Medtech Insight

Spanish Law Details Where National Medical Device Rules Differ From Elsewhere In EU

14 Apr 2023

Has Spain overstepped the mark by introducing specific national requirements that exceed those permitted under the EU’s Medical Device Regulation? Medtech Insight spoke to local medtech consultant and device auditor Carmen Martin.

In March, Spain published a 36-page Royal Decree, PS 1/2023, which outlines how the country’s medtech regulations may diverge from requirements in other EU countries.

The new medical device text, PS 1/2023 is intended to deal with areas that are the remit of individual national...