Here’s ten things you really need to know about the new European Medical Device Regulation.
1. Transition periods
You have three years to make the transition if you’re working in medical devices. Well, actually, a bit less – the transition period began on May 25th 2017. If you work in in vitro diagnostic devices, it’s five years.
2. Early adoption
Paul Brooks from the Regulatory Affairs Professionals Society (RAPS) says that early adopters will retain a competitive advantage, as the market may be sensitive to new products which don’t comply.
3. Re-classification
Some devices will end up being reclassified under the new regulations. This could put them into a higher risk category.
4. Technical documentation
As a result of some potential re-classification, the BSI says that Notified Bodies will be scrutinising technical documentation more closely. Manufacturers with devices likely to be impacted by re-classification will need to be prepared for this.
5. It’s an opportunity
Brooks argues that manufacturers can use the introduction of the MDR as an opportunity to remove poor performers from the market. Before doing so, he says, they must consider whether they have more modern versions or better performing products that can comply.
6. The language will be crucial
Quality specialist firm InfinityQS issued a statement arguing that “the real challenge for an industry as large as this one, across member states and the UK, is developing a universal language that can be used for internal traceability right along the supply chain. This encompasses everything from vendors, right through to the hospitals where the end product is used.”
7. It could impact customers
Brooks admits that failure to comply could ultimately result in healthcare systems and patients being unable to access some devices. Obviously, if suitable alternatives are not sourced, this will impact patients. Brooks says this is the worst-case scenario.
8. The definitions are shifting
What is a medical device, and what isn’t? Well, according to the MHRA, EU MDR means that some products, including dermal fillers, non-corrective contact lenses and brain stimulation devices will now be regulated in the same way as medical devices.
9. There could be post-market changes, too
The MHRA says that the new regulation offers clearer requirements on what a manufacturer’s post-market surveillance system should comprise of.
10. Help is out there
The BSI has put together a useful presentation which answers many of the questions manufacturers may have – it’s available on the website, bsigroup.com.
