UK Medical Device Regulations

UK Medical Device Regulations, especially with respect to BREXIT issues.
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Clinical Study Design for IVD Self-Test (lay user) Products
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260
TCmeddev
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dgrainger
Informational MHRA - Extension of CE certificates
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265
dgrainger
dgrainger
dgrainger
Informational MHRA Guidance: Crafting an intended purpose in the context of Software as a Medical Device (SaMD)
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0
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456
dgrainger
dgrainger
BusyBee
IVD relabeling
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2
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390
dgrainger
dgrainger
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How to handle registration of apps
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1
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258
Billy Milly
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MDD CE Marking & UKCA Marking
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2
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364
Raisin picker
Raisin picker
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Gibraltar refurbished medical devices
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1
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361
Miner
Miner
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RAC Certification Study group
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0
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308
pavanamg
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Brexit Combination Product Regulatory pathway for UK (MHRA).
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1
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648
Simona F.
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dgrainger
Informational MHRA Medical Devices Regulation Webinar - 24 January 2023, 10:00-11:30 GMT
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436
dgrainger
dgrainger
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Declaration of Conformity for UKCA
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14
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2K
Philip B
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Newbie22
UPDATE UKCA; UK 12 month extension (Future regulation of medical devices - extension of standstil period)
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4
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680
Mazza
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Technical documentation for UKCA
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4
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1K
Ronen E
Ronen E
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UKCA for devices already placed on the market
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16
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2K
dgrainger
dgrainger
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UK QMS Requirements
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2
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606
dgrainger
dgrainger
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