BORDERLINE PRODUCTS: MEDICAL DEVICES / MEDICINAL PRODUCTS as per MDR
Thanks to new recommendations provided by the European Commission\’s Medical Device Coordination Group , developers trying to determine whether their items are medicines or devices now have better definitions (MDCG).It is quite simple to determine if a product is a device covered by the Medical Devices Regulation 2017/745 or a medication covered by Directive 2001/83/EC on the Community law related to medicinal items for human use (MPD).
Other items, such as medical devices that include a substance that would otherwise be designated a drug, aren\’t always apparent whether they\’re covered by the MDR or the MPD. By offering precise definitions of various types of products and clarifying how they differ, the new MDCG guideline document aims to clarify how developers may find the suitable regulatory framework for these so-called \”borderline\” scenarios.
Definition:
Borderline products are ones for which it is unclear whether they come under MDR or MDP from the start. If the product is subject to MDR, it must comply with MD Article 2(1) and must not be within the scope of MDR Article 1(6).
- The team of Operon strategist guide their clients to classify their product and provide regulatory services according to it . AS a CE mark medical devices consultant, we are providing quality services to our clients worldwide . If you want to avail any of our service do contact us or whatsapp us your requirement, will be happy to serve you.
Accessory of medical device Article 2(2) MDR
For a medical device to be considered an accessory, it must be employed in line with its original purpose or expressly and directly enhance the medical device\’s medical functioning in terms of its desired uses.
Medicinal product (Article 1 (2) MDR)
Any chemical or combination of substances that is claimed to have the ability to treat or prevent illness in humans.
How to determine if a product fulfills the definition of a medical device as per MDR ?
Flowchart for determining if a product fulfills the definition of a medical device .
Integral combinations of medical devices and medicinal products are governed as medicinal products.
Under this category contains devices designed to administer a medicinal product and in which the device and the combination of drugs are combined into a single integral component that is intended only for use in the specified combination and is not reusable (MDR, Article 1(9) second subparagraph). It also includes devices that include a medicinal product as an integral element and when the medicinal item\’s action is more important than the device\’s (MDR, Article 1(8) second statement).
Integral medical device and drug products combinations regulated as medicinal products are some examples.
– Aerosols containing a medicinal product
– Nebulisers pre-charged with a specific medicinal product
– Patches for transdermal drug delivery
– Syringes prefilled with a medicinal product
Medical device for administering pharmaceuticals products
Specially this category applies to devices that are designed to dispense a medical product within the meaning of the MPD but are not integral to the medicinal product.
In this scenario, the MDR applies to the device, notwithstanding the rules of Directive 2001/83/EC regarding the medical product.
Examples of medical devices for administration of medicinal products
– Drug delivery pumps
– Implantable infusion pumps
– Reusable iontophoresis devices .
Medical devices incorporating, as an essential component , an ancillary medicinal product
The MDR defines the specific instance of medical devices that include as an integral part a substance that, that when used separately, would be taken into account a medicinal product under Article 1 of the MPD, including a medicinal product derived from human blood or human plasma, with a secondary action to the device\’s primary action.
For the sake of simplicity, these are referred to in this article as devices that include an auxiliary medical product as an integral element. Also includes the herbal medicine.
Examples of medical devices incorporating, as an integral part, an ancillary medicinal product
- Catheters coated with heparin or an antibiotic agent
- Bone cements containing antibiotic
- Root canal fillers which incorporate medicinal products with ancillary action to that of the device
- Soft tissue fillers incorporating local anaesthetics
- Bone void filler containing growth factors
- Condoms coated with spermicides
- Electrodes with steroid-coated tip
- Wound dressings, surgical or barrier drapes (including tulle dressings) with antimicrobial agent
- Intrauterine contraceptives containing copper or silver.
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