounced inspections of medical device manufacturers by the regulatory bodies.
What can you do to prepare?
- Look at the clinical data you have. Is it enough? How can you get what you need?
- Expect longer review times for all devices, especially class III devices, class IIb implantable devices and novel devices
- Make sure you are prepared for an unannounced audit – have you established your standard operating procedures (SOPs), and are they up to date?
- Review and update your Technical Files. Will they meet the more rigorous regulatory requirements?
If you are confused or require someone to help, call us on 01482 801801 or click here and enter your details and we will get back to you straight away. Our Medical Regulatory Affairs and Safety Testing experts can ensure you avoid any potentially costly compliance and approval pitfalls by guiding you through the new regulatory process step by step.