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 […]
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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25 May 2017 expired before Regulation (EU) 2023/607’s March 15 (20?), 2023 entry into force, and as long as it wasn’t “withdrawn” for cause (e.g., see EU MDR Annex IX.3.7), then placing on the […]
EU MDR: Who Must Hold the Annex XI Part A Certificate?
March 24, 2023 EU MDR: Who Must Hold the Annex XI Part A Certificate? In addition to a production-focused quality management system certificate(s) (e.g., EU Quality Assurance Certificate or EU Product Verification Certificate), the EU MDR Annex XI Part A conformity assessment route requires the “manufacturer“, depending on device class, to also hold an: […]
Regulatory Misconduct Allegations
March 23, 2023 Regulatory Misconduct Allegations Making unsubstantiated claims about one’s device, promoting off-label uses, and selling medical devices with uncleared/unapproved features are examples of what the U.S. FDA calls “regulatory misconduct”. Specifically, regulatory misconduct is when a medical device manufacturer or other individuals marketing medical devices are doing so in a manner that […]
EU MDR Classification of Accessories – “In Their Own Right”
March 22, 2023 EU MDR Classification of Accessories – “In Their Own Right” As noted previously, pursuant to EU MDR Article 1 paragraphs 1 and 4, and particularly EU MDR Annex VIII.3.2, accessories for a medical device shall be classified in their own right separately from the device with which they are used. […]
EU MDR Notified Body Demanding Use of Harmonized Standards
March 21, 2023 EU MDR Notified Body Demanding Use of Harmonized Standards Your notified body seems to be employing a classic infamous misuse of harmonized standards for the MDD and/or EU MDR. I generally advise our clients to respectfully, carefully, and legislatively, push back on such misuse. But without seeing the full details […]
EU MDR Classification of Accessories
March 21, 2023 EU MDR Classification of Accessories Pursuant to EU MDR Article 1 paragraphs 1 and 4, and particularly EU MDR Annex VIII.3.2, accessories for a medical device shall be classified in their own right separately from the device with which they are used.
Can multiple different devices be on a single EU MDD/MDR DoC?
March 21, 2023 Can multiple different devices be on a single EU MDD/MDR DoC? For a Declaration of Conformity (DoC) to a European Directive like 93/42/EEC on medical devices or to a European Regulation such as 2017/745 on medical devices, multiple different devices may indeed be encompassed by a single DOC. The Blue Guide […]