Regulations tend to change due to external events and the case of the French manufacturer who used industrial silicone instead of medical grade silicone in breast implants for several years has put pressure for increased vigilance on the European Union. The European Commission has been investigating the situation since 2008 and recently issued reports and proposed changes to the 3 medical device directives, 90/385/EEC (active implantable medical devices), 93/42/EEC (medical devices), and 98/79/EC (in vitro diagnostic medical devices).
With a European Parliament June vote behind it, the EU will take action to close the flaws and gaps uncovered in the review of the breast implant case. The focus seems to be on the oversight of the Notified Bodies (independent 3rd party assessors). Specific goals for the revision of the Medical Device Directives include:
- Uniform control of Notified Bodies
- Enhanced legal clarity and coordination in the field of post-market safety
- Cross-sectoral solution of “borderline” cases
- Enhanced transparency regarding medical devices on the EU market, including their traceability
- Enhanced involvement of external scientific and clinical expertise
- Clear obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet sales
- Governance – efficient and effective management of the regulatory system
The proposed changes are considered an evolution of the current regime, keeping the same legal approach.
This legislative initiative is intended to reduce the three directives down to two regulations of the European Parliament. It is expected that the approach will continue to be supported by standardization, as well as a single registration process as opposed to multiple national requirements.
There will be 2 political choices in the implementation of the above goals. They center on whether it is better to shore up the national oversight in place now, or to create new regional level oversight. One is the transfer of the competence for the designation and monitoring of Notified Bodies to an EU body or by the Member States after involvement of “joint assessment teams” composed of assessors of other Member States and of an EU body. The other is where to locate a new Medical Device Expert Group — with the European Medicines Agency (EMA) or within the jurisdiction of an institution charged with the management of the medical device regulatory system by the European Commission (with involvement of its Joint Research Centre).
Concerns have been raised that the changes will mean a more expensive and time-consuming pre-market approval process, especially for Class IIb and III high risk medical devices.
We can expect to see close monitoring of the results of the changes, with emphasis on the development of annual incident statistics and coordinated analysis of corrective actions. There is also a push for the full implementation of the European Unique Device Identification System which is being developed in conjunction with the US FDA, among others.
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