IVDReady webinar series
COMING SOON 26/05/2024 4:07 am
Jun 20, 2023
IVDReady by May 2024 with Platomics

Our kick-off webinar will introduce you to Platomics, our IVDReady Program, our partners, and IVD Assistant, our platform for compliance.

6. Juli 2023
1. Let’s talk strategy

Das erste, was Ihr Labor braucht, ist eine Strategie für die Dokumentation von Workflows, egal ob Sie 50 oder 250 interne Tests haben. In diesem Webinar werden mehrere mögliche Ansätze vorgestellt.

Jul 25, 2023
2. Give it a purpose

The next step is formulating the intended purpose for your in-house tests. From here this webinar will also cover documenting qualification as a medical device and risk classification under IVDR.

Aug 29, 2023
3. Perplexity is the beginning of knowledge

This webinar will outline Platomics’ regulatory knowledge base that supports labs in understanding what exactly the IVDR requires of them.

Oct 12, 2023
4. Gate Opening: Introducing the Workflow Studio

Here we’ll show how our Workflow Studio quickly allows your lab to create compliant workflows by integrating manufacturers’ components plus the required documentation from the manufacturer.

Jan 30, 2024
5. GSPRs are challenging, standards are beautiful

GSPRs are challenging, and therein lies the beauty of established standards: they are state-of-the-art and as such can reliably fulfill the GSPRs. Find out what your lab needs to do and how best to get it done. 

Mar 5, 2024
6. An ounce of validation

We’ll explain how to fulfill both IVDR and ISO 15189 requirements regarding verification and validation, and how there is no “one size fits all” on this issue.

2024
7. The real risk is not managing risk

Labs will need to have a robust risk management process in place to meet the requirements and ensure safety and reliability for patients. This webinar will provide orientation. 

2024
8. Product excellence: Everything, everywhere, all at once

We’ll take you through various aspects of product excellence required by IVDR, from instructions for use to labeling, SOPs and documenting the design and manufacturing of your in-house tests and components.

2024
9. Vigilance: The shield, sword and light

Perhaps the most daunting aspect of the IVDR for labs are the new requirements for clinical use surveillance. We’ll explain what active vigilance throughout the life cycle of your in-house tests means for your lab.

2024
10. IVDReady at last

Our final webinar will offer an outlook on important aspects for remaining IVDR compliant, including what is coming in the final phase of implementation in 2028.

Ireland moves to
support labs
with IVDR

Ireland has taken a rather vigorous
approach to IVDR and is finding
ways to get labs active, too.

The most recent sign of this: The Irish Health Products Regulatory Authority, or HPRA, published a draft guide for Irish health institutions that develop and use in-house-devices and are now soliciting their feedback on the initiative. 

This makes Ireland one of the first countries to directly address labs to clarify national peculiarities alongside IVDR requirements. Given that many labs across the EU are still in the dark about the full set of requirements and how to fulfil them, this effort at transparency and stakeholder involvement stands out.  

From the start of full IVDR implementation on May 26, 2022, Ireland—like most other countries—took immediate steps to motivate labs and manufacturers to act. One day later they passed national regulations outlining the role of HPRA and detailing how offenses will be handled. 

Soon after they sent a clear message by requiring manufacturers, distributors and labs to actively come forward and register their IVD devices with the national authority. 

The newly published HPRA guide aims to go beyond making demands and instead support health institutions and clinical labs in implementing the combined requirements of IVDR plus Ireland’s own specifications. 

Key contents include:  

  • Glossary and definitions: Key terms are defined—starting with in vitro diagnostic medical device and health institution—based on IVDR and MDCG 2023-1 definitions in order to establish a common ground. 
  • Scope and introduction: The guide introduces the IVDR and outlines its scope, emphasizing the requirements for labs in Article 5(5). 
  • Requirements for in-house IVDs: Article 5(5) requirements are detailed, including the General Safety and Performance Requirements plus those for declaration and documentation and lab quality management systems. 
  • Notification and reporting: This section details Ireland’s strict surveillance of IVDs. All labs with IH-IVDs must notify the HPRA about their activities. All incidents must be recorded, and all serious incidents reported to HPRA. 
  • Differentiating requirements: The guide distinguishes between organizational and IVD-specific requirements, providing clarity on which requirements apply at an organizational level (e.g., QMS aspects) and which are specific to individual IVDs (e.g., performance). 
  • In-house IVD frameworks: In addition to the stand-alone case of an IH-IVD for a very specific purpose, the draft also proposed a strategy for labs that have several IVDs that share parts of a workflow. This method of documenting workflow steps in a modular way is helpful in particular for labs that perform NGS. 
  • General Safety and Performance Requirements checklist: The guide also provides a rather abbreviated checklist to assist labs in complying with the General Safety and Performance Requirements as per IVDR Annex I. 

 

Irish labs may respond to the HPRA by January 26, 2024 using this response template. 

Disclaimer: We have compiled the above information to the best of our knowledge, yet our blog entries do not constitute expert advice and cannot substitute your own examination of the legal situation applicable to you and your organization.