Dive Brief:
- The Spanish Agency of Medicines and Medical Products (AEMPS) has begun the process to become designated as a notified body under the European Union’s medical device regulation (MDR), it announced last week.
- The agency’s decision will support implementation of the MDR at a time when some fear a shortage of notified body capacity to handle the transition.
- AEMPS said it expects to complete the MDR evaluation and designation process during the second half of 2020.
Dive Insight:
Medtech companies are preparing for a medical device and diagnostics regulatory overhaul in the EU that tightens controls for product safety and performance and brings tougher requirements for notified bodies, which are organizations designated by an EU country to assess products before they can be marketed.
The MDR is phasing in during a three-year transition period that gives medical device manufacturers until May 26, 2020 to complete product recertification to continue European sales. The in vitro diagnostics regulation has a five-year transition to May 26, 2022.
Notified bodies are in the process of being reaccredited for the new rules, raising concerns about whether there will be enough agencies to handle the work of performing conformity assessments for CE marking for thousands of devices. In June, the German and Irish delegations to the European Council flagged the issue of availability of notified bodies ahead of a key meeting. Germany and Ireland are the two biggest net exporters of medical devices in the EU.
QS Zürich and Lloyd’s Register Quality Assurance last month became the latest notified bodies to indicate they would withdraw the service ahead of the implementation of the new medical device rules.
Spain’s Ministry of Health, Consumer Affairs and Social Welfare will conduct the evaluation process, AEMPS wrote. A joint evaluation team of experts representing the European Commission and other member states also will be involved to verify the agency’s capacity to carry out conformity assessment activities, it added.
