The notified body shortage is likely to impact medical device companies in different ways. However, it will certainly have an effect on the market as well. Many of the experts on MDR and IVDR believe this will be the main hurdle to compliance. This RAPs article posits that only 27% will be compliant with the new regulations by this May. Some devices may be discontinued or pulled from the market strategically, and some devices will be unavailable due to unintended gaps between certificate expiration and recertification under MDR. Some experts have noted that this has led to a higher volume of initial submissions going through other regulatory bodies (i.e. the FDA) for first approval rather than first submission in Europe. Many companies are finding that it will no longer be easy to get CE-marked first for new products, since bottlenecks are expected with the new notified bodies. This is actually creating additional volume and delays with US FDA approvals.