11
Jun
Medical devices and in-vitro medical devices: News and forthcoming provisions
In recent days there have been developments in the regulatory framework for medical devices and in-vitro medical devices via the proposal of the European Commission for the amendment of the MDR and the IVDR and the new guidance of the MDCG.
3
Apr
Article 22 EUMR is still up in the air: Advocate General’s opinion in the Illumina/Grail saga
Advocate General Nicholas Emiliou advised setting aside the General Court’s judgment and annulling the decision of the European Commission to accept the request from certain Member States to review the transaction under Article 22 of the EU Merger Regulation.
20
Jun 23
European Commission proposals for new regulation of compulsory licensing
On April 27, 2023, the European Commission published proposals for a new set of regulations aimed at establishing a more transparent and effective framework for patent rights.
5
Dec 22
The European Commission sends a Statement of Objection to a drug manufacturer accusing it of regulatory gaming and denigration of competitors in breach of Article 102 TFEU
On October 10, 2022, the European Commission sent a Statement of Objection to Teva accusing the company of denigrating a competing product and of “regulatory gaming” in management of the life cycle of its multiple sclerosis drug Capoxone, conduct deemed abusive pursuant to Article 102 of the Treaty on the Functioning of the European Union.
7
Feb 22
Digitization of Instructions for Use: the European Commission has endorsed a new Implementing Regulation on the use of electronic instructions for use (eIFUs) of medical devices
On December 14 2021, the European Commission adopted a new Implementing Regulation (EU) 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council relating to electronic instructions for use of medical devices.
4
Feb 22
IVD devices: Extension of timelines for the application of Regulation (EU) 2017/746
Regulation (EU) 2022/112 of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices was published on January 25, 2022.
