MDR and miniature dollhouses are much more similar than you might think. Almost frighteningly so.
A few weeks ago, my husband took me to a local dollhouse museum for date night.
This place was amazing, and the houses were all magical and filled with such detail that I could have sat in front of each one for hours and still not see everything.
I was so inspired that I bought a kit to make a small one. I thought it would make a good winter project and provide a creative outlet completely different from my day job – HA!
The darn kit has been a disaster so far, and much more like MDR than I care to admit. Here’s why:
It came with an 18-page instruction book, filled with more than 15 teeny, tiny images per page.
None of the pieces were properly numbered, making the instructions all but useless.
The font was very small, and the instructions had obviously been translated from Chinese into English, and A LOT got lost in translation.
The pieces in the kit looked nothing like the images in the instruction book.
The glue in the kit was not properly sealed and had dried into a solid glomp of adhesive that was of no use to me.
In desperation, I reached out to a friend for help, someone who has successfully converted these incomprehensible kits into beautiful, finished dollhouses and window boxes.
She told me I needed more tools than the kit provided in order to create the miniature furniture and accessories.
She told me I needed to purchase additional tools as well, and that there was a separate painting guide that I needed to find.
She also told me if the instructions say THAT it actually means THIS.
After a lot of frustration, more than a few curse words and a whole lotta tequila, I finally managed to complete a table. One small table.
The project is a lot less fun that I originally anticipated, but now I’m on a mission to complete it, no matter what.
Great story, Michelle, but how, exactly, are MDR and miniature dollhouses alike?
- Both have lengthy, very detailed instructions (MDR itself has 174 pages, plus 123 articles and 17 annexes).
- Both require additional guidance not included in the original documents (think of all those MDCG documents related to MDR that the EC has released in the past five years).
- Both require use of new tools not part of the original kit (think EUDAMED).
- Both suffer from inaccurate translation from the original language.
- Both require help from someone with more experience who can help you interpret the instructions and tell you what else you need to effectively and correctly complete the project.
Don’t let your MDR certification end up like my dollhouse attempt – a mess of pieces and instructions and tools and despair in a pile on your dining room table.
My team and I have helped many manufacturers find their way through the complex regulation that is MDR, and we can help you too.
Here’s another MDR post you might like: https://leanraqa.com/post-brexit-medical-device-legislation/
You can find more delicious MDR content on my YouTube channel: https://leanraqa.com/videos