Oct 23, 2012
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.
While the European medical device regulatory system remains largely intact, greater detail has been added, and new mechanisms exist to bolster the weaknesses. The legislation is a regulation which applies as drafted to all member states and at the same time. The days of subsidiarity and member state autonomy are over though each member state is required to nominate a member and alternate to the Medical Device Coordination Group (MDCG). Here is a high level overview of the primary changes. Download our white paper if you want an in-depth analysis of the new European medical device changes.
The changes are expected to go into effect in three years from date of publication of the Regulations in the OJEU. It has been mentioned that this is expected to be published in 2014, with an effective date at the earliest of 2017. From our perspective, the changes are far reaching but beneficial. You can read much more about the changes by downloading our free PDF entitled "Europe's Proposed Medical Device Regulation."
The European Society of Cardiology (ESC) has published a position pap
A new report examining European in vitro diagnostic (IVD) market performance in 2010 sees flat or negative growth across most major EU member states due to cost containment measures and worsening economic conditions.
According to the European Diagnostic Manufacturers Association’s (EDMA) study, the European IVD market totaled €10.5 billion last year, with revenue growth of only two percent from 2009. Cardiology testing and diabetes-related IVD sectors as well as products for managing hospital-acquired infections showed the strongest growth rates in 2010, but all other testing areas showed flat or negative growth.