Alison Dennis, head of life sciences at Taylor Wessing spoke to Med-Tech Innovation News about the difference between IVDMDD and IVDR.
What are the mechanics of the new regulation?
The IVDR will be fully applicable in the EU from 26 May 2022.
The basic mechanics of the regulation are the same as for the Directive: both follow the New Approach. IVDs are now split into classes (A to D), as opposed to lists, and the highest classes will require notified body certification. The assessment for all IVDs will be against 20 general safety and performance requirements (GSPRs), with the need to balance risks against benefits in the safety and effectiveness of the IVD. The manufacturer will draw up detailed technical documentation against those GSPRs. This will be reviewed, where applicable, by the notified body. The technical documentation will also need to detail the post market surveillance system (PMS) that the manufacturer will have in place to continually monitor and assess the safety and effectiveness of the IVD in actual use.
The Regulation requires that all actors in the supply chain (known as economic operators, EOs) take a role in ensuring that devices are properly regulated and are safe. Because each EO requires information from further up the supply chain and is required to provide information to other EOs, this means that a network of agreements must be put in place.
Where are IVD firms going to have to change practices?
The most major change in regulatory practices for IVDs is the requirement for notified body certification. Under the Directive only 10-15% of IVDs require notified body certification, whereas under the Regulation it is estimated that this could be as many as 85%. IVD firms must learn how to meet the requirements of notified bodies and should prepare for regulatory activities to delay market entry for new IVDs compared to current timelines.
The second biggest change is the requirement for more, and more rigorous performance evaluation data. Data will not only be required but will then be scrutinised by a notified body for the majority of IVDs. Companies will need to generate data if they do not currently hold or cannot otherwise obtain adequate data supporting the safety and effectiveness of their IVDs. This data-gathering will then need to continue through structured and pro-active engagement in post marketing surveillance (PMS) activities.
Manufacturers based outside the EU will require an importer based in the EU. Because the importer’s name and contact details must accompany the IVD for most IVDs it is not practical to have multiple distributors each acting as importer. Manufacturers from outside the EU are having to establish an EU entity that acts to “place the devices on the market” in the EU.
Are IVD firms prepared for regulatory changes?
Notified bodies are currently reporting low up-take in applications for certifications under IVDR. This indicates that IVD firms are not yet ready for the regulatory changes.
Translating our experiences with MDR, it is likely that a substantial number of SME IVDR manufacturers have not progressed far with preparing for the extensive regulatory changes represented by IVDR.
Although there is a transition period, this will not apply to IVDs which do not require a notified body under IVDMDD but will do so under IVDR, which is the majority of IVDs. It is therefore imperative that IVD manufacturers prepare for and submit applications to a notified body as soon as possible.
What do IVD manufacturers need to consider ahead of the deadline?
- What their new IVD classifications will be
- Whether notified body certification is required
- Whether they have adequate data to answer fully the GSPR requirements
- How to gather additional data needed via a performance evaluation to support their IVD application and to do in sufficient time to make an application to a notified body to obtain a certificate before 26 May 2022
- Working on designing their technical documentation
- A new PMS system to meet the requirements of the IVDR by 26 May 2022
- Setting up agreements with EOs to include obligations on information flows up and down the supply chain for regulatory purposes.
What is the effect on firms in the UK and Ireland?
The IVDR will apply in both the Republic of Ireland and in Northern Ireland.
If IVD manufacturers have UK notified body certificates under IVDMDD that these are transferred to a notified body in the EU and that any AR is also transferred into the EU, or alternatively Northern Ireland.