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.
The latest notice follows on the heels of a notice AEMPS posted in May, that informed of the set timeframes to sunset operations under the EU medical device directive. The notice eases some of the uncertainty around MDR, but NB readiness and availability remains an issue facing industry.
Germany-based TÜV SÜD became the second NB to be MDR-designated in May, joining BSI UK as the first to become MDR-designated. The EC is firm on its commitment to designate 20 more NBs by year’s end as the 26 May 2020 date of application for the new framework nears.
Other NBs, however, have notified of their decisions not to apply for designation against MDR or the EU’s in vitro diagnostic regulation (IVDR). These include London-based Lloyd’s Register Quality Assurance and Switzerland-based QS Zürich AG. Both announced their decisions just last month. AEMPS did not specify whether it intends to apply for designation against IVDR.
Gert Bos, executive director and partner at Qserve consultancy, recently told Focus that the intent with building delays into the NB process “is to clean house in the NB field and that is happening. Only a limited number of NBs have applied and resourcing will be way too thin.”