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.
Tag: eu
11 posts
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.
The IVDR in-house exemption and what it costs to rely on
How Article 5(5) of the IVDR allows a health institution to make and use its own in vitro diagnostic, and the nine conditions attached.
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.
Working through the IVDR classification rules
How Annex VIII of Regulation (EU) 2017/746 assigns in vitro diagnostics to classes A, B, C and D, and what each class determines.
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.
What one assay has to prove under FDA and under the IVDR
How FDA classification and special controls compare with IVDR performance evaluation in the evidence a single in vitro diagnostic has to generate.
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.
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.
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.
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.