Without going into depth on any particular comment here, here is an excerpt from the EMA:
"Medical devices are products or equipment intended generally for a medical use and are regulated at Member State level. The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In-Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for the European Medicines Agency (EMA) and national competent authorities in the assessment of certain categories of medical device.
Medical devices in the EU have to undergo a conformity assessment to demonstrate that they meet legal requirements to
ensure they are safe and perform as intended. EU Member States can designate
accredited notified bodies to conduct conformity assessments.
The
conformity assessment usually involves an audit of the manufacturer’s quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device.
Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment."
Source:
https://www.ema.europa.eu/en/human-regulatory/overview/medical-devicesWhether this is as rigorous as the FDA I do not know, but having lived in Germany for 20 years I have no doubts that German standards of quality assurance are as good as anyones, in particular in medicine where entry requirements are extremely high. By that I mean top 1% of your graduation (Numerus Clausus) class and 13 years of studies before you can even call yourself a specialised doctor (i.e. Facharzt).
It would be inconceivable to me that someone makes it through this system, earns a professor title and works as one of the most senior surgeons in Munich to then produce a nail that is of low quality and sort of goes under the radar of the German or European quality assurance agencies.
I am of course not an expert in legal matters, but if safety and regulatory conformity are a concern, then I feel confident that Germany is one of the best, if not the best, place to go to.