How do you launch a medical device in the European Union if you do not have a business based there?
In addition to all the technical requirements that a product launch entails, manufacturers with a registered office outside the EU must appoint an authorised representative based in the EU. This partner is available as an interface to or contact person for the authorities. This applies to the first launch, the declaration of conformity and consequently also to the CE marking.
In the first part of this blog (EU Authorised representatives: A question of acceptance) we discussed the challenges faced by EU authorised representatives in the medical device sector, based on the new Medical Device Regulation (MDR) and forthcoming Invitro Device Regulation (IVDR). In this second part we showcase the Lorit Consultancy skills and how we can support customers as the EU authorised representative.
Technical file management
With many years’ experience in safety and risk management, we support our customers with managing their technical files. Reviews and support with technical files come in many different forms, whereby we support you with our expertise in the following areas:
- Risk analysis experience including Hazard and Operability Study (HAZOP), Failure Modes and Effects Analysis (FMEA), Fault-Tree Analysis (FTA) and System Theoretic-Process Analysis (STPA)
- Safety experience over many years in multiple industries
- Software experience in many different languages from requirements to verification and validation
- Hardware experience in a wider variety of products and industries
- EMC experience with many different products
- Many years consultancy experience with medical and invitro products
- Experience with market launch in various sectors including EU, US, UK and Australia
- Ongoing monitoring of technical changes that may impact customers projects: Software of unknown provenance (SOUP) or cybersecurity changes
- Ongoing monitoring of the international standards landscape
With the above list of experience, we can support you with a detailed review of your technical file, generation and review of your declaration of conformity.
The requirements were added to the MDR and forthcoming IVDR. The items defined in Article 11 require a timely dialogue between the EU authorised representative and competent authority, likewise between the EU authorised representative and manufacturer. With our many years in consultancy we are experts in delivering timely updates and reports as required. This can be feedback from monitoring the regulatory landscape or feedback based on the product implementation itself.
We shall maintain your technical files in a secure location and feedback to you as soon as relevant changes in the regulatory landscape have occurred.
We as a team have the necessary qualifications to fulfil the EU authorised representative for the MDR and IVDR. We also as an international organisation have experience of many markets outside the EU and hence are very familiar with working practices in these markets, which aids the cooperation between manufacturers and our team. We can support you with the gap analysis between the different regions and the EU.
As part of our consultancy activities, we operate in multiple industry sectors and are frequently involved in projects utilising the low-voltage, machinery, general product safety (GPSD), electromagnetic compatibility (EMC), waste electrical & electronic equipment (WEEE) and restriction of hazardous substances (RoHS) directives hence enabling us to support customers in multiple projects and industries.
We would be delighted to discuss your requirements and work with you to launch your product in the EU.
By Alastair Walker, Consultant & Owner
Are you looking for an EU authorised representative who supports you as your interface to the competent authority, informing you of the current market position and supporting your technical file management? Please contact us at firstname.lastname@example.org
Wir freuen uns auf Ihre Kontaktaufnahme.