Medical device manufacturers who want to bring their devices onto the Union market, must understand three essential elements when complying to the MDD. Device manufacturers that want to enter into the EU Market need to understand three essential ideas: the role of the competent authorities, contract with an EU Authorised Representative, and how to use harmonized standards.
The primary role of the competent authorities is to protect the public health by ensuring that medicines and medical devices, entering into their respective Member States are safe and effective. Competent authorities also provide guidance to Notified Bodies that operate within the borders of each Member State. Another vital role for the competent authorities is the postmarket surveillance and vigilance reporting. Finally, it is imperative that competent authorities cooperate with each other. Exchanging of vigilance, incident, and post-market surveillance information is an important requirement of the Directive.
European Authorised Representative
Device manufacturers that do not have a manufacturing presence within the EU, must contract a European Authorised Representative. Similar to a requirement imposed by FDA, the EU Authorized Representative is essentially the registered agent for a medical device manufacturer.
The Authorized Representative must:
- Be the interface with the competent authorities for device incidents (vigilance reporting).
- Act as an intermediary between the medical device manufacturer and the competent authorities.
- Be responsible for incident reporting and field safety corrective action (FSCA) reporting.
- Register medical devices with the national competent authorities.
- Authorise the device manufacturer, through contracting, the use of their name and address on the product labelling.
- Maintain a file copy of the technical documentation and design dossiers.
- Maintain reports associated with the execution and performance of clinical evaluations.
One thing which is always certain when dealing with European Harmonised Standards, is that standards are constantly changing. Significant changes were made to harmonised standards in 2012 and early 2013.
According to the European Commission: “compliance with harmonised 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 however trying to get a product application approved without using them, is nearly impossible.
Certification Experts has many experience in guiding and supporting companies in the CE Process. We will investigate available documentation, test your medical devices and support you throughout the whole process.
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