April 24, 2023 “Declaration of Conformity” vs. “Certification of Conformity” There are different kinds of declarations and certifications germane to the medical devices sector. And there is a proper distinction to be made between “declaration” and “certification”. I give my further interpretations about that herein. Ultimately, the precise context of each given scenario […]
<h1 class="entry-title">Category: EU MDR</h1>
Declarations of Conformity: U.S. FDA vs. Europe
April 20, 2023 Declarations of Conformity: U.S. FDA vs. Europe I received a question wondering whether the U.S. FDA mandates Declarations of Conformity (DoC) in the way Europe does, and whether U.S. and EU DoC can be combined into a single document. In short, no, the US FDA doesn’t, as a general rule, […]
EU MDR/IVDR Annex IX Full QMS vs. Annex XI Production Quality Assurance
April 20, 2023 EU MDR/IVDR Annex IX Full QMS vs. Annex XI Production Quality Assurance The assessment of the full QMS via Annex IX includes (among other things) the procedures and techniques for monitoring, verifying, validating and controlling the design of the devices and the corresponding documentation as well as the data and records […]
EU MDR Accessories: Identification in the IFU
April 14, 2023 EU MDR Accessories: Identification in the IFU In general, for any class of EU MDR device, but especially for a class III device, the IFU must identify any accessories. Specifically, GSPR 23.4(f) requires (among other things) that, where applicable, the IFU shall contain information allowing the healthcare professional to select the […]
EU MDR Device “Lifetime” vs. “Shelf-life”
April 13, 2023 EU MDR Device “Lifetime” vs. “Shelf-life” Distinguishing between “lifetime” vs. “shelf-life” is important to realizing proper EU MDR compliance. For example, regardless of device class, implantable device lifetime needs to be addressed in the information supplied to the patient [except for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, […]
EU MDR Basic UDI-DI “essential design and manufacturing characteristics”
April 7, 2023 EU MDR Basic UDI-DI “essential design and manufacturing characteristics” According to the MDCG (2018-1), the Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with same intended purpose, risk class and […]
eIFU MDD & EU MDR Notified Body is Required (as applicable)
April 6, 2023 eIFU MDD & EU MDR Notified Body is Required (as applicable) Both Regulation (EU) 207/2012 (the eIFU regulation for the MDD) and Regulation (EU) 2021/2226 (the eIFU regulation for the EU MDR) require that conformity with those regulations be reviewed by a European notified body where applicable (i.e., for those device […]
Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 2
April 4, 2023 Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 2 Carrying on from the first part of this topic from a couple days ago: Indeed, it is wise to stick with longstanding principles and corresponding normative requirements for medical device QMS documentation. And it’s essential to […]
EU MDR Article 22 Statement vs. Article 19 Declaration
April 3, 2023 EU MDR Article 22 Statement vs. Article 19 Declaration Because an EU MDR Article 22 system or procedure pack Statement of Compatibility (SoC) has a different legislative purpose than the Article 19 Declarations of Conformity (DoC) for the components inside the system or procedure pack, then the SoC and DoC need […]
Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 1
April 3, 2023 Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 1 The MDR/IVDR PMS procedures and blank templates for the PMS Plan should be Tier 2 generic quality management system (QMS) documents (i.e., procedures), while the actual PMS Plan should instead be a device-specific Tier 4 QMS […]