Guide 

EU product conformity and permission to operate are separate checks

The Medical Devices Regulation (MDR), Regulation (EU) 2017/745, extends its framework to specified products without an intended medical purpose. Annex XVI group 4 concerns adipose-tissue reduction, removal or destruction. The relevant common specifications (CS) are in Annex V of Implementing Regulation (EU) 2022/2346, alongside its general Annex I. [1] [2]

That product framework does not replace national rules governing who can perform a procedure. MDR Article 1(14) preserves Member-State restrictions on aspects outside the Regulation; Article 1(15) preserves national health-service and medical-care law, including rules restricting the use of certain devices to particular professionals or institutions. [1]

Practical consequence: Do not open a service file with “CE marked, therefore permitted.” Open it with two questions: “What is the lawful product route for this model?” and “What permits this operator to provide this service here?”

Start with intended purpose, not the word “cavitation”

Intended purpose includes the manufacturer’s description in the label, instructions for use (IFU), promotional statements and clinical evaluation. A salon cannot resolve a conflicting fat-reduction claim simply by describing the machine as a massage device. The manufacturer’s documented purpose and the applicable scope need to agree. [1]

Commission guidance MDCG 2023-5 explains that qualification comes before classification: establish whether the product belongs to an Annex XVI group and falls within the CS scope before assigning a class. The guidance considers purpose, technology, how the product functions and the targeted tissue. It is guidance, not a substitute for the legislation or a model-specific decision. [3]

• A stated purpose of reducing adipose tissue: Check Annex XVI group 4 and CS Annex V. For qualifying active products in that group, Article 1(b) of Implementing Regulation (EU) 2022/2347 sets class IIb. That is a rule for the defined group, not proof that every machine sold as cavitation belongs to it. [4]
• Skin tightening, massage or another purpose: Do not assign group 4 from a broad “body contouring” heading alone. Ask for the regulatory rationale for the actual purpose; being outside this group does not establish exemption from every other EU rule. [3]
• Both medical and non-medical purposes: The applicable requirements must be met cumulatively; the non-medical label does not cancel the medical-purpose requirements. [1] [3]

Low-frequency non-focused ultrasound, focused mechanical ultrasound, thermal high-intensity focused ultrasound (HIFU), a 1 MHz system and radiofrequency (RF) attachments should not be treated as interchangeable devices. Frequency alone does not resolve legal scope, conformity or user restrictions. Record the function and intended purpose of each attachment and confirm what the documents actually cover. This is a document-matching approach, not a classification decision for those technologies.

Match the documents to the machine in front of you

For equipment claiming full MDR conformity, request the EU declaration of conformity and the applicable notified-body certificate. A notified body is a designated conformity-assessment organization; its involvement is required for the active-product groups reclassified by 2022/2347. Check the issuing body and scope, rather than relying on a certificate image in a sales listing. [1] [4]

1. Identify the unit. Record the legal manufacturer, model, serial identifier and included attachments. Resolve any discrepancy between the nameplate, invoice, IFU and conformity documents.
2. Read the declared purpose. Confirm the tissue, function, intended user and use environment. Ask the manufacturer to explain inconsistent descriptions in writing.
3. Check the declaration. MDR Annex IV specifies identifying information, intended purpose, risk class, applicable legislation, CS references and notified-body details where applicable. A declaration citing only other legislation does not establish MDR conformity. [1]
4. Check the conformity-assessment scope. Establish which products the certificate covers and its current status with the issuer. Do not use a certificate for another manufacturer, model family or function as a substitute.
5. If transition is claimed, use the transition file. Request the exact legal provision, model-specific eligibility statement and evidence for the relevant milestones. A manufacturer relying lawfully on a transition needs to demonstrate that route; the absence of a final MDR certificate alone does not determine the answer. [5]
6. Review the operational information. Obtain the current IFU, safety information, training requirements and servicing instructions for the supplied configuration. Preserve the versions reviewed and who resolved any open question.

CE marking relates to conformity with applicable product requirements. It is not a guarantee of an individual client’s outcome, an endorsement of every marketing claim or a licence for the operator. Equally, a training provider’s certificate cannot replace the equipment’s conformity assessment. [1] [4]

Transition dates are conditional routes, not a blanket extension

The CS generally apply from 22 June 2023. The current accessible consolidated text of 2022/2346 incorporates the transition amendment in 2023/1194. Its Article 2 provides different routes; it does not allow every new or undocumented machine to remain on the market until the latest date shown below. [2] [6]

Table basis: consolidated CS Article 2, the amending act and the Commission’s transition Q&A. The Article 2(1) route also had a clinical-investigation application-notification condition for 22 June–22 December 2024; the current “investigation started” milestone does not erase earlier eligibility checks. [2] [5] [6]

The former Medical Devices Directive (MDD) certificate routes involve additional certificate dates and MDR Article 120 conditions. Obtain an exact-model assessment rather than treating an expired certificate as either automatically valid or automatically unusable. The Commission Q&A describes a manufacturer’s self-declaration of transition eligibility and supporting notified-body confirmation where relevant. Neither document grants salon practice permission. [5]

These provisions concern placing products on the market or putting them into service. An endpoint is not a universal instruction to discard every existing unit or a promise that a salon can keep operating regardless of local law, safety notices or maintenance status. Ask which regulatory event and which equipment history the advice concerns. [2] [5]

Verify the Member-State rules for the actual service

Use the country and, where relevant, regional or local jurisdiction where the procedure will take place. A course accepted by one training provider or a service offered elsewhere does not establish permission at your premises. The following is a verification workflow, not a claim that every jurisdiction imposes every requirement listed.

1. Describe the service precisely. Include the device, documented intended purpose, technology, whether the procedure is invasive, proposed setting and operator qualifications.
2. Separate the authorities. Ask the national medical-device competent authority about product scope or conformity questions. Ask the relevant health/professional authority about reserved procedures, operator qualifications and medical oversight. Confirm which authority handles premises requirements if applicable.
3. Obtain a written answer. Request the applicable legal provision, any required registration or qualification, restrictions on the procedure and the date of the guidance.
4. Check coverage separately. Confirm that your insurer covers the named service, operators and equipment. Insurance acceptance is an additional business check, not legal authorization.
5. Reassess meaningful changes. A different model, intended purpose, attachment, operator role or location calls for another review rather than copying the previous conclusion.

Keep the reply beside the equipment documents. MDR Articles 1(14)–(15) explain why an EU product file cannot replace this national check. No Member-State permission for a particular salon is established by this article. [1]

Annex V also matters after the paperwork check

For equipment within Annex V, the CS require manufacturers to provide training on safe and effective use. Section 5.5 states that liposuction, lipolysis and lipoplasty devices must not be used by lay persons in private environments. These are substantive limits; describing equipment as “cosmetic” does not remove them. They also do not establish that every non-invasive service is permitted for every salon operator. [2]

The Annex V IFU provisions cover contraindications, excluded body parts, adverse effects and warnings. Examples in its contraindication list include pregnancy, diabetes mellitus, uncontrolled hypertension, coagulation disorders or anticoagulant treatment, skin infections and open lesions. RF lipolysis has additional implant/metal-related provisions. Read the full applicable list and the exact IFU; these examples are not a complete screening form or a universal list for every device advertised as cavitation. [2]

Sections 6.6–6.7 require the IFU to instruct the user to give the consumer its specified information annex before treatment. That annex includes residual-risk information, reporting of undesirable side effects and a recommendation for a medical consultation with examination of the intended treatment areas. Invasive use has additional medical-environment and qualified-doctor requirements under Section 6.5. Do not transfer surgical provisions into a generic non-invasive salon protocol or omit provisions that apply to the actual device. [2]

Common mistakes that leave the question unresolved

• Checking only the CE logo: Match the legislation, model and conformity route.
• Calling all cavitation machines class IIb: Establish qualification and scope before applying the active-product rule.
• Accepting “valid until 2029”: Ask which transition provision applies and what demonstrates its conditions.
• Using a course certificate as permission: Verify the national professional requirements separately.
• Assuming a multifunction certificate covers every use: Resolve the covered configuration and intended purposes.
• Copying a neighbour’s legal answer: Confirm the equipment, service, operator and jurisdiction match.

Frequently asked questions

Can a manufacturer avoid Annex XVI by using the word “wellness”?

A label alone does not resolve scope. Compare the actual manufacturer-stated purpose across the IFU, label and promotional statements with the Annex XVI group and CS scope. An inconsistent description needs clarification, not a salon’s unilateral relabelling. [1] [3]

Does Annex XVI make non-medical equipment a treatment for obesity?

No. Annex V requires a warning that the covered procedures are not reliable weight-reduction methods and that devices have not been validated for treating clinically diagnosed obesity. Product regulation does not create that treatment indication. [2]

What if a supplier says the certificate is confidential?

Do not replace a missing scope check with an assurance that “all documents are in order.” Ask for enough model-specific information to verify the claimed conformity or transition with the manufacturer, issuer or competent authority. The full confidential technical file is a different question from establishing what documentation covers your equipment.

Does this guide establish compliance in the United Kingdom?

No. Its scope is EU product rules and the need to check individual EU Member-State practice requirements. It does not establish the applicable UK market-access route or practitioner permission.

The next decision for a salon owner

Build one file that connects the exact machine and its lawful product route to the documented national permission for the intended service. Leave unresolved questions visible. A complete file supports a reasoned decision; neither a logo, a course certificate nor a transition endpoint can make that decision alone.