Sep 19, 2023
Regulatory Requirements for EU MDR Annex XVI Devices: What You Need to Know
Aesthetic devices have lived on the fringe of device regulations for years. In Europe, the EU MDR brought common aesthetic devices (i.e., certain products without an intended medical purpose listed in Annex XVI) clearly under regulatory scrutiny – some for the first time. Even after the implementation of the EU MDR, regulatory obligations for these product manufacturers remained ambiguous – until now. The European Commission (EC) has published a series of regulations (and a Q&A document) clarifying what is required for non-medical-purpose products to comply with the MDR.
In this article, we’ll discuss the regulatory requirements, the products included under the scope of Annex XVI, and the transition timelines.
Key Regulations That Address Requirements for Annex XVI Products
EU MDR Article 1 introduces the concept of the Annex XVI devices. Article 1 states that the EU MDR applies to devices without an intended medical purpose (those listed in Annex XVI) as of the date of application of the relevant common specifications developed under Article 9.
The relevant common specifications for Annex XVI devices were published in December 2022 with a June 2023 date of application. The European Commission also published a regulation regarding the reclassification of active devices included in Annex XVI categories.
- Regulation (EU) 2022/2346 (commonly known as the “Annex XVI common specification”) introduced common specifications (CS) and transition deadlines for products listed in Annex XVI.
- In June 2023, the EC amended EU 2022/2346 with Regulation (EU) 2023/1194 mostly to align with the March 2023 EU MDR postponement, Regulation (EU) 2023/607.
- Regulation (EU) 2022/2347 addressed the reclassification of active devices listed in Annex XVI.
EU MDR Article 1 also clarifies that a device can have both a medical and a non-medical purpose. In these cases, the manufacturer must fulfill the cumulative requirements for devices with an intended medical purpose (i.e., the EU MDR) and those for devices without an intended medical purpose (i.e., the Annex XVI common specification).
Which Products Are Included in Annex XVI of the EU MDR?
Annex XVI describes six groups of devices without an intended medical purpose that fall under the scope of the EU MDR. The annex articulates the functions and intended purposes of the products in question, which in lay terms includes:
- Contact lenses
- Implants (e.g., breast or contouring implants)
- Dermal fillers (e.g., hyaluronic acid or calcium hydroxylapatite)
- Body sculpting equipment (e.g., liposuction)
- Lasers (e.g., for skin resurfacing or hair removal)
- Brain stimulation (e.g., transcranial stimulation)
The EC could add new groups of products to the annex at any time, so be sure to stay informed about amendments if you manufacture a similar product.
EU MDR Requirements for Nonmedical-Purpose Devices
A common misconception is that the Annex XVI requirements are a separate path from the other EU MDR conformity assessment routes (Annexes IX, X, XI) for these types of products. In fact, manufacturers of Annex XVI products must fulfill both the applicable Annex XVI common specification requirements and all applicable requirements under the EU MDR, such as:
- Conformity assessment: Identify the appropriate conformity assessment procedure based on device classification (self-assessment or involving a Notified Body).
- Technical documentation: Prepare comprehensive technical documentation that includes device specifications, design information, risk assessments, clinical data, etc.
- Unique Device Identification (UDI): Assign a unique device identifier (UDI) to your device for traceability and monitoring purposes.
- Labeling and instructions for use: Ensure clear and accurate labeling and instructions for use that provide information to patients, users, and healthcare professionals.
- Quality management system (QMS): Implement a QMS that covers the design, manufacturing, and distribution processes of your devices.
- Clinical investigations: If planning clinical investigations, adhere to specific requirements including obtaining ethics committee approval and informed consent from participants.
- Clinical evaluation: Conduct a thorough clinical evaluation to demonstrate the device’s safety and performance. Compile clinical data that supports the device’s benefits and risks.
In addition to these core EU MDR requirements, the Annex XVI common specification includes seven annexes addressing additional, detailed requirements for non-medical purpose products. These specifications focus on risk management activities in addition to those specified in the MDR, as well as labeling and safety information (e.g. IFU) requirements.
Annex 1 of the common specification addresses general risk management requirements that apply to all six product groups. The subsequent annexes describe risk management, labeling, and safety information requirements for the individual product types. These requirements are highly prescriptive (e.g., specific phrases and wording that should be included on labeling and in IFU), depending on your product’s characteristics. The directions in your product’s relevant annex should be reviewed and followed closely.
Something to keep in mind – your Notified Body may have very specific requirements for your technical documentation related to an Annex XVI device. For example, they may have certain expectations for the content of the clinical evaluation related to the non-medical intended purposes of your device. You should discuss this topic with your Notified Body to make sure you understand their specific expectations for your Annex XVI device technical documentation.
Transition Timelines for Annex XVI Products in the EU
The EU MDR is already in force, but some transition deadlines for purely Annex XVI products are still years away. The transition timing requirements are a bit of a puzzle so you need to review them carefully. You need to consider factors like clinical investigation needs, planned significant changes to your product, and whether you need to work with a Notified Body. Another thing to consider – if your device has both medical and non-medical intended purposes, you need to abide by the transition deadlines for a full medical device. In all of these scenarios, manufacturers of all devices should take full advantage of the transition timelines and start work now, especially if this will be your first time complying with a medical device regulatory framework
Per Regulations 2022/2346 and 2023/1194, transition deadline requirements for non-medical-purpose products vary depending on a number of factors, including your device’s risk classification (refer to EU 2022/2347 and EU MDR, Annex VIII for classification rules). Your device classification determines the conformity assessment route (i.e., the regulatory requirements you must fulfill to obtain a CE Mark certificate for your product). Your conformity assessment route could include steps like a clinical investigation or Notified Body involvement, two criteria that will add time to your transition timeline.
While you should confirm the transition deadline for your specific device, transition deadlines for Annex XVI products are primarily dictated by whether you must perform a clinical investigation:
|Place on the market or
put into service until …
|December 31, 2029||
|December 31, 2028||
However, timing matters when it comes to placing your product on the market. EU regulators want manufacturers to show they are working toward compliance as these timelines draw near. For instance, if your product requires a clinical investigation and you decide to place it on the market between December 2024 until December 2027, your clinical investigation must already be underway. Later market entry points require you to be further along in the compliance process.
For products requiring a clinical investigation:
|Market entry period||Requirements|
|June 22, 2024 until December 22, 2024||“[R]eceived from the Member State concerned a notification, in accordance with Article 70(1) or (3) of Regulation (EU) 2017/745, confirming that the application for the clinical investigation of the product is complete and that the clinical investigation falls within the scope of the Regulation (EU) 2017/745.”|
|December 23, 2024 until December 31, 2027||“[S]ponsor has started the clinical investigation.”|
|January 1, 2028 until December 31, 2029||“[W]ritten agreement for the performance of the conformity assessment has been signed by the notified body and the manufacturer in accordance with Section 4.3, second subparagraph, of Annex VII to Regulation EU) 2017/745.”|
For products not requiring clinical investigation:
|Market entry period||Requirements|
|January 1, 2027 until December 31, 2028||“[W]ritten agreement for the performance of the conformity assessment has been signed by the notified body and the manufacturer in accordance with Section 4.3, second subparagraph, of Annex VII to Regulation (EU) 2017/745.”|
Ready to Learn More?
Nonmedical intended purpose devices don’t fit neatly into most regulators’ definitions of a medical device. It can be difficult to determine your regulatory obligations and the timing requirements for meeting them, especially if you aren’t familiar with how medical device requirements apply to aesthetic products. If you’re marketing a device without an intended medical purpose, our experienced consultants can help you determine your regulatory requirements in the EU or any of the other global markets. We’ll help you with all aspects of EU MDR compliance as well as ensure that your quality management system meets relevant requirements in these markets.