Built by people who studied the problem first

Medarro started from a simple observation: regulatory affairs consultants in Ireland — some of the most qualified people in European medtech — were spending four to eight hours per client file doing work that is fundamentally mechanical. Cross-referencing a published checklist against a document stack. Finding what is missing.

That work is not where their expertise lives. Their expertise is in knowing what to do about the gaps — how to write a credible PMCF plan, how to structure a clinical evaluation that a Notified Body will accept, how to navigate the specific preferences of different Notified Bodies. That is the work only they can do.

Medarro handles the checklist. So consultants can get back to the work that requires their expertise.

Why the MDR created a compliance crisis

The EU Medical Device Regulation replaced the older Medical Device Directive in 2021 and represented the most significant overhaul of European device regulation in over twenty years. The intent was to raise safety standards. The effect was a documentation and compliance crisis that is actively shrinking the European medtech market.

Technical Files under the new regulation are substantially more demanding than their predecessors. The requirements around clinical evaluation, post-market surveillance, cybersecurity, and software documentation are all significantly stricter. Small manufacturers who were compliant under the old directive often find themselves starting from near-zero under the MDR.

And yet the Notified Body bottleneck means there is no margin for error. A rejected submission does not get a second review in the same queue — it restarts the clock on a twelve to eighteen month wait. Every gap that Medarro catches before submission is a potential year saved.

Who Medarro is built for

Medarro is built for freelance and boutique EU MDR regulatory affairs consultants — the professionals who sit between small manufacturers and Notified Bodies, guiding them through the Technical File preparation process.

These consultants typically have seven to fifteen years of industry experience, manage four to ten active clients simultaneously, and bill at rates between €150 and €300 per hour. They are not short of expertise. They are short of time to apply it.

Medarro does not try to replace them. It tries to give them four hours back per client file — every round, every submission cycle.

Ireland is the largest medtech employer per capita in Europe. Nine of the world's top ten medical device companies have a presence here. The cluster around Galway, Limerick, and Dublin represents the densest concentration of medtech expertise in the EU.

That means the regulatory affairs consultant market in Ireland is not a small niche — it is a professional community of hundreds of people who know each other, attend the same conferences, and share information through the same networks.

Building Medarro in Ireland is not just convenient geography. It is the fastest path to the customers who can tell us whether the product is working.

Technical Files contain device specifications, clinical data, and risk analysis that represent the most sensitive intellectual property a medical device manufacturer holds. We treat that seriously.

Every document upload to Medarro is encrypted in transit using TLS 1.3 and at rest using AES-256. Access to stored reports requires authentication. We do not use your uploaded content to train models.

If you are a regulatory affairs consultant unsure how to frame Medarro's use to your clients, our Data Processing Agreement template includes language your clients can review before any documents are uploaded.

Questions about data handling should be directed to privacy@medarro.ie

Medarro is a documentation completeness tool. It checks whether required sections of a Technical File are present and adequately addressed against published MDR 2017/745 requirements.

Medarro does not provide regulatory advice. It does not replace the judgement of a qualified regulatory affairs professional. It does not guarantee that a Technical File prepared with its assistance will be accepted by a Notified Body. The consultant remains the qualified expert.