MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Medical devices: UK approved bodies

UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)...

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The US Food and Drug Administration’s (FDA) has issued draft guidance proposing that devices be deemed adulterated and refused entry to the US market...
Institutional Review Board (IRB) submissions: Necessary for usability tests?

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...
COVID-19 outbreak: the presidency steps up EU response by triggering full activation mode of IPCR

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)...
Double peine pour la medtech suisse

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...
EU MDR/IVDR: European Commissioner Looks to Quash Transition Concerns

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...
DEKRA accredited under the MDR

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...
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

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...
Norway’s DNV GL Designated as 10th Notified Body Under MDRClinical Trials With Conditions

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...

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