Between Benefit and Burden: How much regulation still makes sense?
Regulations, guidance documents, standards, annexes, specifications…What was once intended as a helpful framework now feels to many manufacturers like an overengineered system full of rules, redundancies, and well(?)‑intentioned details. So what is truly necessary – and what could (finally) go?
Our diagnosis:
The idea behind regulation makes sense.
But implementation is often unnecessarily complex.
And: Risk-based clarity and pragmatism are sorely lacking.
Need examples?
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MDCG guidance documents: theoretically non-binding, practically unavoidable
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Excessive requirements for low-risk products
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National databases in addition to EUDAMED – yes, still
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And technical documentation that still refers to product types invented over a century ago
The result:
More effort, higher costs, less room for innovation – especially for small and mid-sized manufacturers.
But it doesn’t have to be that way:
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with digitalized regulatory processes
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with risk-based requirements and assessments
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and with a one-audit approach and real harmonization across authorities and notified bodies
Metecon’s take:
We stand for safety, traceability, and structured processes – but against pointless bureaucracy.
We advocate for efficient, digital, and human-centered regulation, so you can focus on what really matters: safe and effective products.
Want to talk about it?
👉 Book a meeting with Marco Scicolone, Metecon Switzerland
💬 Send us a message
