It is about time to start YOUR MDR/IVDR project. Even though the whole world is lamenting about the new Medical Device Regulation (MDR) and In-vitro Diagnostic Medical Device Regulation (IVDR), it will not help. The deadline will (most likely) not be moved, and being late will exclude your products from the whole EU market. Should the Member States and the Parliament indeed come to the conclusion that moving the deadline is a sensible thing to do, it may not apply for all products, and it would not hurt your business to be the frontrunner setting the stage for selling your products with being MDR compliant.
In this issue of News and Views, we will focus on the MDR, but it applies similarly to IVD products, with different timelines.
The timeline in brief:
The new regulation is enforced since 2017, and in some instances can be fully applied.
The new regulation must be applied in May 2020.
The MDD will cease to exist.
Now we have to distinguish between two product groups.
Products which are associated with a notified body (NB) and certified with a NB. These are products of risk class IIa, IIb, III, and products of risk class I which are sterile or have a measuring function.
Risk class I products.
Products which are certified with a NB:
The MDR provides that those products may be ‘placed on the market’ until 2024 with a valid MDD certificate and certain MDR provisions.
Extensions of MDD certificates are still issued by NB. Should your certificate expire somewhere around 2022, an extension may be indicated. The extension, or for that matter any certificate according to the MDD, must be issued by the NB by May 2020.
The NB will not be able to issue a new certificate after the application date. The products are covered by those certificates as long there is no change of intended use or a significant design change.
For class I products:
They must comply with the regulation by May 2020.
MDSS is concerned with the implementation - the lack of resources in the industry and not just with the notified bodies, and other very specific implementing aspects. However, we are particularly worried in regards to:
Products of risk class I.
Products, which were previously not covered by the MDD, but now need to be certified due to the extended scope of the MDR.
Products of previously class I, which now need to be certified by May 2020. Those are:
a. Risk class I reusable instruments.
b. A lot of software due to the new software classification rule.
c... any other product being class I under the MDD and now of a higher risk class (possibly substances and products including nanomaterial).
Those products under point 2 and 3 need to be certified and will face the NB shortage. Our advice is: GET IN CONTACT WITH A NB OR WITH YOUR NB TO DISCUSS THE MDR CERTIFICATION PLAN…NOW!
A great concern for us are the manufacturers who only have risk class I products in their portfolio. They have not been exposed to a mandatory quality system or any third party review. In addition, in their home countries, not much control was applied either (i.e. in the USA they may also be FDA exempt). The reason is simply that they do not pose a lot of risk.
The particular concern is that those risk class I products may not be able to comply on time, due to the extensive technical file and quality system requirements that apply for these risk class I products just as they apply for the highest risk class products. Article 10 outlines those requirements, and that article does not distinguish between risk classes!!! Act now!
The lowest risk class products need to fully comply earlier than the highest risk class products! ‘Great job, lawmaker!’ - a patient may say when he has to wait for his low risk class product due to administrative delay.