Medical Device Registration

PDS generates submissions for medical devices of all classes.

Class I devices

Including both sterile,non-sterile and measuring function, PDS can:

• Provide general pre-CE marking assistance by reviewing your product, determining its device classification and route to conformance
• Assist with technical file preparation and maintenance
• Provide advice on labels, arrange translations and check compliance, claims and instructions
• Help ensure QA compliance including operating procedure advice and writing, as needed

Class II and III devices

• Advise and assist you with regulatory matters and liaise with the Notified Body from initiation to completion of the CE-marking process
• Preparation and submission of documentation to support clinical investigations or studies

Services for device manufacturers located outside the EU

• All non-EU based device manufacturers require an authorised representative located within the EU
• PDS acts as an authorised representative for device manufacturers based outside the EU – In this role, PDS maintain a watching brief on all matters of concern to the client, including regulatory updates
• PDS also liaise with competent authorities in regards to vigilance matters
• PDS advise, assist, and submit adverse incident reports as required to the relevant competent authorities on behalf of our clients