Europe

ARTICLES

EU Notified Body Extends Deadline for MEDDEV Rev. 4 Implementation

European notified body TÜV SÜD said it will extend the implementation date for the MEDDEV 2.7/1 Rev. 4 guideline on clinical evaluations for device manufacturers and notified bodies. Read More

Phase-in of New Device Regulations Extends Beyond Brexit

UK regulators have outlined the schedule for phasing in new European Union regulations on medical devices – although the UK will no longer be in the EU by the time the regulations take full effect. Read More

Sweden Issues Guidance on Notified Bodies

Sweden’s Medical Products Agency issued guidance on the new EU procedures for appointing a notified body that will go into effect on Nov. 26. The agency promised to issue further updates when there’s “more clarity around notified bodies in the EU.” Read More

Irish Notified Body Advises Embracing Global Standards as Brexit Looms

Ireland’s national standards organization and notified body is advising devicemakers to become certified to global standards to get ahead of uncertainty surrounding Brexit. Read More

MHRA Pelvic Mesh Group Finds Risk Information is Key Issue

The UK’s Medicines and Healthcare products Regulatory Agency released final recommendations from the Mesh Oversight Group, which concluded hospitals need to improve their processes for tracking data and patients need to be better informed about potential risks of pelvic mesh devices. Read More

EMA Seeks Stakeholder Comments on Companion Diagnostics

The EMA released a concept paper that will form the basis of a new guideline on companion diagnostics. Read More

Dutch Regulators to Adopt FDA’s UDI Device-Labeling System

The Dutch medical device authority has reached a voluntary agreement with industry on the use of UDI codes for medical devices, using FDA’s UDI system as a template. Read More

Regulatory Expert Gert Bos Shares Insights on Europe’s Notified Bodies

Devicemakers are closely watching the EMA and the U.K.’s Medicines and Healthcare products Regulatory Agency for assurances on how conformity assessments will unfold under the new EU regulations. With fewer notified bodies in the EU, and the added complication of Brexit, the next steps remain uncertain. Qserve Group Executive Director Gert Bos — an auditor and former head of a notified body — spoke with IDDM on the changing environment and how devicemakers can plan for upcoming conformity assessments. Read More

MHRA Updates Guidance on UK Notified Bodies

In a decision associated with the United Kingdom’s withdrawal from the European Union, the UK’s Medicines & Healthcare products Regulatory Agency issued updated guidance with new links to notified bodies permitted to undertake conformity assessments of medical devices in the UK. Read More

HPRA Issues Guidance on Device Standalone Software

Ireland’s Health Products Regulatory Authority released new guidance on medical device standalone software. Read More