Registration is mandatory only for Manufacturers/Authorised Representatives having their place of business in Cyprus.

For Medical Devices (Regulation (EU) 2017/745)

Class I medical devices:

For registration the following must be submitted to CYMDA:

• Registration form
• The Technical Documentation of the product, as defined in Annex II of Regulation (EU) 2017/745
• Documentation for establishing, implementing, maintaining, keeping up to date and continually improving a quality management system.
• EU declaration of conformity

Class IIa, IIb, and III medical devices:

For registration the following must be submitted to CYMDA:

• Company’s contact details and person’s responsible for regulatory compliance (article 15 of Regulation (EU) 2017/745)
• Appropriate certificates from a Notified Body
• Documentation for establishing, implementing, maintaining, keeping up to date and continually improving a quality management system.
• EU declaration of conformity

For in vitro diagnostic medical devices (Regulation (EU) 2017/746)

Class A in vitro medical devices

For registration the following must be submitted to CYMDA:

• Registration form
• The Technical Documentation of the product, as defined in Annex II of Regulation (EU) 2017/746
• Documentation for establishing, implementing, maintaining, keeping up to date and continually improving a quality management system.

Class B, C and D in vitro medical devices:

For registration the following must be submitted to CYMDA:

• Company’s contact details and person’s responsible for regulatory compliance (article 15 of Regulation (EU) 2017/746)
• Appropriate certificates from a Notified Body
• Documentation for establishing, implementing, maintaining, keeping up to date and continually improving a quality management system.
• EU declaration of conformity