IVDR Transition Series – Episode 2
With only 10 months until the IVDR 2017/746 comes into effect, it is vitally important to work efficiently to transition both your Quality Management System (QMS) and the devices you manufacture, to the new regulatory requirements. A scattergun approach could mean that key elements will be overlooked, resulting in potential non-compliance, so I highly recommend that, before embarking on your IVDR compliance journey, you and your colleagues prepare a water-tight transition plan, which covers every section of the regulation comprehensively.
Whether you call it a Quality Plan or Quality & Regulatory Strategy, your plan’s critical purpose is to prepare a road map, which defines the tasks, milestones and allocation of resource necessary to ensure that you reach the IVDR deadline properly prepared and fully compliant.
Apart from setting out a pathway for your team to follow, when reviewing your QMS and individual devices, it’s our understanding that it also helps when your application is reviewed by your Notified Body, as most will expect you to have a plan in place.
So why is having a plan necessary?
- Increases efficiency:
Planning makes optimum utilisation of all resources available to you. It helps to reduce wastage, avoids duplication and gives the highest level of activity at the lowest cost; increasing the overall efficiency of the transition.
- Reduces business-related risks:
Planning helps to consider and plot potential business-related risks. This gives you an opportunity to avoid or manage such risks and prepare for future uncertainties in advance. This actually reduces the likelihood of those business risks becoming a reality or means that you are better equipped if they do.
How to approach it:
There are a variety of ways to tackle your IVDR Transition Plan. But the following key aspects all need to be considered:
Definition of the Project
This introduces the subject matter to both key stakeholders and reviewers. It provides an outline of the task to be undertaken by your organisation and can include details of the purpose, scope, background and objectives of the project.
The amount of work necessary for your organisation is heavily dependent on the classification of your devices or device families. The risk profile of any device will ultimately dictate the number of tasks and subtasks to be completed. So getting these right at the start will save time and money. Annex VIII of the IVDR is the key tool to use here, since it contains the classification rules for all IVD devices. Its important to note that, if there is any uncertainty with your own conclusions on classification, you can always ask your notified body for clarification.
IVDR Conformity Assessment Route
Again – a device’s classification will also determine which conformity assessment route your organisation needs to follow, as laid out in either Annex IX, X or XI of the IVDR. It is highly recommended that you discuss this with your notified body as soon as possible, if you are in any way unsure.
Having completed a number of IVDR transition projects already, I cannot stress enough how crucial this step is in identifying deficiencies in current documentation, data and processes. Once your device has been classified, a Gap Assessment will check whether your QMS stands up to the regulatory requirements of the IVDR AND confirm whether your devices meet the new Technical Documentation requirements, in particular the area of clinical evidence. Used well, this comprehensive tool can help you identify strengths and weakness, help you prioritise remediation work and drive allocation of time and resource required to tick these off. Gap Assessments are very high in importance for IVDR Transition and I intend to talk about these and how to use them effectively, in more detail in my next IVDR Blog in August,
IVDR Regulatory Pathway & Requirements
The output of the gap assessment will add value to this part of the plan, which may document aspects such as the Person Responsible for Regulatory Compliance (PRRC), the appointment of an Authorised Representative (AR), implementation of the QMS, establishing requirements to meet General Safety and Performance Requirements (GSPR) and identifying required Technical Documentation.
I’ve given you the key areas to focus on, but no one knows your device like you do and its time to get cracking. Planning your IVDR strategy is an essential process to document, before commencing your Transition project. Ensuring that you have an exhaustive list of tasks necessary to migrate to IVDR, understanding exactly which resource and how much of it is needed to complete the process – and making it available without interrupting your day to day business, can only be achieved by dedicating expert resource to create that Plan..
How can IMed help?
IMed has IVD experts on hand, who are well-versed with IVDR and completing critical Gap Assessments to set you on the right track. Just get in contact (details below).
Look out for Stephen’s 3rd IVDR Transition Blog next month, for more on those essential Gap Assessments!
IMed QA & IVDR Consultant