Thank you for the introduction and welcome everybody to today’s webinar. We are going to be talking about combination products, but before I do that, I’d like to give you an overview of the medical device regulations – 2017/745 and in particular, article 117 that specifies the requirements for combination products. I know we do have a lot of medical device regulatory professionals on board, but we also have pharmaceutical regulatory affairs professionals on board here as well. And it’s fair to say that the pharma guys might not be as familiar with what’s happening in the medical device world. I’ll take a minute or two to just give you an overview of the medical device world, and then go into article 117 because it specifically addresses bits of the medicinal product directive, which is very important here.
The medical device regulations are famously abbreviated as the MDR, so I’ll be referring to it as the MDR going forward, but it’s the Medical Device Regulations 2017/745. This was adopted in April 2017 and entered into force on the 25th of May, 2017, by the European commission. This regulation amends 2 or 3 elements. You have the medicinal products directive, the food’s regulation, and you’ve got your cosmetics regulation. The new medical device regulation is amending these 3 directives/regulations. At the same time, it withdraws and replaces two other significant directives. So you’ve got the Active Implantable Medical Device Directive (AIMDD), and then you’ve got the outgoing Medical Device Directive (MDD). So it’s amending, it’s withdrawing, and replacing. That’s an important thing that we need to take here.
Now for the timeline of the MDR – I’ve already mentioned that it was adopted and it came into effect on the 25th of May 2017. However, there was a 3-year transition period. This was from May 2017 to May 2020, called the initial transition period. Now, we all know what happened last year, the entire world experienced a pandemic. So, the European commission acknowledged this, and approached the parliament and said, can we postpone the date of application of the MDR by another year?
And in April 2020, a one year extension was granted, and it was postponed until the 26th of May, 2021.
What are combination products? – Combination products are two products put onto the market – and when I say two products, I’m talking about a medicinal product with a medical device, and these are either integral or non-integral. Now, if it’s non-integral, you could have a combination where two separate products are packaged together, so they are co-packaged or non-integral. A good example could be cough syrup, which is a medicine, and a measuring spoon that comes with it. Now the measuring spoon is your medical device, but the cough syrup itself in the bottle is the medicine. So these would be non-integral, since they are separate, but they’re put into the same box. So that’s a non-integral combination product.
Combination products are a combination of products being put together. They could be co-packaged together, or they could be integrated into one. An example of an integral combination product would be your EpiPen device or insulin pen device, where the device contains the insulin, which is the medicine, and the actual device that administers the medicine, and the syringe itself is the medical device.
Medicine: As per the Medicinal Products directive – any substance or combination of substances presented as having properties for treating or preventing diseases in human beings and then there is a second part to it. Any substance or combination of substances which may be used in, or administered to human beings, either with a view to restoring, correcting, or modifying physiological functions by exerting a pharmacological, immunological, or metabolic action, or to make a medical diagnosis.
Medical Device: Any instrument, apparatus, appliance, software, implant, reagent, material, or other article used alone, or in combination for human beings for a specific medical purpose. Some of the medical purposes are – to diagnose, prevent, monitor, treatment of diseases or to monitor, treat, or compensate for an injury or disability, and additionally, the investigation, replacements, or modification of the anatomy or of a physiological or pathological process or state. So this particular instrument, apparatus, or software does not achieve its principal intended action by pharmacological, immunological, or metabolic means.
If it does any of these by a pharmacological way, immunological way, or metabolic means, then it’s primarily a medicine.