Spain – Spanish NB Applies for EU MDR Designation

The Spanish Agency of Medicines and Medical Products (AEMPS) said Wednesday it has begun the process to become designated as a notified body (NB) against the EU’s medical device regulation (MDR).

AEMPS, or NB 0318, estimates completing the EU MDR designation process during the second half of 2020. Spain’s Ministry of Health, Consumer Affairs and Social Welfare will lead the assessment process along with a team of competent authorities representing the European Commission (EC) and other member states in verifying the NB’s capacity to conduct conformity assessment activities under MDR.

“Since the publication of the regulation, which establishes detailed and very strict criteria to become designated as a NB, AEMPS has been conscientiously preparing itself to comply with the criteria with the highest degree of technical competence, scientific rigor and professional integrity,” the notice states. The 28 June application for MDR designation underscores AEMPS’ commitment to protecting the health of its citizens that reinforces the trusts that citizens have on the legislative model of medical products, the Spanish agency adds…