The primary role of the competent authorities is to protect the public health by ensuring medicines and devices entering into their respective Member States are safe and effective. Competent authorities also provide guidance for the notified bodies that operate within the borders of each Member State. Another vital role for the competent authorities is postmarket surveillance and vigilance reporting, in accordance with MEDDEV 2.12-1, Rev 8. Competent authorities are responsible for reviewing vigilance reports and the notification to device manufacturers when incidents occur. Assessment of risk associated with an incident, the need for corrective action by manufacturer, and the monitoring of a manufacturer’s investigation of device-related incidents are also important duties performed. Finally, it is imperative that competent authorities, as delineated within Article 21a, cooperate with each other. Exchanging of vigilance, incident, and post-market surveillance information is an important requirement of the directive.
European Authorized Representative
Device manufacturers that do not have a manufacturing presence within the EU must contract with a European authorized representative. Similar to a requirement imposed by FDA, the EU authorized rep is essentially the registered agent for a device manufacturer. The authorized rep must:
- Be the interface with the competent authorities for device incidents (vigilance reporting).
- Act as an intermediary between the device manufacturer and the competent authorities.
- Be responsible for incident reporting and field safety corrective action (FSCA) reporting.
- Register devices with the national competent authorities.
- Authorize the device manufacturer, through contracting, the use of their name and address on the product labeling.
- Maintain a file copy of the technical files and design dossiers.
- Maintain reports associated with the execution and performance of clinical evaluations.
One thing that is always certain when dealing with European Harmonized Standards is that standards are constantly changing. Significant changes were made to harmonized standards in 2012 and early 2013 such as the change to EN ISO 14971:2009 and EN ISO 13485:2003, each of which now have a 2012 version. Further, EN 980:2008 was withdrawn and replaced with EN ISO 15223-1:2012. These types of rescripts are commonplace within the EU. According to the European Commission, “compliance with harmonized standards provides a presumption of conformity with the corresponding requirements of harmonization legislation. Manufacturers, other economic operators or conformity assessment bodies can use harmonized standards to demonstrate that products, services or processes comply with relevant EU legislation.”
Yes, harmonized standards are optional but just try to get a product application approved not using them. It is nearly impossible.