Modification of ISO 13485 - new Annexes ZA, ZB and ZC
In order to adjust to the current EU-Directives (90/385/EEC, 93/42/EEC and 98/79/EC) for medical devices, EN ISO 13485 will be modified. Many manufacturers of medical devices are certified according to EN ISO 13485 as basis for their management system for the development and production of medical devices. Read on here.
QP for Manufacturers of Medical Devices - New EU Requirement?
Article 13 of the proposal for a regulation concerning the new regulatory framework for medical devices introduces a new role for manufacturers of medical devices: A person responsible for regulatory compliance. This function, referred to as "qualified person", involves certain requirements as well as responsibilities. Find out more.
FDA publishes Proposals on Harmonised Identification of Medical Devices (UDI)
In July 2012, the FDA announced via its Center for Devices and Radiological Health (CDRH) - which is also responsible for medical devices - the publication of requirements on harmonised designation of medical devices (Unique Device Identification System, UDI system). The Congress had already enacted a law in 2007. A draft is now available.
IEC 60601-1 valid in 3rd Version since June 2012 - Risk Management playing important Role
After a long transitional period the Norm IEC 60601-1 with regard to security requirements and ergonomical demands for medical devices has become effective as Version 3 on 1 June 2012. Specifically interesting in this new version is the topic risk management. Read more.
Will there be a Registration Obligation for critical Medical Devices?
Following the PIP scandal the EU currently deals more intensively with the planned revision of medical devices regulation. In a resolution the European Parliament has now proposed various measures to eliminate the "system's malfunctions on a European and a national level". Read on.
Will there be an Authorisation Obligation for Critical Medical Devices?
Since the PIP scandal, the EU has been working on strengthening the planned revision of the Medical Devices Guidelines. The European Parliament has proposed different measures in a resolution to get rid of the "malfunctioning of the system at European and national levels". Read more here.
FDA Compliance Programme Guidance on Inspections of Medical Devices Manufacturers
Medical device manufacturers "fear" FDA inspections as well. Companies which have never had an FDA inspection often don't know how such an inspection is performed. They can find support in an FDA Manual published last year.
New FDA Online Training on GMP for Medical Devices
What are FDA's requirements regarding medical devices? The FDA itself gives a partial answer to this question. At the end of last year and at the beginning of this year, the FDA has been making an extensive update of its online training available on CDRH's (Center for Devices and Radiological Health) medical devices homepage. Read more here.
Medical Devices: European Commission calls for Immediate Actions - Tighten Controls, Increase Surveillance
The European Commission has published a press release from the Commissioner for Health and Consumer Policy. This press release is entitled "Medical devices: European Commission calls for immediate actions - tighten controls, increase surveillance, restore confidence". Read more here.