USA – FDA guidance proposes devices be deemed adulterated for refusing inspections
The US Food and Drug Administration’s (FDA) has issued draft guidance proposing that devices be deemed adulterated and refused entry to the US market...
USA – New US FDA Guidance on Human Factors Engineering for Medical Devices
The US Food and Drug Administration has issued a new draft human factors engineering (HFE) guidance this week titled: Content of Human Factors Information in...
Europe – European Commission Proposes Extending MDR, IVDR Transition Periods
At the EPSCO Health Council on 14 June 2022, Health Ministers expressed their concerns that severe challenges related to the implementation of Regulation (EU)...
Switzerland – Swiss Regulators Set To Recognize US FDA-Cleared or Approved Medical Devices
Swiss legislators have authorized adoption of new laws to recognize medical devices and in vitro diagnostic (IVD) devices that have received US Food and...
Europe – Manual on borderline and classification for medical devices under Regulation (EU) 2017/745...
Determining whether a given product falls under the definition of a medical device and the
application of the classification rules fall within the competence of...
Europe – MDCG 2022-4 Rev.1 Guidance on appropriate surveillance regarding the transitional provisions under...
Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state that
devices which are covered by valid certificates issued by a notified...
Europe – MDCG 2022-21 Guidance on periodic safety update report (PSUR) according to regulation...
The Periodic Safety Update Report (PSUR) has been introduced in Article 86 of the Medical
Device Regulation (MDR) 2017/745. The introduction of the PSUR requirement...
Europe – MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746
The sponsor of a performance study is required to submit an application/notification1 to the Member State(s) in which a performance study is to be...
Europe – EU issues implementing regs for devices without an intended medical purpose
Regulation (EU) 2017/745 lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices...
USA – FDA proposes framework for human factors information in device submissions
The US Food and Drug Administration (FDA) last week issued draft guidance outlining a risk-based framework about what human factors information should be included...
