RAPS

Navigating global regulatory pathways for orphan medical devices

Orphan medical devices are devices that are used for a small patient population due to the rarity of the indications. Due to the smaller patient population, manufacturers face unique challenges in ...
RAPS

Euro Convergence: Stakeholders seek more product-specific, technical dossier-related guidance

BERLIN – A panel of experts said stakeholders should focus on ensuring innovative and orphan devices get to market and keep digitalization in mind as they transition to the EU Medical Device ...
JD Supra

Medical Devices in the EU: MDD Certificates Remain Valid - the EU Extends Transition Periods for MDR Compliance, and Sell-Off Dates for Devices Under MDD and IVDD Fall Away!

Today, on Monday, March 20, 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council of March 15, 2023, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards transitional ...
JD Supra

EU moves to align Notified Bodies’ practices under the MDR and IVDR

DigiCure: Legal insights at the intersection of Technology and Life Sciences and Health Care On 4 May 2026, the European Commission adopted Commission Implementing Regulation (EU) 2026/977, ...
Yahoo Finance

Aphranel® MagiCCrystal CaHA Filler Achieves EU MDR Certification as a Premium Regenerative Injectable

SHANGHAI, May 28, 2026 /PRNewswire/ -- Moyom Biotechnology announced that its premium regenerative aesthetics product, Aphranel® MagiCCrystal CaHA Filler officially achieved European Union Medical ...