The new European regulatory framework for medical devices: opportunities for engagement by electrophysiologists

Europace. 2018 Jun 1;20(6):902-905. doi: 10.1093/europace/eux344.

Piotr Szymanski^{1

2}, Ilaria Leggeri³, Josef Kautzner^{2

4}, Alan G Fraser^{2

5

6}

¹ Institute of Cardiology, Alpejska 42, 04-628 Warsaw, Poland.
² ESC EU Regulatory Affairs Committee on Medical Devices, The European Heart House, 2035 Route des Colles, Les Templiers, 06903 Sophia Antipolis, France.
³ Advocacy and Representation Division, European Society of Cardiology, The European Heart House, 2035 Route des Colles, Les Templiers, 06903 Sophia Antipolis, France.
⁴ Institute for Clinical and Experimental Medicine, Charles University Medical School I, Videnska 1958/9, CZ-140 21 Prague, Czech Republic.
⁵ Cardiff University, Cardiff, UK.
⁶ Wales Heart Research Institute, University Hospital of Wales, Heath Park, CF14 4XN Cardiff, Wales, UK.

No abstract available

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