Placing your device on the market

MDR Article 117 covers devices intended to administer a medicinal product, where they form a single integral product intended exclusively for use in the given combination and which is not reusable (drug-device combination products).

Introduced by the European Commission, MDR Article 117 requires manufacturers of these medicinal products to seek a Notified Body Opinion (NBOp). Once the Notified Body confirms whether the device is compliant with the relevant General Safety and Performance Requirements (GSPR) and provides a NBOp Report, the manufacturer can proceed with the Market Authorisation Application (MAA) for their medicinal product.

BSI was the first ever Notified Body to issue a NBOp to a manufacturer for a drug-device combination product under MDR Article 117. We truly understand the challenges medical devices manufacturers face in bringing compliant products to market efficiently and safely. We offer a range of flexible product review services (Standard and Dedicated) providing you with efficient pathways to bring your product to market.

Devices that incorporate as an integral part a medicinal substance or human blood derivative that has an action ancillary to that of the device may fall under MDR Rule 14 or UK MDR 2002 Part II (MDD) (Rule 13) provided that all associated legislative requirements have been considered to conclude that classification is appropriate under MDR or UK MDR 2002.

Where classification is confirmed a conformity assessment is conducted by BSI, and additional consultation with an EU Medicines Competent Authority or the EMA (in cases of ancillary human blood derivative) and/or UK MHRA, when applicable, is completed by analogy to Annex I, Directive 2001/83/EC.

Medical devices utilizing tissues or cells of human origin, or their derivatives may fall under MDR (Rule 18) provided that all associated legislative requirements under MDR Article 1(6), Regulation (EC) No 1394/2007, and Directive 2004/23/EC have been considered to conclude that classification is appropriate under MDR.  In instances where MDR classification is confirmed, a conformity assessment is conducted by BSI, and additional consultation with an EU Competent Authority is completed in accordance with Directive 2004/23/EC.  These devices do not currently fall within the scope of UK MDR 2002.

Medical devices utilizing tissues or cells of animal origin, or their derivatives, may also fall under MDR (Rule 18) or UK MDR 2002 Part II (MDD) (Rule 17).  Where the classification is confirmed, a conformity assessment is conducted by BSI against the requirements of EN ISO 22442 parts 1-3, and additional consultation is completed, where applicable, in accordance with Regulation (EU) 722/2012.

According to the MDR (Rule 21), a substance-based device is a device composed of substances or of combination of substances that are intended to be introduced in the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, with risk classification ranging from Class IIa – Class III depending on the route of administration and risks. Substance-based medical devices are health products:

• Composed of substances that are permitted in a medical device
• Acts via physicochemical action
• Do not achieve their principal intended action by pharmacological, immunological or metabolic means

Such devices may be similar in formulation to a medicinal product and may also be used in a similar way to a medicinal product and as such, these products are often borderline with medicinal products, with evidence to support the mode of action key.

For the highest risk substance-based devices that are systemically absorbed to achieve their intended purpose (Class III - Rule 21 first indent), in addition to the Conformity Assessment procedures conducted by BSI, a consultation procedure with a medicinal products competent authority or the EMA is necessary according to section 5.4 of Annex IX, MDR.

For all other substance-based devices, the conformity assessment procedure conducted by BSI must consider the relevant requirements laid down in Annex I of Directive 2001/83/EC for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions.

Consist of devices for processing and preservation of human cells, tissue or organs including in vitro fertilization (IVF) and assisted reproductive technologies (ART). Devices designed to support human gametes and embryos in vitro fall under the Medical Device Regulations (MDR).

Examples of devices used in Assisted Reproductive Technologies (ART) to process, hold, and preserve gametes and/or embryos include culture media, gamete washing and preparation media, mineral oil for overlay, cryopreservation media, culture plates, pipettes, and many more.

These devices carry unique risks and often contain medicinal substances or substances derived from animal origin, which require additional consultation processes.

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