The EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) have been fully applicable in the EU since 26 May 2021 and 26 May 2022, respectively. These regulations replaced the older directives, the MDD and IVDD. This means that any new devices placed on the EU market must be compliant and CE marked in accordance with the new MDR and IVDR. There are some extended transitional periods in place for devices that were on the market that are transitioning to the new regulations, due largely to the lack of notified body capacity for conformity assessments.

 We can help you:

• Navigate the transition from the old MDD/IVDD to the new MDR/IVDR, utilising any transitional periods.
• Re-classify your device under the updated classification rules.
•  Author MDR and IVDR compliant technical documentation. 

Since 1 January 2021, Great Britain (England, Wales and Scotland) has not followed the EU medical device regulatory framework. Instead, medical devices in Great Britain are regulated through the Medical Devices Regulations 2002 which effectively follows the old EU directives, the MDD and IVDD. Under this framework, medical devices that are compliant with the regulation should have the UKCA mark applied; however, there are transitional periods in place for the extended use of CE marking in Great Britain. In addition, in cases where the legal manufacturer is not based in the UK, they must appoint a UK responsible person to act on their behalf in the market.

 We can help you:

•        Ensure that your technical documentation is compliant with the Medical Device Regulation 2002.
•        Apply UKCA marking and utilise any transition periods for the extended use of CE marking in GB.
•        With UK responsible person services.

 Due to the terms of the Northern Ireland Protocol, medical devices that are placed on the market in Northern Ireland will follow the EU regulations (MDR and IVDR). 

All medical devices placed on the market in the EU or UK are required to have technical documentation that is compliant with the requirements of the respective regulations. The Rubicon team can help you gather and author the required technical documentation to fulfil your legal obligations and pass a technical file audit. We can also assist with ongoing lifecycle management of the technical file, ensuring theat

We can help you:

•        Author medical device technical documentation.
•        Apply ISO 14971 to your risk assessment process.  
•        Sign off your clinical evaluation report with our consultant medical doctor.

We also go above and beyond by assisting with registering manufacturing sites. We know that each site may have its own unique set of requirements, which is why we handle this process on a case-by-case basis to ensure compliance with all regulations.

Legal manufacturers that are based outside of the EU and/or UK are required to appoint an EU authorised representative and/or UK responsible person, respectively. The role of the authorised representative and responsible person is to represent the legal manufacturer in that market and fulfil any obligations such as device registration with the competent authority as well as having their name and address appear on the labelling of the device.

 We offer:

•         UK responsible person services from our UK office.
•        EU authorised representative services from our Netherlands office.
•        Advice on when you need a UK responsible person or EU authorised representative.