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MDD

Brexit Update: New Notified Body Designated in The Netherlands

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The NANDO database has been updated to include the new Notified Body BSI Netherlands.
  • BSI Group The Netherlands is formally designated to carry out conformity assessments according to the MDD, AIMDD and IVDD.
  • BSI Group now has two entities, BSI UK with Notified Body number 0086 and BSI-NL with Notified Body number 2797.

Overview of new medical device regulations in Europe

The long awaited proposed Regulations for medical devices (and active implantable medical devices) and IVDs were released by the EU Commission with significant fanfare on 26 September 2012. The weaknesses cited in the Executive Summary/Impact Assessment of the EU regulatory system, were not a shock. The MDEG report (2002) had identified these as areas of concern. In reviewing the changes it became apparent to us there are several themes in the proposed legislation: Oversight of Notified Bodies, Post-market safety, Transparency and traceability, access to external expertise and management of the regulatory system. The impact of the PIP scandal was apparent.

BVMed Annual Report: Healthy Returns, but Stronger Regulatory Support for Innovation Needed

In its latest annual report, German medical device industry trade group BVMed (Bundesverband Medezintechnologie) stakes out the group’s positions on German health policy, financing issues and medical device legislation, and also provides results of BVMed’s annual membership survey.