What changed when 21 CFR 820 became the QMSR
How 21 CFR part 820 became the Quality Management System Regulation, which sections were removed or reserved, and where each requirement now sits.
Tag: medical-devices
18 posts
What an EU medical device submission contains
What a manufacturer files under Regulation (EU) 2017/745: Annex II and III technical documentation, the route by class and how notified bodies review it.
EU quality system requirements for medical devices
How Regulation (EU) 2017/745 requires manufacturers to run a quality management system, from design through surveillance, and who must oversee it.
What an FDA medical device submission contains
What goes into a 510(k), De Novo, PMA or HDE submission to FDA, with format rules and review timeframes.
EU post-market obligations for medical devices
How Regulation (EU) 2017/745 governs post-market surveillance, PSURs, vigilance reporting deadlines and field safety corrective actions for medical devices.
FDA quality system requirements for medical devices
How 21 CFR Part 820 applies the QMSR to device manufacturers, which devices need design and development controls and how combination products are treated.
EU routes to market for medical devices
How device class under Regulation (EU) 2017/745 sets the conformity assessment route, with the Annex IX, X and XI procedures and transitional deadlines.
FDA post-market obligations for medical devices
How 21 CFR Parts 803, 806 and 822 govern adverse event reporting, corrections and removals and ordered postmarket surveillance for US devices.
EU labeling rules for medical devices
How Regulation (EU) 2017/745 governs device claims, label particulars, sterile packaging text and the content of instructions for use.
FDA labeling rules for medical devices
How 21 CFR Parts 801 and 809 govern device claims and label content, from UDI and prescription statements to IVD package inserts.
What evidence the EU requires for medical devices
How Regulation (EU) 2017/745 sets the clinical evidence for a CE marked device, covering clinical evaluation, investigations, equivalence and PMCF.
What evidence FDA requires for medical devices
What must be proven under each FDA device marketing route and the kinds of study that satisfy 21 CFR parts 807, 814 and 860.
When a medical device trial in China needs approval and when a filing
Which medical device trials in China need approval from the national regulator, which need only a filing, and what each route requires.
EU rules for clinical studies of medical devices
How Regulation (EU) 2017/745 governs clinical investigations of medical devices, which studies it covers and when authorisation or notification is needed.
FDA rules for clinical studies of medical devices
How 21 CFR parts 812, 50 and 56 govern clinical investigations of medical devices, including when an IDE application must be submitted to FDA.
How the EU classifies medical devices
How Annex VIII of Regulation (EU) 2017/745 assigns medical devices to class I, IIa, IIb or III, and the rules that decide which class applies.
Which FDA route a device qualifies for, 510(k), De Novo or PMA
How FDA premarket routes divide between 510(k), De Novo and PMA, with the criteria, contents and review timeframes set by 21 CFR parts 807 and 814.
How FDA classifies medical devices
How FDA assigns devices to class I, II or III under 21 CFR Part 860, covering classification regulations, De Novo requests and 510(k) exemptions.