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Informa MedDev >profile  Check out the speaker line up for next weeks #Biocompatibility for #MedicalDevices conference in #Berlin - https://t.co/BMY6OJnLGN #MedDev 3 days ago. · reply · retweet · favorite
Informa MedDev >profile  See who's attending #Biocompatibility for #MedicalDevices in Berlin next week - https://t.co/yLe2B0eKVg #MedTech #ISO10993 3 days ago. · reply · retweet · favorite
Informa MedDev >profile  Get clarification on the newly introduced Rule 21 on the classification of substance-based #devices - https://t.co/cUuDHShiEx #DDCP #MedTech 3 days ago. · reply · retweet · favorite
Informa MedDev >profile  Get the latest @US_FDA regulatory updates & requirements for #drugdevice #combinationproducts next week - https://t.co/jQek0OE7dx #DDCP 4 days ago. · reply · retweet · favorite
Informa MedDev >profile  Get the latest status updates of ISO/TR 10993-22 & expectations for #nanomaterials at #Biocompatibility for #MedDev https://t.co/bqGgGOkQQQ 4 days ago. · reply · retweet · favorite
Informa MedDev >profile  Understand the power of material characterisation for #biological evaluation of #medicaldevice wearables @ULTSnews - https://t.co/LNWRbP4KqQ 7 days ago. · reply · retweet · favorite
Informa MedDev >profile  Hear from @sanofi on 'Human factors engineering & requirements engineering – 2 competing disciplines?' https://t.co/WG1w3JOOV5 #DDCP #MedDev 8 days ago. · reply · retweet · favorite
Informa MedDev >profile  Hear from @BayerPharma on #biocompatibility testing & evaluation requirements for #drugdevice #combinationproducts - https://t.co/rdanRdmpuz 8 days ago. · reply · retweet · favorite
Speakers 2015
Speakers 2015
Rosalind Polley Senior Medical Device Specialist Medicines and Healthcare Products Regulatory Agency (MHRA),
Alex Laan Principal Certification Manager DEKRA Certification B. V.
Marta Carnielli Manager, Safety Risk Management & Surveillance Ortho Clinical Diagnostics
Simon Richards VP, Regulatory Affairs Alere
Qarad - Implementing e-labelling
Qarad - Implementing e-labelling - practical issues
4 Notified Bodies

Feedback, clarification and insight from LRQA,  TÜV SÜD, LNE/GMED and DEKRA

2 Competent Authorities

First hand feedback, updates and insight on the IVD regulation from:

- UK

- Ireland

Scientific Institute of Public Health
Industry benchmarking

Rare industry benchmarking opportunities with speakers and attendees from across large, medium and small IVD manufacturers

Interactive sessions

Panel discussion

World Cafe


In Vitro Diagnostics conference: The IVD Regulatory and Strategic Forum

An IVD industry dedicated event: 8th-9th December 2015

Providing the latest regulatory updates and key industry feedback from leading IVD manufacturers within this complex and ever-changing landscape

Delegate Feedback

  “Interesting update on current status of the new regulation.Numerous practical cases and examples” Delegate 2014,Ortho Clinical Diagnostics

“ Interesting, both CA and NB and manufacturers point of view is taken into account” Delegate 2014, Fujirebio Europe

Why should you attend?

  • Find out how close we are to a final text of theIVD regulation from the MHRA


  • Prepare for the impact of the New IVD Regulationwith the VP of Alere


  • Direct your questions to our expert panel ofNotified Body representatives including LRQA, TUV SUD, LNE/GMED and DEKRA


  • Gain a comprehensive understanding with HPRA on how to effectively comply with the increased requirements for post market surveillance


  • Examine how to work together as economic operators with feedback from Beckman Coulter


Do you agree with the changes in IVD classifications?



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