Case Studies

Request:

Irish company with a borderline product needed help in approaching the Health Products Regulatory Agency (HPRA). Objective was to have their product confirmed as a Medical Device and to launch into Europe.

Outcome:

We compiled evidence to support the product as a medical device and sought confirmation from the HPRA. After discussion with the agency, we were successful in obtaining medical device classification for the product and are currently working on a strategy to rollout to the rest of Europe.

Request:

A non-European medical device manufacturer requested support to achieve compliance with EU regulations in order to market their custom-made devices in Europe.

Outcome:

We delivered a regulatory strategy report which was then used as the framework to work with for achieving compliance with the appropriate regulations. EU compliant Technical Files were completed and registration with the Irish Health Products Regulatory Agency (HPRA) was successful. Currently acting as EU Authorised Representative and Person Responsible for Regulatory Compliance to ensure ongoing compliance.

Request:

A spin-out company with a novel Class IIa medical device requested guidance on their approach to the global market.

Outcome:

We helped them to define their target markets and provided them with a regulatory strategy report which was validated by in-country regulatory specialists. This report has provided them with a roadmap for their target markets and currently, we are supporting them through their implementation phase (including registrations).

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LATEST INSIGHTS

Risk Management Analysis (ISO 14971:2019)

Risk Management Analysis (ISO 14971:2019)

Medical Device Manufacturers have a legal obligation to regularly maintain and perform risk management analyses.

15.7.2022

Patient information management (IFU, Labelling and Cartons)

Patient information management (IFU, Labelling and Cartons)

A ‘Label’ is the identity of the product.

15.7.2022

Unique Device Identification (UDI) & Global Unique Device Identification Database (GUDID)

Unique Device Identification (UDI) & Global Unique Device Identification Database (GUDID)

It allows the identification of specific devices on the market and facilitates their traceability.

15.7.2022