Department-Specific Guides
Tailored MDR/IVDR guidance for different clinical areas
Pharmacy Department
Medical devices handled alongside medicines
Key Device Categories
- • Drug delivery systems (infusion pumps, syringes)
- • Drug-device combinations
- • Prefilled syringes and cartridges
- • Nebulisers and inhalers
- • Insulin pens
- • Compounding equipment
Pharmacy-Specific Considerations
Drug-Device Combinations
Under MDR, if the device is integral, the combination follows the medicinal product route but device component must meet relevant MDR requirements. CE marking may be required for the device component.
Programmable Infusion Pumps
Typically Class IIb. Ensure drug library compatibility. Software updates may change classification - verify post-update.
Compounding Under Article 5(5)
Hospital pharmacy producing custom preparations must meet in-house exemption conditions if using non-CE marked equipment.
Critical Action Items
- • Maintain separate inventory tracking for devices vs medicines
- • Include UDI in dispensing records for device components
- • Review infusion pump software versions during procurement
- • Ensure FSCA response process covers pharmacy-managed devices
Radiology & Medical Imaging
High-risk diagnostic and therapeutic equipment
Key Device Categories
- • X-ray equipment (radiography, fluoroscopy, CT)
- • MRI systems
- • Ultrasound equipment
- • Nuclear medicine (gamma cameras, PET)
- • AI-based diagnostic software
- • PACS and image analysis systems
- • Contrast injectors
Radiology-Specific Considerations
AI Diagnostic Software (Rule 11)
AI software providing diagnosis information is typically Class IIa or IIb. If decisions could cause death (e.g., cancer screening), Class III applies. Verify classification before procurement.
Cybersecurity for Connected Systems
PACS and networked imaging systems must meet MDR cybersecurity requirements. Include cybersecurity updates in maintenance contracts.
Radiation Emitting Devices
Additional national radiation protection requirements apply alongside MDR. Coordinate with Medical Physics.
Critical Action Items
- • Document AI software clinical validation before deployment
- • Track all software version updates with regulatory impact assessment
- • Include cybersecurity review in annual equipment reviews
- • Maintain evidence of user training for all imaging modalities
Laboratory & Pathology
IVD devices for diagnostic testing
Key Device Categories (IVDR Focus)
- • Clinical chemistry analysers
- • Haematology analysers
- • Microbiology systems
- • Blood typing/screening reagents
- • Infectious disease assays
- • Genetic testing/companion diagnostics
- • Laboratory Developed Tests (LDTs)
Laboratory-Specific Considerations
IVDR Classification Changes
Many IVDs previously self-certified now require Notified Body assessment. Blood screening (Class D) and infectious disease assays (Class C/D) are most affected.
Laboratory Developed Tests (LDTs)
LDTs must now meet IVDR requirements unless qualifying for Article 5(5) health institution exemption. This requires QMS implementation.
Companion Diagnostics
Class C or D - critical for patient treatment decisions. Ensure coordinated procurement with pharmacy/oncology.
Class A
General reagents, specimen containers
Class B
Clinical chemistry, self-testing (low risk)
Class C
Companion diagnostics, high-risk infectious
Class D
Blood screening, HIV, Hepatitis
Critical Action Items
- • Audit LDT portfolio against IVDR requirements - deadline passed for most
- • Verify reagent CE marking status during replenishment orders
- • Document performance evaluation for any in-house validated methods
- • Track lot-to-lot variation - required for trend reporting
Cardiology
High-risk implantables and monitoring equipment
Key Device Categories
- • Pacemakers and ICDs (Class III)
- • Coronary stents (Class III)
- • Heart valves (Class III)
- • Cardiac monitors and ECG systems
- • Defibrillators (AEDs and manual)
- • Cardiac catheterisation equipment
- • Remote patient monitoring systems
Cardiology-Specific Considerations
Implant Traceability
MDR requires full traceability for implants. Patient implant cards must be issued. Hospital must be able to identify all patients with specific implant lots.
FSCA for Active Implants
Pacemaker/ICD recalls require rapid patient identification and clinical review. Maintain robust patient-device linkage systems.
Remote Monitoring Software
Cardiac remote monitoring platforms are medical devices under Rule 11. Verify CE marking and data security compliance.
Critical Action Items
- • Maintain implant registry linked to patient records
- • Ensure patient implant cards are issued at discharge
- • Subscribe to manufacturer FSCA notifications for all implant ranges
- • Annual review of remote monitoring platform CE status
Operating Theatre & Surgical
Surgical devices, instruments, and reprocessing
Key Device Categories
- • Surgical instruments and retractors
- • Electrosurgical units
- • Surgical robots
- • Anaesthesia machines
- • Patient monitoring systems
- • Sterilisation equipment
- • Single-use surgical devices
Theatre-Specific Considerations
Reprocessing of Single-Use Devices
MDR Article 17 allows Member States to permit SUD reprocessing under strict conditions. If your facility reprocesses SUDs, ensure compliance with national rules.
Surgical Robots
Typically Class IIb. Complex systems requiring comprehensive training documentation. Software updates may require re-validation.
Instrument Tracking
UDI-based tracking of reusable instruments supports both traceability and sterilisation cycle documentation.
Critical Action Items
- • Verify SUD reprocessing is permitted under national legislation
- • Maintain instrument tracking through decontamination cycles
- • Document surgical robot training for all operating surgeons
- • Include consumables in device register where Class IIb or higher
Community Healthcare & Primary Care
Point-of-care devices and home care equipment
Key Device Categories
- • Blood glucose monitors
- • Blood pressure monitors
- • Pulse oximeters
- • Point-of-care testing devices (INR, HbA1c)
- • Wound care products
- • Home oxygen equipment
- • Mobility aids
Community-Specific Considerations
Patient Self-Testing Devices
IVDs intended for self-testing are generally Class C under IVDR. Ensure patient information materials are CE marked as part of the device.
Loaned Equipment
Devices loaned to patients remain your responsibility. Track location, maintenance status, and ensure patient training is documented.
Distributed Stock
Community sites with device stock must be included in FSCA processes. Maintain current inventory lists at all locations.
Critical Action Items
- • Track all loaned devices with patient assignment records
- • Include community sites in FSCA communication cascade
- • Verify point-of-care IVD CE status - many transitioning to IVDR
- • Document patient training for self-monitoring devices