News & Analysis as of September 19, 2024

European Union › Clinical Evaluations

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The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -

EU: In Vitro Diagnostic Regulation Entered Into Force (Part 3 Of 3)

MoFo Life Sciences on 6/14/2022

Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 4 Of 6)

MoFo Life Sciences on 3/11/2021

After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new risk classification regime (in part 3), in this part 4 of our...more

The European Parliament adopted a report on the Commission Proposal for a Regulation on Health Technology Assessment

Hogan Lovells on 10/18/2018

On 4 October 2018, the European Parliament adopted its Report on the Commission Proposal for a Regulation on Health Technology Assessment (HTA)....more

Rx IP Update - April 2018

Smart & Biggar on 5/4/2018

Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more

EMA publishes external guidance for clinical data publication

Hogan Lovells on 10/9/2017

On 22 September 2017, the European Medicines Agency (“EMA”) published an external guidance document concerning the implementation of Policy 0070 on the publication of clinical data for medicinal products for human use....more

EU Medical Device Regulation 2017/745 and In Vitro Diagnostic Regulation 2017/746, Pharmaceutical & Medical Device Update, Vol....

Jones Day on 6/29/2017

Following their adoption by the European Parliament in April 2017, the final versions of the Medical Devices Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") were published in the Official Journal of the...more

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