One device, endless markets. Requirements are more complex than ever.

Regulatory Affairs Consulting

If you want to market in a particular country, but are not sure what regulation applies and what you need to do to sell there, let us do the leg work for you.

Despite attempts at global harmonisation, international regulatory requirements are as complex as ever.

Expand your distribution.

  • At a minimum, you’ll need a compliant quality management system and technical documentation. Depending on the risk classification of the device, you will need a CE certificate from a notified body. After assessment is complete, you can sign a Declaration of Conformity.

  • The US operates on similar general principles to the EU - the level of assessment depends on the risk classification of the device.

    However, whereas the EU uses a rules based classification system, the US uses a list or precedent based classification system.

    The FDA will likely need to conduct an on-site inspection, unless you have an MDSAP certificate with the US in scope. The FDA also have pathways for assessment of technical files, which depend on the type and classification of the device.

  • In most cases no. The UK currently accepts EU MDR or IVDR (CE) certification, with some additional requirements for a UK representative and post market reporting.

    The UK is currently consulting on indefinite recognition of EU certification.

OUR PEOPLE

Joseph Langley MEng CEng MTOPRA

Design - Manufacturing - Quality - Regulatory - Management

Underpinned by 7 years at a leading notified body.

DIRECTOR

Bio

Entering “rest of world” markets beyond the EU, UK and US remains complex. Sometimes you just need an extra pair of hands to research and plan how to get there.

Services

Every engagement is unique, and we tailor a bespoke set of deliverables to every project.

Three levels of service:

  1. Research target market(s)

    You give us your commercial goals, and we investigate the regulatory landscape in those markets.

  2. +Go-to-market plan

    A plan for the device(s) and desired market(s), identifying the applicable legislations in each country, the route through any required assessment, registration requirements, post market reporting requirements, and sourcing in-country legislation.

  3. +Management of the application process

    Writing and compilation of any necessary regulatory submission, response to the healthcare authority’s questions, registration, and working with the in-country representative.

  • This varies. For example the UK currently recognises CE marking as a route to market - but also imposes their own post market reporting requirements.

    Some countries view CE marking a basis for entry, but there is still a prescribed process to go through.

    This highlights the complexity of global regulatory requirements. Each device needs thorough consideration for entry into target markets.

  • In compiling EU technical documentation, you’ve drawn together all of the relevant materials, but they likely need to be presented in different ways. For example, Health Canada now require electronic submission of documents, typically in an Electronic Common Technical Document (eCTD) format.

  • In almost all cases, yes. The terminology varies. The US FDA requires you to have a US Agent. The UK requires you to have a UK Responsible Person. The EU leverages the union, and you only need a single EU Representative to act for you across the EU.

    If you’re a multinational with an entity in the target country, you can often use it. However, even multinationals are often turning to third parties that specialise in in-country representation.

Expand your reach.

Enquiries

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