Guide 

Start with intended purpose, not the word “cosmetic”

The EU Medical Devices Regulation (MDR), Regulation (EU) 2017/745, covers medical devices and specified products without an intended medical purpose. Annex XVI, group 4, includes equipment intended to reduce, remove or destroy adipose tissue. A non-medical aesthetic purpose therefore does not, by itself, place such equipment outside the MDR. Equipment with both medical and non-medical intended purposes must meet the applicable requirements for both. [2]

For Annex XVI products, Regulation (EU) 2022/2346 sets common specifications; its Annex V addresses this adipose-tissue equipment group. Regulation (EU) 2022/2347 reclassifies the active products in group 4 as class IIb, bringing notified-body involvement into their MDR conformity assessment. That is a rule for an identified product group, not a finding about every machine described online as “cavitation.” [3] [4]

Ask the manufacturer to explain how the machine’s design and stated purpose fit the claimed framework. Compare its label, instructions for use (IFU) and promotional claims: intended purpose is not confined to one sentence in a manual. A supplier cannot settle a contradiction simply by calling the machine cosmetic. [2]

Record each function separately: low-frequency non-focused ultrasound, focused mechanical ultrasound, thermal high-intensity focused ultrasound (HIFU), a 1 MHz ultrasound function, radiofrequency (RF), and other attachments are different descriptions. A frequency number or a shared console does not establish a common regulatory scope. Request a documented explanation of the supplied configuration rather than transferring another machine’s paperwork.

Match the declaration, certificate and instructions

The manufacturer’s EU Declaration of Conformity (DoC) is central. It identifies the product and applicable legal requirements and is issued under the manufacturer’s responsibility. A testing laboratory’s report, a supplier invoice and a training certificate serve different purposes. Your Europe also warns that voluntary certificates are not substitutes for the legally required CE assessment. [1] [5]

For an MDR declaration, Annex IV specifies manufacturer and, where applicable, authorised-representative details; traceable device identification and intended purpose; Basic UDI-DI; risk class; applicable legislation and common specifications; relevant notified-body and certificate information; and dated signatory details. Basic UDI-DI is a device-group identifier, not the serial number of your individual unit. [2] [5]

This is a practical reconciliation checklist, not a demand that every document print the unit’s serial number. A certificate or declaration can cover a defined family; the manufacturer must provide an unambiguous bridge from that scope to the delivered model. Use the manufacturer’s explanation to resolve different commercial and technical model names.

Verify the notified body and the certificate’s scope

A notified body is designated to perform particular conformity-assessment tasks under particular legislation. Check the body in the official NANDO information system, using the relevant legislation and designation scope. Being listed for one framework is not authority to assess every product under another. The Commission’s medical-device page links to the MDR list. [6]

1. Find the issuer independently. Match its name and identification number to the official listing.
2. Check its designation. Confirm that the listed activities and device scope are relevant to the assessment being claimed.
3. Read the complete certificate. Request schedules, covered product lists and amendments referenced on the first page.
4. Confirm current status. Use the issuer’s official verification route or contact details to resolve authenticity, scope, suspension, withdrawal or an asserted extension.

Where a notified body participates in the relevant CE assessment, its identification number accompanies the marking. A number printed next to a logo is a verification lead, not proof that a supplied certificate covers this unit. Equally, no number is a reason to investigate the claimed route, rather than to pronounce every CE-marked product unlawful: some product frameworks permit self-assessment. [1]

Request evidence that supports the exact advertised outcome separately. For example, a contouring claim, a skin-tightening claim and a weight-loss claim are different questions. CE conformity is not a blank endorsement of all website promises or of another model’s clinical results.

A transition claim needs more than an end date

Regulation (EU) 2023/1194 amended the transitional provisions in 2022/2346. There are distinct routes involving clinical investigations, notified-body assessment without an intended clinical investigation, and certain older Medical Devices Directive certificates. Do not accept “Annex XVI has been delayed” as a complete explanation. [7] [8]

Ask for the exact paragraph relied upon and a dated eligibility explanation: the product’s lawful marketing history, continued compliance with the earlier applicable rules, relevant design or intended-purpose changes, and evidence of the investigation or notified-body milestones required by that route. Check conditions already due as well as future conditions. A new machine is not automatically eligible because a similarly named product was previously sold. [3]

The Commission-hosted transition Q&A is a useful navigation aid, but expressly says it is general information, not legal advice or a binding interpretation. Read it alongside the amended legislation. An expiry date alone is not enough to establish either continued validity or invalidity where a transition is asserted. [8]

Separate supplier duties from the salon’s duties

The manufacturer is responsible for conformity assessment, the supporting technical documentation, the declaration and marking. Importers and distributors have their own MDR verification obligations. If your business imports or supplies equipment, have its economic-operator role reviewed; being a salon does not answer that question. [1] [2]

As a service provider, confirm who may perform the procedure in the relevant country, what qualifications or supervision are required, and whether premises and insurance conditions are satisfied. These checks sit alongside the device file. The MDR preserves Member States’ powers over certain device-use restrictions and national health-service rules. Neither a CE logo nor a private training certificate grants blanket permission to practise throughout the EU. [2]

Keep the equipment file accessible to staff, reconcile IFU revisions with training, and retain a clear route for service support and incident escalation. These are document-control recommendations; they are not a universal international operating protocol.

A practical review before accepting equipment

1. Identify the delivered configuration. Record the label, model, unit serial number, applicators and documentation revision.
2. Request a written applicability explanation. It should connect the design, intended purpose and actual claims to the chosen framework.
3. Reconcile the documents. Link the DoC and any required certificate scope to the exact model and supplied functions.
4. Resolve inconsistencies. Ask the manufacturer or issuer for traceable clarification rather than accepting an edited screenshot.
5. Review the service separately. Check local operator authority, IFU-based training, client assessment and support arrangements before use.

Common mistakes that leave the review unfinished

• Treating a logo photograph as the complete compliance file.
• Accepting an ISO quality-management certificate as the device’s applicable CE assessment.
• Assuming every handpiece is covered because one function appears in a certificate.
• Using a frequency label to assign a device class.
• Confusing transition eligibility with an unconditional extension.
• Turning document checks into a guarantee of results.

Record unresolved scope or safety questions and seek qualified regulatory review. A brief supplier assurance does not close a mismatch between the intended purpose, declaration and certificate.

What a complete answer looks like

The useful question is not simply whether a machine “has CE.” It is whether the manufacturer can connect the exact machine and purpose to the applicable requirements, assessment documents and any transition being used—and whether your business is authorised and prepared to provide that specific service.