The European Commission’s Medical Device Coordination Group (MDCG) is telling medtech manufacturers to get certified under the new device and diagnostics regulations as soon as possible, in what is possibly the strongest warning to the industry yet. It is also calling on notified bodies to provide more clarity and certainty.
On 29 November, MDCG published a position paper stating that while significantly more manufacturers have applied to have their products certified under the new European Union (EU) Medical Device Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR) since several deadlines were extended, not enough are taking advantage of the new timelines. Manufacturers risk having their products dropped from the market if they do not apply promptly…
