Our Medical Devices Services

We can help

Rubicon Technical is a leading company providing comprehensive regulatory services for medical devices. Our team of experts has years of experience in navigating the complex regulatory landscape and helping clients bring their products to market efficiently and effectively.

With our deep understanding of the regulatory requirements and processes, we are able to guide our clients through every step of the regulatory journey.

We can help with:

EU MDR and IVDR Compliance

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. 

UK Medical Device Compliance

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). 

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Authoring Technical Documentation

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.

EU Authorised Representative and UK Responsible Person

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. 

Borderlines and Classification

       All medical devices must be classified in accordance with the classification rules in the relevant legislation. The classification of a device is crucial in deciding what route to market applies for your product, and it is a key step in the medical device regulatory process. Classification rules are changing as a result of the MDD/IVDD to MDR/IVDR transition and it is important to correctly classify your device to ensure continued compliance and sales.
 
Medical devices share a borderline with other product types that fall under different regulatory regimes, including medicinal products, cosmetics and biocides. Ensuring your product is compliant with the relevant legislation ensures an unhindered market entry. Rubicon can assist in identifying the correct regulatory framework in borderline cases.

We can help you:

  •         Classify your medical device for the EU and UK markets.
  •        Navigate the borderline between different regulatory frameworks.
  •        Understand the legal obligations for your product to help ensure smooth market access. 

 

Contact Us:

Need our help? Get in touch today to see which of our services is most suitable for your medical devices needs.

Rubicon Technical UK

C4DI @ The Dock, 31-38 Queen Street, Hull, HU1 1UU

Email: info@rubicontechnical.co.uk

Call us: 01482 702726

Rubicon Technical Netherlands

Keizersgracht 555, Amsterdam, 1017 DR,
Netherlands

Email: info@rubicontechnical.nl

Call us: +31 20 3085473