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Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

Règlements UE - DM et DIV : publication des instructions d'utilisation sur les sites Web des fabricants

Par Ronald Boumans

LES POINTS PRINCIPAUX PAR EMERGO :

  • Le RDM (ou RIM) et le RDIV européens exigent que les fabricants de dispositifs médicaux publient sur leurs sites Web les informations destinées aux utilisateurs.
  • La publication des informations destinées aux utilisateurs sur le site Web d'un fabricant rend le règlement (UE) 207/2012 sur les instructions d'emploi électroniques applicable.
  • La règlementation concernant les instructions d'emploi électroniques (e-labeling) ne s'appliquent qu'aux dispositifs médicaux, pas aux DIV.
  • Cette simple exigence peut avoir des conséquences sur les systèmes de gestion de la qualité des entreprises ainsi que sur leurs accords avec les importateurs et les distributeurs.

中国FDA重组:对于医疗器械注册者的影响。

Emergo重点摘要:

  • 中国国家食品药品监督管理总局(CFDA)正在重组为国家药品监督管理局(CDA)。
  • 新的国家市场监督管理总局将从国务院接手对于国家药品监督管理局(CDA)的管理。
  • Emergo的咨询顾问正在确定中国的监管机构是否以及将会如何对医疗器械注册登记者造成影响。

Brexit Agreement: Reset your clocks!

EMERGO SUMMARY OF KEY POINTS:

  • European and UK negotiators strike a deal
  • Transitional period until 31 December 2020: 21 months extra
  • The MDR will apply in the UK; it is likely this will also happen for the IVDR
  • A mutual agreement would enable movement of medical devices between the UK and EU, but whether this is politically achievable remains unknown

Here Come the Exoskeletons

My colleagues and I are excited by the current value and future potential of exoskeletons in healthcare. Applications of particular interest are the accommodation and treatment of partial paralysis and other types of musculoskeletal impairments, some of which are caused by a stroke.

New South Korean Guidelines for Medical Device Cybersecurity Management

EMERGO SUMMARY OF KEY POINTS:

  • South Korea’s Ministry of Science and ICT has published new guidelines for medical device cybersecurity risk management.
  • The guidelines reference UL 2900, US FDA cybersecurity guidance and related standards and recommendations in place in other medical device markets.