Regulatory watch: know what changes for your products, not what changes in general.
An MDR, IVDR, MDCG and standards watch filtered to your portfolio, with product-by-product impact analysis and a monthly summary.
Initial scoping is free, with no commitment. Monthly subscription, no long-term commitment.
What you get
- Qualified alerts
- Impact analysis on your products
- Monthly summary
Good to know
- Goes further than the platform's free watch: every alert is analysed for your portfolio
Ideal if: your portfolio spans several standards and nobody has time to sort out what really applies to you in each new publication.
The problem is not getting the information
Regulatory information is public and plentiful. EU legislation, MDCG guidance, harmonised standards, opinions from competent authorities: it is all accessible, and several free newsletters flag it for you perfectly well.
The problem starts afterwards. A new MDCG guidance document comes out, it runs to forty pages, and the only question that matters to you is: does this change anything for my products?
Answering it means cross-checking the text against your portfolio, your classes, your claims and your existing files. That is the work that never gets done, for lack of time, and it is the work that has value.
What you receive
Qualified alerts
Filtered to your actual portfolio. What does not concern you never reaches you, which avoids the opposite effect of overload: no longer reading anything.
An impact analysis for your products
For each change we retain, what it means in practice: which files are affected, which sections need reworking, which deadline applies.
A monthly summary
A single document, ready to present at management review, that recaps what has changed and what remains to be addressed. It is also evidence of regulatory watch, which auditors expect to see.
What this service adds to the free regulatory watch
The My Audit Corner platform already offers a free regulatory watch, which continuously monitors EU regulations, ISO and IEC standards and official guidelines. It is useful and will remain so.
Its limit is that it tells you what is published, without judging your particular situation.
The custom regulatory watch adds exactly that: each alert is analysed against your portfolio, your classes and your files, by someone who knows them. You no longer receive information to process, but a decision to make.
Discover the platform's free regulatory watchFrequently asked questions
The EU MDR and IVDR regulations and their implementing acts, MDCG guidance, harmonised standards and common specifications, as well as publications from competent authorities. The exact scope is set during scoping according to your markets.
The MDR does not require a "regulatory watch" by that name, but it does require compliance to be maintained over time, which means knowing about applicable changes. In audits, the absence of any documented regulatory watch process is regularly raised as a weakness of the system.
A newsletter tells you what has been published. The custom regulatory watch tells you what it changes for your devices, naming the files concerned and the sections to rework. It is the difference between information and decision.
The impact analysis identifies the affected files and the scale of the work. If the project is more than your teams can absorb, it calls for a dedicated service, typically an impact gap analysis or a technical file rework. We tell you so rather than letting it pile up in the monthly summaries.
Yes, and the combination is common. Keeping track of regulatory obligations is part of the PRRC's role; the custom regulatory watch subscription extends it to your entire portfolio, with a formal summary.
Nobody has time to sort out what concerns you?
Tell us about your portfolio and your markets. Scoping is free.