Recently the MDCG (Medical Device Coordination Group) published a guidance on the content of the…
Regulatory lookout: Which other new regulations may be applicable to medtech manufacturers?
The EU is preparing and implementing several new legislations that may impact medical device manufacturers…
MDR & IVDR national implementation: Malta
The Medicines Act 2020 “Medical Devices and In-Vitro diagnostic Medical Devices Provision on the Maltese…
Q&A on extension of the MDR transitional period and removal of the “sell off” period
Following the publication of the latest amendment to the Medical Devices Regulations (MDR and IVDR),…
MDCG Guidance on Period Safety Update Report (PSUR) under MDR
Manufacturers of class IIa, class IIb, and class III medical devices have to prepare a…
MDCG Position Paper on extension period for legacy devices
The previous 2024 deadline worried the medical devices sector. With foreseeable market disruptions and negative…
Notified Bodies: requirements, certifications, and applications
Several publications related to notified bodies marked October 2022. Among others, the Medical Device Coordination…
MDR: 34 Notified Bodies on NANDO
The NANDO database newly listed 34 Notified Bodies under the MDR! ENTE CERTIFICAZIONE MACCHINE SRL…
MDR: 33 Notified Bodies on NANDO
The NANDO database newly listed 33 Notified Bodies under the MDR! POLSKIE CENTRUM BADAN I…
Reclassification of products without an intended medical purpose: European Commission publishes a draft act
The new draft act available on the website of the European Commission aims at regulating…