Microneedling: How It Works, Results, Cost & What to Expect

This article is for informational purposes only. Consult a licensed esthetician or dermatologist before starting any new treatment.

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What Is Microneedling?

Microneedling --- also called collagen induction therapy (CIT) or percutaneous collagen induction (PCI) --- is a minimally invasive dermatological procedure that uses fine, sterile needles to create hundreds of controlled micro-injuries in the skin's surface. These tiny punctures trigger the body's natural wound-healing cascade, stimulating the production of new collagen and elastin fibers that remodel and strengthen the skin from within.

The concept is not new. Dermatologists have understood for decades that controlled skin injury can prompt regeneration. But modern microneedling devices --- from motorized pens like the SkinPen and Morpheus8 to radiofrequency-enhanced systems --- have refined the technique into one of the most versatile and evidence-backed treatments in aesthetic dermatology today.

You can explore the full treatment profile, including provider listings near you, on our microneedling treatment page.

How Microneedling Works: The Science of Collagen Induction

Understanding why microneedling produces visible results requires a brief look at what happens beneath the skin's surface. The procedure activates a three-phase biological response, as described in a comprehensive 2024 review published in Cureus (PMC):

Phase 1: Inflammation (Days 1--3) The micro-injuries immediately trigger the release of growth factors, cytokines, and inflammatory mediators. Platelets aggregate at the wound sites, and neutrophils begin clearing cellular debris. This is the phase responsible for the redness and mild swelling you see immediately after treatment.

Phase 2: Proliferation (Days 3--14) Fibroblasts --- the cells responsible for building structural proteins --- migrate to the wounded areas and begin producing type III collagen, elastin, glycosaminoglycans, and proteoglycans. New blood vessels form (angiogenesis), delivering nutrients to the remodeling tissue. This is when the skin begins to look noticeably smoother and more hydrated.

Phase 3: Remodeling (Weeks 2--12+) The initial type III collagen is gradually replaced by stronger, more organized type I collagen --- the same type that gives youthful skin its firmness and resilience. This conversion process continues for months after treatment, which is why results improve progressively over 3--6 months.

There is also an electrical component to the process. Micro-injuries cause a rise in electrical potential (approximately -100 mV) at the wound site, creating what researchers call a "demarcation current" that further stimulates cellular activity and growth factor release (Indian Journal of Dermatology, Venereology and Leprology, 2016; PMC).

The net effect is measurable. A landmark study by Aust et al. published in the Journal of Plastic, Reconstructive & Aesthetic Surgery (2008) found that four microneedling sessions spaced one month apart produced up to a 400% increase in collagen and elastin deposition at six months post-treatment, along with a 40% increase in epidermal thickness at one year.

What the Research Shows: Clinical Evidence for Microneedling

Microneedling is one of the more thoroughly studied aesthetic procedures. Below is a summary of the strongest clinical evidence available.

Acne Scars

Acne scarring is the most well-researched indication for microneedling. A 2022 systematic review and meta-analysis of randomized controlled trials published in Aesthetic Plastic Surgery (PubMed) confirmed statistically significant objective scar improvement with microneedling monotherapy.

A clinical study published in The Journal of Clinical and Aesthetic Dermatology found that after a series of microneedling sessions, 18% of patients reported 75--100% improvement in acne scarring, 24.4% reported 50--74% improvement, and 55% perceived 25--49% improvement in their acne scars (JCAD).

The American Academy of Dermatology notes that microneedling can fade acne scars by 50--70% when performed over 3--5 sessions spaced 2--4 weeks apart.

A 2024 literature review published in Aesthetic Medicine examining microneedling studies from 2020--2024 reaffirmed that microneedling remains an effective treatment for acne scars, with all 33 analyzed studies showing measurable improvement in scar appearance.

Fine Lines and Wrinkles

A histologic study published in JEADV (2022) demonstrated that fractional radiofrequency microneedling produced measurable increases in dermal collagen density and reorganization in periorbital wrinkles. Standard microneedling also shows efficacy for fine lines, with a comprehensive 2024 review in Cureus noting consistent improvements in skin texture and elasticity across multiple trials.

Hyperpigmentation and Melasma

Microneedling has shown particular promise for pigmentation disorders. A 2025 systematic review published in Cureus (PMC) found that microneedling combined with topical agents like tranexamic acid or vitamin C achieved significant improvement in melasma severity scores compared to topical therapy alone.

Skin Rejuvenation

For overall skin rejuvenation, a 2025 split-face study published in Scientific Reports (Nature) compared fractional microneedle radiofrequency with standard microneedling and found that treated sides exhibited increased proliferation of non-senescent fibroblasts, reduced senescent fibroblasts, and elevated collagen and elastin levels --- essentially reversing markers of skin aging at the cellular level.

Drug Delivery Enhancement

Beyond its standalone benefits, microneedling dramatically increases transdermal absorption of topical agents. The micro-channels created during treatment allow serums, platelet-rich plasma (PRP), and other active ingredients to penetrate far deeper than they would through intact skin. This is why many providers pair microneedling with growth factor serums or PRP for enhanced results.

See all microneedling studies on our research page.

Who Is Microneedling Best For?

Microneedling is remarkably versatile, but it delivers the strongest results for specific concerns and skin types.

Ideal Candidates

• Acne scars --- Particularly atrophic (depressed) scars including rolling, boxcar, and ice pick types. This is the most evidence-supported indication.
• Fine lines and early wrinkles --- Especially around the eyes, mouth, and forehead where skin is thinner.
• Uneven skin texture --- Rough, dull, or bumpy skin responds well to the resurfacing effects of microneedling.
• Hyperpigmentation --- Post-inflammatory hyperpigmentation (PIH), sun spots, and melasma (when combined with appropriate topical agents).
• Enlarged pores --- The collagen remodeling process can tighten and reduce the appearance of pores.
• Mild skin laxity --- Particularly with RF microneedling, which adds a thermal tightening component.
• Stretch marks --- Emerging research supports efficacy for striae on the abdomen, thighs, and arms.

Who Should Avoid Microneedling

According to the American Academy of Dermatology and the FDA, microneedling is not recommended for individuals with:

• Active acne breakouts or skin infections in the treatment area
• A history of keloid or hypertrophic scarring
• Active cold sore outbreaks (herpes simplex) --- microneedling can trigger flare-ups
• Blood clotting disorders or current use of blood thinners
• Active eczema, psoriasis, or rosacea in the treatment zone
• Pregnancy (due to insufficient safety data)
• Recent use of isotretinoin (Accutane) within the past 6 months

Skin Tone Considerations

One of microneedling's significant advantages over laser treatments is its safety profile across all skin tones. The 2024 comprehensive review in Cureus specifically noted that microneedling is a "viable resurfacing option for skin of color" with fewer adverse sequelae than ablative laser procedures. This makes it an excellent choice for patients with Fitzpatrick skin types IV--VI who may be at higher risk for post-inflammatory hyperpigmentation from laser treatments.

Not sure if microneedling is the right treatment for you? Take our treatment quiz to get a personalized recommendation.

The Treatment Process: What to Expect Before, During, and After

Before Your Appointment

2--4 weeks before:

• Your provider may recommend starting a topical retinoid (vitamin A) and vitamin C serum to prime your skin's collagen-production pathways
• Discontinue any exfoliating acids (glycolic, salicylic, lactic) at least 5--7 days before treatment
• Avoid prolonged sun exposure and tanning

48 hours before:

• Stop using retinol or retinoid products
• Avoid anti-inflammatory medications (ibuprofen, aspirin) that can increase bleeding risk
• Do not wax or use depilatory creams on the treatment area

Day of treatment:

• Arrive with clean, makeup-free skin
• Avoid caffeine if you are prone to sensitivity (it can increase discomfort)

During the Procedure

A standard microneedling session takes 30--60 minutes depending on the treatment area. Here is what happens step by step:

1. Cleansing --- Your provider thoroughly cleanses the skin and may apply an antiseptic solution.

2. Numbing --- A topical anesthetic cream (typically lidocaine-based) is applied and left on for 20--30 minutes. This significantly reduces discomfort.

3. Treatment --- Using a motorized microneedling pen (such as SkinPen, Dermapen, or similar FDA-cleared device), the provider passes the device across the skin in a systematic pattern. Needle depth is adjusted for different facial zones --- typically 0.5--1.0 mm for the forehead and around the eyes, and 1.5--2.5 mm for cheeks and areas with deeper scarring.

4. Serum application --- Many providers apply hyaluronic acid, growth factor serums, or PRP during or immediately after needling to take advantage of the enhanced absorption through the micro-channels.

5. Post-treatment care --- A calming serum or mask is applied, followed by sunscreen if you are leaving during daylight hours.

Pain level: Most patients describe the sensation as a mild scratching or vibrating feeling. With topical numbing, discomfort is typically rated 2--4 out of 10. Areas with thinner skin (around the nose, temples, and jawline) may be more sensitive.

After Treatment

Immediately after the procedure, your skin will look red and feel warm --- similar to a moderate sunburn. This is completely normal and is a sign that the inflammatory healing cascade has been activated.

Your provider will give you specific aftercare instructions, which typically include:

• Apply only gentle, fragrance-free products for the first 48--72 hours
• Use a hyaluronic acid serum to keep skin hydrated
• Apply broad-spectrum SPF 30+ sunscreen daily (mineral/physical sunscreen is preferred in the first few days)
• Avoid makeup for 24 hours post-treatment
• Do not exercise or expose yourself to excessive heat for 24--48 hours
• Avoid swimming pools, saunas, and hot tubs for 72 hours
• Do not use retinoids, AHAs, BHAs, or vitamin C serums for at least 48--72 hours

Recovery and Downtime: A Day-by-Day Timeline

One of microneedling's biggest advantages is its short recovery period. Here is what to expect day by day:

Day 1 (Treatment Day)

Skin appears noticeably red, similar to a sunburn. You may experience mild swelling, warmth, and tightness. Some patients notice pinpoint bleeding during or immediately after the procedure, which resolves quickly. Keep skin hydrated with hyaluronic acid and avoid touching your face unnecessarily.

Day 2

Redness begins to fade but remains visible. Skin may feel dry, tight, and slightly tender. Swelling, if present, typically peaks on day 2 and begins to subside. Continue gentle hydration. Most patients can return to work with mineral makeup for light coverage if needed.

Days 3--4

Redness continues to diminish significantly. Light flaking or peeling may begin as the top layer of skin sheds. This is a sign of healthy cell turnover --- do not pick at or manually exfoliate the skin. You may notice a slight "glow" as fresh skin emerges underneath.

Days 5--7

Most visible signs of treatment have resolved. Peeling tapers off, and skin feels smoother and more even. You can typically resume your full skincare routine, including retinoids and active acids, by day 5--7 unless your provider advises otherwise.

Weeks 2--4

Skin continues to improve as collagen production ramps up. You may notice pores appearing smaller, texture becoming more refined, and a general luminosity to the skin. This is when early results become apparent.

Months 1--3

The most significant improvements in scarring, fine lines, and firmness appear during this window as type III collagen converts to type I collagen and the dermal matrix continues to remodel.

Months 3--6

Final results become visible. The full extent of collagen remodeling is realized, and this is when before-and-after comparisons show the most dramatic differences.

Important note: Downtime duration can vary based on needle depth, treatment intensity, and individual healing response. Superficial treatments (0.25--0.5 mm) may cause redness that resolves within hours, while aggressive treatments (2.0--2.5 mm) may produce redness and peeling lasting up to 7--10 days.

Cost Breakdown: How Much Does Microneedling Cost?

Microneedling pricing varies significantly based on geographic location, provider credentials, treatment type, and what add-ons are included. Here is a realistic breakdown based on 2025--2026 pricing data.

Standard Microneedling

RF Microneedling (Morpheus8, Vivace, Genius, Potenza)

Microneedling with PRP ("Vampire Facial")

Pricing by City

Geographic location is one of the biggest factors affecting cost. Here is what you can expect in major markets:

Looking for microneedling providers in your area? Browse listings in Los Angeles, New York, and other cities on SpaLens.

What Affects the Price

• Provider credentials --- Board-certified dermatologists and plastic surgeons typically charge more than medical spas or estheticians
• Device used --- FDA-cleared devices like SkinPen command premium pricing; RF devices like Morpheus8 are the most expensive
• Treatment area --- Full face costs more than targeted treatment of specific scars or zones; body treatments (neck, chest, hands) add additional cost
• Add-ons --- PRP, growth factor serums, exosomes, and LED light therapy add $100--$500+ per session
• Package discounts --- Most providers offer 10--20% discounts when you purchase a series of 3--6 sessions upfront

Is Microneedling Covered by Insurance?

Microneedling is classified as a cosmetic procedure and is not covered by health insurance in virtually all cases. However, many providers offer financing through CareCredit, Cherry, or Afterpay/Klarna. Some HSA and FSA accounts may cover microneedling if your dermatologist documents it as medically necessary for scar treatment --- ask your provider and benefits administrator.

Risks and Side Effects: What the Clinical Data Shows

Microneedling has a strong safety profile, but no procedure is without risk. A 2021 systematic review published in the Journal of Clinical and Aesthetic Dermatology (PubMed) analyzed 51 clinical articles covering 1,029 patients and provides the most comprehensive safety data available.

Common Side Effects (Expected and Temporary)

These are considered normal parts of the healing process and resolve on their own:

• Erythema (redness) --- Nearly universal; lasts 24--72 hours for standard treatments, up to 7 days for aggressive treatments
• Edema (swelling) --- Common, especially around the eyes; resolves in 1--3 days
• Procedural pain --- Mild to moderate even with numbing; resolves immediately after treatment
• Skin dryness and flaking --- Peaks at days 3--5; part of normal cell turnover
• Skin tightness --- Resolves within 48 hours as hydration normalizes

Uncommon Side Effects

• Post-inflammatory hyperpigmentation (PIH) --- More likely in Fitzpatrick skin types III--VI and when improper sun protection is used post-treatment. A 2021 systematic review in Dermatologic Surgery (PubMed) identified PIH as the most common non-transient adverse effect
• Prolonged redness --- Lasting beyond 7 days; more common with deeper needle depths and RF microneedling
• Irritant contact dermatitis --- Can occur from topical products applied too soon after treatment
• Cold sore reactivation --- Patients with herpes simplex virus history should take prophylactic antivirals

Rare but Serious Complications

• Infection --- Bacterial infections can occur if sterile technique is not maintained; significantly more common with at-home devices
• Tram-track scarring --- Caused by improper technique, excessive pressure, or using a rolling device incorrectly
• Granulomatous reactions --- Rare inflammatory nodules that can form, particularly when certain topical products are introduced through the micro-channels
• Allergic reactions --- Typically to topical agents applied during treatment, not to the needling itself

Risk Factors That Increase Complications

According to the FDA and published clinical data, the following factors increase the likelihood of adverse events:

• Active skin infections at the treatment site
• Darker skin tones (Fitzpatrick IV--VI) without proper pre- and post-treatment protocols
• Metal allergies (relevant for some needle materials)
• Use of blood thinners
• Treatment by untrained or unlicensed providers
• Use of non-sterile or counterfeit devices

The bottom line: when performed by a qualified, licensed provider using FDA-cleared devices in a sterile environment, microneedling has an excellent safety record. The vast majority of side effects are mild, predictable, and self-resolving.

RF Microneedling vs. Standard Microneedling

Radiofrequency (RF) microneedling has rapidly gained popularity as an advanced version of standard microneedling. Understanding the differences helps you determine which option is right for your goals and budget.

How RF Microneedling Differs

Standard microneedling creates micro-injuries using needles alone, relying entirely on the body's wound-healing response to generate new collagen. RF microneedling adds a second mechanism: insulated or non-insulated needles deliver radiofrequency energy into the dermis, generating controlled thermal injury that causes immediate collagen contraction and stimulates additional collagen production.

Popular RF microneedling devices include Morpheus8, Vivace, Genius, Potenza, and Scarlet SRF.

What the Research Says

A 2025 split-face study published in Scientific Reports (Nature) directly compared fractional microneedle radiofrequency (FMR) with standard microneedling and found that FMR-treated sides showed:

• Increased proliferation of non-senescent (healthy) fibroblasts
• A reduced number of senescent (aging) fibroblasts
• Higher levels of collagen and elastin

A 2024 review published in Plastic and Reconstructive Surgery -- Global Open (PMC) confirmed that RF microneedling is particularly effective for skin laxity, deeper acne scars, and advanced signs of aging where the thermal component provides additional tightening that standard microneedling cannot achieve.

For acne scarring specifically, a 2025 study reported in Dermatology Times found that 50% of patients treated with fractional RF microneedling combined with subcision showed acne scar reduction by three grades, confirming its efficacy as a monotherapy for scarring.

Head-to-Head Comparison

Which Should You Choose?

Choose standard microneedling if:

• Your primary concerns are mild texture issues, enlarged pores, superficial scarring, or overall skin rejuvenation
• You want shorter downtime and lower cost
• You are new to aesthetic treatments and want to start conservatively

Choose RF microneedling if:

• You have deeper acne scars (especially ice pick and boxcar types)
• Skin laxity or sagging is a concern
• You want more dramatic tightening results
• You have tried standard microneedling and want to escalate treatment intensity

For a detailed side-by-side analysis with other popular treatments, visit our microneedling vs. chemical peel comparison.

How to Choose a Microneedling Provider

The skill and qualifications of your provider directly affect your results and safety. The American Academy of Dermatology explicitly recommends seeing a board-certified dermatologist for microneedling, noting that "when microneedling is performed by someone who lacks medical training, there's an increased risk of developing side effects like infection, scarring, or long-lasting skin discoloration."

What to Look For

Credentials:

• Board-certified dermatologist or plastic surgeon (highest level of training)
• Licensed nurse practitioner or physician assistant under physician supervision
• Licensed and certified master esthetician (for standard microneedling; RF microneedling typically requires a medical provider in most states)

Device quality:

• Ask what device they use --- FDA-cleared devices (SkinPen is the first and only FDA-cleared microneedling device for acne scars) offer the highest safety and efficacy standards
• For RF microneedling, Morpheus8, Genius, and Vivace are among the most widely studied platforms

Facility standards:

• Clean, professional treatment rooms with proper sterilization protocols
• Single-use, disposable needle cartridges (never shared between patients)
• Proper medical waste disposal

Consultation quality:

• A thorough provider will examine your skin, discuss your goals and medical history, and set realistic expectations before recommending treatment
• Be wary of providers who push aggressive treatment plans without an initial assessment

Red Flags

• Extremely low prices ($100 or less per session) --- may indicate counterfeit devices or untrained staff
• No consultation before treatment
• Reusing needle cartridges
• Inability to name the specific device being used
• Unwillingness to discuss potential side effects or contraindications

Browse verified microneedling providers in your city on SpaLens.

At-Home vs. Professional Microneedling

The proliferation of at-home derma rollers and microneedling pens has made this a common question. The short answer: at-home devices and professional treatments are fundamentally different in terms of efficacy, safety, and results.

At-Home Derma Rollers and Pens

At-home devices typically use needle lengths of 0.1--0.25 mm (sometimes up to 0.5 mm). At these depths, the needles primarily affect the epidermis (outermost skin layer) and do not penetrate deep enough to reach the dermis where true collagen remodeling occurs.

What they can do:

• Temporarily improve product absorption
• Provide a mild, surface-level exfoliation effect
• Create a subtle glow or smoothing effect

What they cannot do:

• Produce the collagen induction response seen in clinical studies (which use 1.0--2.5 mm depths)
• Meaningfully improve acne scars, wrinkles, or skin laxity
• Deliver RF energy

Safety Concerns with At-Home Use

The FDA has raised specific concerns about at-home microneedling devices. Key issues include:

• Infection risk --- Even with regular cleaning, at-home devices cannot achieve the sterility of single-use, disposable professional cartridges. Skin infections, including staph infections, are more common with home use.
• Inconsistent depth --- Derma rollers enter the skin at an angle as the wheel rotates, creating V-shaped wounds that can cause micro-tears rather than clean channels. Professional pens enter vertically, creating uniform micro-channels.
• No adjustability --- Rollers operate at a fixed depth, while different facial zones require different needle depths for safe, effective treatment.
• Lack of numbing --- Without professional-grade topical anesthetics, deeper home treatments are painful and may cause users to apply uneven pressure.

The Verdict

At-home derma rollers can serve as a gentle maintenance tool between professional sessions --- particularly for enhancing serum absorption. However, they are not a substitute for professional treatment and should never be used to attempt deep needling at home. For any clinical concern (scarring, wrinkles, hyperpigmentation), professional microneedling is the evidence-based choice.

If cost is a barrier, many providers offer payment plans or package discounts that bring per-session prices down significantly. Use our treatment finder to compare providers and pricing in your area.

Frequently Asked Questions

How many microneedling sessions do I need to see results?

Most providers recommend a series of 3--6 sessions spaced 4--6 weeks apart for optimal results. The exact number depends on your specific concern: mild texture issues may improve in 2--3 sessions, while moderate to severe acne scars typically require 4--6 sessions. The American Academy of Dermatology notes that acne scars may require 3--5 treatments to achieve 50--70% improvement. You will notice initial improvements (smoother texture, a healthy glow) within 2--4 weeks of your first session, but the most significant collagen remodeling occurs over 3--6 months as type III collagen converts to type I collagen.

Does microneedling hurt?

With topical numbing cream (applied 20--30 minutes before treatment), most patients rate the discomfort at 2--4 out of 10 for standard microneedling and 3--5 out of 10 for RF microneedling. The sensation is commonly described as a scratching or vibrating feeling. Certain areas --- around the nose, temples, and jawline --- tend to be more sensitive. The procedure is very tolerable for the vast majority of patients, and the numbing cream makes a significant difference. If you are concerned about pain, discuss additional numbing options with your provider.

Can microneedling make acne scars worse?

When performed correctly by a qualified provider, microneedling does not make acne scars worse. In fact, every study in a 2024 literature review in Aesthetic Medicine examining microneedling for acne scars from 2020 to 2024 showed measurable improvement. However, there are scenarios where complications can occur: treatment during an active breakout can spread bacteria and worsen inflammation; improper technique can cause tram-track scarring; and treatment on keloid-prone skin can trigger abnormal scar formation. This is why a thorough consultation and provider selection are critical. Always ensure any active acne is fully resolved before undergoing microneedling.

How long do microneedling results last?

Results from a complete microneedling series can last 12--18 months or longer, depending on your skin condition, age, and maintenance routine. The collagen produced through microneedling is real, structural collagen that integrates into your skin's architecture --- it does not simply disappear. However, natural aging continues, and environmental factors (UV exposure, pollution, lifestyle) gradually break down collagen over time. Most dermatologists recommend 1--2 maintenance sessions per year after completing your initial series to sustain results. A consistent skincare routine with retinoids, vitamin C, and daily SPF will help extend the longevity of your results.

Is microneedling safe for dark skin tones?

Yes. One of microneedling's key advantages over laser treatments is its established safety across all Fitzpatrick skin types, including types IV--VI. The 2024 comprehensive review in Cureus specifically identified microneedling as a "viable resurfacing option for skin of color." Unlike ablative lasers, microneedling does not target melanin and therefore carries a lower risk of post-inflammatory hyperpigmentation (PIH) or hypopigmentation. That said, patients with darker skin tones should still take precautions: work with a provider experienced in treating skin of color, use lower needle depths initially, follow strict sun protection protocols post-treatment, and consider a test patch before full-face treatment. RF microneedling with insulated needles (which confine heat delivery to the dermis) is considered the safest RF option for darker skin tones.

Related Reading

• HydraFacial Guide: Is It Worth It?
• Chemical Peel Guide: Types, Cost & Results
• Find Your Perfect Treatment

-- The SpaLens Team

References

• American Society of Plastic Surgeons (ASPS), 2024 Plastic Surgery Statistics Report
• American Society for Dermatologic Surgery (ASDS), 2024 Consumer Survey on Cosmetic Dermatologic Procedures
• American Academy of Dermatology (AAD), Chemical Peels Overview, 2024
• U.S. Food and Drug Administration (FDA), Aesthetic Devices Premarket Notification Database, 2023
• Journal of the American Academy of Dermatology (JAAD), Cosmetic Dermatology Reviews, 2023
• National Institutes of Health, Cutaneous Aging and Aesthetic Procedures, PMC 2022
• ASDS, Skin of Color Considerations in Aesthetic Procedures, 2023
• American Society of Plastic Surgeons, Non-Invasive Body Contouring Patient Guide, 2024
• FDA Center for Devices and Radiological Health, Aesthetic Treatment Safety Communications, 2024
• AAD, Sunscreen FAQs and Fitzpatrick Skin Type Guidance, 2024
• Alster TS, Microneedling Outcomes, Dermatol Surg, 2023
• Hession MT, RF Microneedling Review, J Cosmet Dermatol, 2023
• AAD, Microneedling Overview, 2024
• ASDS, Microneedling Consumer Guide, 2024
• FDA, Microneedling Device Regulation, 2023