In September, the EU Commission published two significant binding documents. One concerns stricter monitoring of the Notified Bodies, while the other establishes provisions for conducting unannounced audits which, with immediate effect, must be carried out once every three years at every manufacturer. In our first article, we inform you about the implementation of this provision and its consequences.
In addition, this newsletter brings you up to date with the new Medical Device Act in Malaysia that introduces clear quality requirements for Medical Devices to this country. In Japan, by contrast, the current revision of the Medical Device Act goes far beyond these basics, preparing the country for future innovations. Our article on risk management demonstrates that many requirements in the key markets are very similar. However, on the issue of the reprocessing of Medical Devices, international approaches to the management of the associated risks still differ greatly. Last but not least, we give valuable tips for your post-marketing documentation.
I hope you find our newsletter an interesting and informative read,
Dr Peter Havel
Senior Vice President, Medical & Health Services Global
Unannounced audits: EU Commission establishes basis for unannounced audits
On September 24, 2013, the European Commission published a recommendation on audits and assessments performed in the field of Medical Devices. This recommendation also includes unannounced visits at manufacturers and their suppliers. Read more
Malaysia: First Medical Device Act in effect
The new Medical Device Act has been in effect in Malaysia since July 1, 2013, introducing the requirement to register Medical Devices. Medical Device manufacturers in Malaysia now have to register their medical devices within two years. Read more
Medical Device registration in Japan
Japan's House of Representatives is expected to pass the new law for ensuring the quality, effectiveness and safety of medicines, Medical Devices and so on this year.
IEC 60601-1:2005+A1:2012: Strategies for a successful changeover to the 3rd edition
The IEC 60601-1 has been regularly updated. The changes involved are often complex and require a higher level of compliance. The learning curve involved in understanding and complying with new standards often provides challenges to Medical Device manufacturers, which may result in costly delays to a product launch. Read more
Reprocessing of neurosurgery Medical Devices
The reprocessing of invasive neurosurgery Medical Devices involves significant risks such as cross-contamination and wear. The information on reprocessing to be provided by the manufacturer is key to the safety and functionality of reprocessed instruments. Read more
Post-market data: Checklist for complete documentation
Post-market surveillance of Medical Devices is an integral part of the European conformity assessment procedure. However, not all manufacturers know which post-market data must be included in the clinical evaluation report (CER) to ensure smooth and fast assessment of this document. Read more