MDIN

Where to get things done in UK medtech: test labs, cleanrooms, CROs and approved bodies

Rob Wakeford — Mon, 09 Nov 2026 11:35:33 +0000

If you’re developing a medical device in the UK, sooner or later you’ll need facilities you don’t have: a microbiology lab, a biocompatibility lab, a steriliser, a cleanroom, perhaps a CRO for a clinical investigation, and eventually an approved body. This post is a working list of the medical device test labs UK developers actually […]

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Do you need ISO 13485 certification to UKCA or CE mark a device?

Rob Wakeford — Mon, 02 Nov 2026 09:46:22 +0000

The short answer is no. There is no device class where the law says you must hold an ISO 13485 certificate before you can UKCA or CE mark, and that surprises a good number of the founders and smaller manufacturers we speak to. The relationship between ISO 13485 and UKCA marking (the CE position is […]

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An ISO 13485 internal audit plan for a small company: a worked example

Rob Wakeford — Thu, 29 Oct 2026 11:13:04 +0000

An ISO 13485 internal audit plan is a documented schedule setting out which parts of your quality management system will be audited, when, against what criteria and by whom, so that over a defined period (normally twelve months) the whole QMS gets looked at. Clause 8.2.4 of the standard asks for audits at planned intervals, […]

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A medical device technical file template: the folder structure we use

Rob Wakeford — Mon, 19 Oct 2026 10:04:00 +0000

If you search for a medical device technical file template you will mostly find tables of contents rather than anything you can actually use, so this post sets out the folder structure we create at the start of every project at MDIN. It follows Annex II and Annex III of the EU MDR and it […]

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The medical device development process: 5 phases explained

Rob Wakeford — Mon, 12 Oct 2026 13:53:25 +0000

When someone gets in touch with a device idea, one of the first things they usually want to know is what the path from idea to a product on the market actually looks like. It’s a fair question, because from the outside the process can seem fairly opaque, and there’s quite a bit of conflicting […]

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MDR/UKCA gap assessment: what it covers and when you need one

Rob Wakeford — Mon, 05 Oct 2026 09:06:55 +0000

If you’ve got a medical device with some history behind it, perhaps a technical file written under the old directives or documentation inherited from a previous consultant, you’ve probably wondered how much of it would stand up against the current requirements. A UKCA gap assessment, or an MDR one (in practice it’s often both at […]

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Class I medical devices in the UK: the self-certification route and why it still needs a full technical file

Rob Wakeford — Mon, 05 Oct 2026 08:29:52 +0000

Class I is the lowest risk class under the UK Medical Devices Regulations 2002, and it covers a surprising amount of ground, from walking aids and wheelchairs through to reusable surgical instruments and quite a bit of standalone software. It is also the only class where you can take a device to the Great Britain […]

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Article 117 for drug-device combination products, explained for developers

Rob Wakeford — Mon, 21 Sep 2026 10:02:03 +0000

If you’re developing an autoinjector, a prefilled pen or an inhaler, most of the regulatory attention (and usually most of the budget) goes on the drug. The device tends to get treated as packaging until fairly late in the programme, and that’s exactly where Article 117 catches people out. It’s the part of the EU […]

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ISO 13485 internal audit: how to prepare

Rob Wakeford — Mon, 14 Sep 2026 09:03:01 +0000

Internal audits are one of those QMS activities that tend to get left until the certification body visit is looming, at which point they get done in a hurry, mostly to generate a record. That’s a missed opportunity, because a well-run internal audit is one of the more useful tools you have for finding problems […]

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Concept feasibility studies for medical devices: what happens in a 1-2 week sprint

Rob Wakeford — Mon, 07 Sep 2026 09:07:49 +0000

Quite a bit of the work we do at MDIN starts with someone who has a device idea, often a clinician or a small company founder, and a very reasonable question: is the idea actually worth pursuing? They don’t need a finished device at that point, and they usually don’t need a big development programme […]

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