January 25, 2024 EU MDR Virtual Importers While I can see potential benefits of voluntarily creating an importer (along with the additional regulatory burden) to add a layer of compliance checks and balances, I strongly advise against the basis being an assertion that end users need regulation because they have, as one person […]
<h1 class="entry-title">Category: CE Mark</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 […]
Design & Development Includes Regulatory Submissions
April 18, 2023 Design & Development Includes Regulatory Submissions Premarket regulatory submissions [e.g., U.S. FDA 510(k) / PMA; European Technical Documentation Submissions, Canadian Device Licensing, Australian ARTG registration, etc.] need to be driven by, and documented in association with, the design and development process and documentation. For example, both the FDA (via the QS […]
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 […]
EU MDR Transitional Extension Regulation (EU) 2023/607 and Expired MDD/AIMDD Certificates
March 27, 2023 EU MDR Transitional Extension Regulation (EU) 2023/607 and Previously-Expired MDD/AIMDD Certificates Even if an MDD/AIMDD certificate from 25 May 2017 expired before Regulation (EU) 2023/607’s March 15 (20?), 2023 entry into force, and as long as it wasn’t “withdrawn” for cause (e.g., see EU MDR Annex IX.3.7), then placing on the […]