Medical devices Flashcards
What marking is needed for medical devices in Northern Ireland (NI)? 🇬🇧🍀
🟩 Must have both UKCA ✅ and CE ✅ markings.
What markings are accepted for medical devices in Great Britain (GB)? 🇬🇧
✅ UKCA or ✅ CE — both are accepted indefinitely for flexibility! 🔄
What marking is required for medical devices in the EU? 🇪🇺
🟦 CE mark only!
What defines a custom-made medical device in the UK? 🛠️
👩⚕️ Made under written prescription
👤 For use by one specific patient
🚫 Not mass-produced or adapted items
What defines a medical device in NI? 📃
🧪 Instruments/software for:
Diagnosis 🧠
Treatment 💉
Monitoring 📊
Prevention 🛡️
Compensation for injury ♿
What are the classes of medical appliances? ⚙️
1️⃣ Class I – Low risk
2️⃣ Class IIa – Medium risk (e.g. dental devices) 🦷
3️⃣ Class IIb – Medium-High risk
4️⃣ Class III – High risk 🚨
Can Class I and IIa devices be given without written prescription? 📄❌
Yes, if safe to use without prescription 👍
Give an example of a dental device. 🦷
Gold veneer crown 👑
Which dental procedures are NOT classed as medical devices? ❌🦷
Intraoral fillings ✨
Temporary fillings 🕒
Chairside temp crowns 👑
Splints post-trauma 🦷💥
What % of adults had artificial crowns in 2009? 📊
What % of adults had implants? 🔩
37% 👑
Just 1%! 😮
What can dental nurses do with extra training? 👩🔬
🧪 Pour/trim models
🛠️ Make trays & record rims
🦷 Repair acrylic parts
🥊 Make mouth guards
What can orthodontic therapists do? 🦷🪛
📋 Work under dentist’s prescription
🛠️ Insert/removable appliances
🧰 Fit retainers, headgear
🧼 Repair acrylic parts with training
What extra can dental hygienists/therapists do? 🪥
👑 Recement temp crowns
✨ Tooth whitening
😬 Bleaching tray insertion
What can clinical dental technicians (CDT) do? 🦷🧑🔧
✅ Prescribe & fit dentures
🥊 Sports guards
😴 Anti-snore devices
👑 Recement crowns
🧰 Fit attachments chairside
What’s the dentist’s role? 🦷👨⚕️
🧾 Prescribe all appliances
🪡 Provide prostheses (bridges/dentures)
🪄 Cosmetic injectables (if trained)
🛡️ Ensure MDR compliance
What must a statement of manufacture include? 📝
🏷️ Manufacturer’s name & address
🔍 Device identification info
🦷 Type of device (e.g. chrome denture base)
✅ Conforms to UK MDR 2002
👨⚕️ Dentist’s name & practice
Is it a legal requirement to give patients the statement?
Yes! 📑
🙋♂️ Patient can request it
📝 Record if they accept/refuse
🚫 Criminal offence if not followed!
Who regulates dental labs? 🧪🏛️
🏛️ MHRA oversees lab registration
🧪 Labs must register to work legally
⚠️ Dentist responsible for devices made by non-UK labs!
Who is ultimately responsible for the device quality? 🔍
🧑⚕️ The dentist is!
✅ Ensure lab registration
📜 Statement provided
🛡️ MDR compliance
