Medical Device Registration Services - Europe

Regulatory Department

The European Commission and relevant local authority bodies in destination country

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Regulation

  • Medical Device Regulation (EU) 2017/745 (MDR (EU))

  • In Vitro Devices Directive (EU) 98/79/EC (IVDD (EU)), In Vitro Devices Regulation (EU) 2017/746) (IVDR (EU))

Regulatory Classification & Registration Process

Class I – Lowest Risk

  • Compliant with ISO 13485 requirements

  • Declaration of Conformity

  • Recognised European representative

  • Registration with the targeted country

  • Timeframe: N/A

Recognised Quality Management System

ISO 13485

Applicable Countries

France, Germany, Ireland, Italy, Belgium, Netherlands, Spain, Portugal, Luxembourg, Sweden, Finland, Austria, Poland, Hungary, Greece, Czech Republic, Slovakia, Slovenia, Latvia, Lithuania, Cyprus, Malta, Romania, Denmark, Estonia, Bulgaria, Liechtenstein, Norway, Switzerland, Turkey, Croatia, Northern Ireland, Iceland

Class Im/s/r

  • ISO 13485 Certification

  • The Conformitè Europëenne (CE) Mark Certification

  • Declaration of Conformity

  • Recognised European representative

  • Registration with the targeted country

  • Timeframe: 9 months

Class IIa

  • ISO 13485 Certification

  • The Conformitè Europëenne (CE) Mark Certification

  • Declaration of Conformity

  • Recognised European representative

  • Registration with the targeted country

  • Timeframe: 9 months

Class IIb

  • ISO 13485 Certification

  • The Conformitè Europëenne (CE) Mark Certification

  • Declaration of Conformity

  • Recognised European representative

  • Registration with the targeted country

  • Timeframe: 12 months

Class III – Highest Risk

  • ISO 13485 Certification

  • The Conformitè Europëenne (CE) Mark Certification

  • Declaration of Conformity

  • Recognised European representative

  • Registration with the targeted country

  • Timeframe: >12 months

* An European representative is required to represent overseas medical device manufacturers. We will be able to manage this for you.

Looking to register your medical device in Europe? Contact us today!