MDD Certification: Proctological Medical Devices

Topical gel and anal solution for the treatment of anorectal disorders

The MDR (Medical Device Regulation), in force since May 2017 and fully applicable from May 2021, governs medical devices in Europe. Thanks to deadline extensions, devices compliant with the MDD Directive can continue to be marketed until December 31, 2027, for Class III and Class IIb implantable devices, and until December 31, 2028, for Class IIb, II, a and I devices.

We have obtained an extension of the MDR transitional period beyond May 26, 2024, for our legacy Class I, IIa, and III devices, confirming MDR compliance through an application submitted to the notified body. We have also signed a contract with the notified body to ensure market continuity and regular surveillance of each legacy device.

The well-being of the anal and perianal area is often compromised by unpleasant and debilitating conditions such as hemorrhoids, fissures, irritations, eczema, and inflammation. These are common issues that require effective, safe, and well-tolerated solutions. It is essential to intervene with targeted products that act deeply without compromising the skin’s natural balance, whether due to excessive physical activity, an incorrect lifestyle or physiological changes such as pregnancy.

For this reason, we have developed a topical proctological line composed of two Class I medical devices, designed to offer a natural and highly tolerable approach to the daily management of these conditions. Both devices – an anal gel and an anal solution – are compliant with MDR, and thanks to the regulatory extension, they remain regularly available on the European market.

Idanil Anal Gel – Natural anal gel for immediate relief

The first product in the line is Idanil Anal Gel, an anal gel with a pleasant texture and a formulation rich in natural active ingredients, developed to ensure fast relief and effective protection of the treated area. Each tube contains 30 ml of product and has a practical reusable cannula for hygienic and precise application.

This emulgel is especially indicated for:

• Internal and external hemorrhoids
• Anal fissures
• Perianal irritations
• Eczema
• Supportive treatment pre- and post-anal surgery

Its effectiveness is based on a synergistic action:

• Aloe vera, Chamomile, and Mallow soothe mucous membranes and reduce itching
• Escin and Melilotus counteract edema and the sensation of heaviness
• Hamamelis, Bisabolo,l and Vitamin E act as anti-inflammatory and antioxidant agents
• Menthyl lactate provides an immediate refreshing sensation, ideal during painful flare-ups

This product does more than just provide relief: it actively promotes the healing of the anal mucosa and creates a protective barrier against bacteria and irritants. It is especially useful after childbirth, in sedentary individuals, in post-surgical patients, or in athletes who suffer from microtrauma in the perianal area.

Idanil Anal Solution – Anal solution with soothing, antibacterial, and regenerating action

Complementing the gel, our line includes Idanil Anal Solution, a topical anal solution particularly indicated for acute phases of pain, inflammation, or damage to the perianal mucosa. It is also ideal as a pre- and post-operative treatment and for managing more extensive or recurrent conditions.

The formula is based on selected functional ingredients with healing, antiseptic, and soothing properties:

• Aloe vera: reduces pain, redness, and itching with its refreshing and anti-inflammatory action
• Vitamin E: protects and regenerates tissues, strengthens capillaries, and fights free radicals
• Hyaluronic acid: deeply hydrates and stimulates skin regeneration
• Chlorhexidine digluconate: delivers effective antibacterial action, protecting the mucosa from infections
• Vitamin B2 (riboflavin phosphate): supports tissue repair and healing

Thanks to this composition, Idanil Anal Solution is recommended for:

• Hemorrhoids
• Anal fissures
• Perianal eczema
• Anal erythema
• Relief from localized itching and pain

The barrier effect provided by hyaluronic acid helps isolate the mucosa from further irritation, promoting fast and natural recovery.

Complete support for anorectal health

Both devices in our proctological line are designed to meet different but complementary needs. The gel is ideal for daily and long-term use, while the solution is particularly effective during acute or inflammatory phases, thanks to its ability to act on pain, infection and inflammation.

The target audience is broad: from patients with chronic conditions, athletes, postpartum women, and sedentary individuals, to those requiring gentle topical treatments following surgery or invasive therapies.

In addition to offering a line of MDR-compliant proctological medical devices, we are manufacturers of medical devices. Thanks to our internal know-how, we develop market-ready products and custom formulations in private label or contract manufacturing, responding precisely to the specific needs of each client.

If you are interested in distributing our products on private labels or under our brand Pjpharma