The MDCG published a new Position Paper on continued access to the market under MDR Article 97, after an MDD/AIMDD CE certificate expires. MDCG 2022-18 can be found: HERE

This is an exciting new document, as it outlines the mechanism for manufacturers with expiring MDD/AIMDD CE Marking, to continue placing devices onto the market if their devices are not yet MDR CE Marked. This is to act as a bridging measure until the EU legislation is amended to extend the MDR’s compliance deadline.

A legislative amendment will be introduced early next year to postpone the MDR’s compliance date for legacy devices. More information on the Council’s proposed delay to the MDR deadline can be found: HERE

MDCG 2022-18 was published to provide a uniform application of MDR Article 97 throughout Europe. 

What is Article 97?

It is a mechanism for Competent Authorities to allow non-MDR compliant devices to remain on the market if the device “does not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health”.

In this situation, Competent Authorities will require that the device be brought into compliance within a reasonable amount of time. If the device is not brought into compliance within the given timeframe, then the Competent Authority may take measures to restrict or prohibit the device from being made available on the market. This includes requiring a recall of the device if the Competent Authority feels it is warranted.

What is the purpose of MDCG 2022-18?

It is to present a uniform approach to the application of Article 97 among the EU Member States. The MDCG is made up of representatives from the EU Competent Authorities, so this paper presents a common understanding between the 31 regulatory agencies.

What is the MDCG’s Criteria around Article 97?

Article 97 applies to:

• • Products that “are or were” considered to be legacy devices, under the scope of Article 120(3) MDR
  • Devices that are “in transition” from the MDD/AIMDD to the MDR
  • Devices where, despite responsible efforts undertaken by the manufacturer to obtain MDR certification, the conformity process is still pending

Article 97 does not apply to:

• • MDD/AIMDD devices that have been suspended or withdrawn by the Notified Body
  • Legacy devices that have undergone a significant change in design or intended purpose (refer to MDCG 2020-3)

For more information, please read: What are Legacy Devices?

Additional prerequisites:

The manufacturer has made reasonable efforts to transition the device to the MDR, i.e., the manufacturer’s MDR application has already been accepted by a Notified Body, and a written agreement has been signed between the notified body and the manufacturer per MDR, Annex VII, Section 4.3.

However, some good news for small-to-medium sized enterprises. The Competent Authority may waive the above requirement if all of the following conditions have been met:

• • The manufacturer is a small-to-medium size enterprise (SME)
  • The SME’s Notified Body that issued the MDD/AIMDD certificate is not yet designated under the MDR
  • The SME can demonstrate that it has taken reasonable efforts to apply to a considerable number of notified bodies and their application has not been accepted due to lack of capacity
    • The MDCG document does not provide a consensus on what is a ‘considerable number’

Article 97(1) request to Competent Authorities

Manufacturers, or their authorized representatives, should proactively inform their relevant Competent Authority about the upcoming or already incurred non-compliance with the MDR requirements. The request only needs to be made to that Competent Authority, and not to all the national Competent Authorities. 

So that the Competent Authority can make a proper assessment, the manufacturer should submit a report containing relevant data gathered through its post-market surveillance system (PMS), in particular data related to incidents, serious incidents and/or field safety corrective actions.

The Competent Authority should take the following into account, when deciding if the device does or does not present an unacceptable risk to health and safety.

• • Review the above-provided information
  • Additionally perform its own independent research
  • Take into account information from the Notified Body, such as potential safety-related shortcomings identified during the last surveillance audit and their resolution

If the device is determined to not present an unacceptable risk to health and safety, then:

• • Legacy devices are subject to the Article 120(3) transition provision requirements, including compliance with post-market surveillance, vigilance and market surveillance
  • Manufacturers of the eligible Article 97(1) products must further demonstrate that they have adapted their quality management system to the MDR requirements

Criteria and Documents

MDCG 2022-18 includes an Annex with a checklist of the criteria and documents to be provided. This starts on page 7.

The checklist notes which items are optional. For example, each Competent authority could request proof of registration of the device, in accordance with the national requirements. This could be proof of registration for a Class I sterile or measuring device, which must be performed by the manufacturer, or their authorized representative. It could also mean proof of registration for Class IIa, IIb and III/AIMDD devices. This is allowed per the Directives, which states that when the member state transposes the Directive into their national law, they can choose to require registration of those higher-risk devices being placed onto their markets.

If you are unsure which member state requires registration of these higher-risk devices, please refer to our tool: EU Registration Requirements

What is a ‘reasonable period of time’ to get into compliance with the MDR?

The Competent Authorities may decide what they consider a reasonable period of time on a case-by-case basis. Various factors will be taken into consideration, such as the estimated timeframe to complete the MDR conformity assessment process with the Notified Body.

As a general rule, MDCG 2022-18 states the timeframe should not exceed 12 months. However, that it may be extended in justified cases.

Throughout this process, the manufacturer should keep an open line of communication with the Competent Authority regarding any potential delays to the original estimate timeframe.

If the manufacturer does not comply with the timeframe granted, the Competent Authority can take action per Article 97(2), which includes no longer allowing the devices onto the market, up to requiring a recall or withdrawal of the product from the market.

After Article 97(1) is applied to the device

The Competent Authority:

• Will provide written confirmation of this, as well as any conditions and a clear date by which the device must become compliant to the MDR.
  • This communication may be used by the manufacturer to verify that the device has authorization to be placed onto the market, for example, to importers or customs agents.
• Will inform the other Competent Authorities when they have authorized devices under Article 97(1).

The Manufacturer:

• • Is not required to update its labeling, including to the CE Marking.
  • Should inform its distributors and importers about the non-compliance and measures undertaken.
  • May be required to inform its users of the non-conformance and measures undertaken – this will be determined by the Competent Authority.
  • May still obtain Certificates of Free Sale through the compliance deadline outlined by the Competent Authority under Article 97(1).
  • Is not required to pursue additional derogation under Article 59 of the MDR.

The Competent Authority has the right to terminate the authorization under Article 97(1) if new information emerges that the device presents an unacceptable risk to health and safety.

Once MDR CE Marking is achieved

At this time, Article 97(1) will cease to apply, even if the MDR Certification was issued before the timeframe granted under Article 97(1) has been reached.

At that time, the manufacturer should no longer place the non-compliant devices onto the market.

Final thoughts

Overall, it is great to see an established process and consistent application by the Competent Authorities. Certainly, this is needed to ensure continued patient care. The unfortunate byproduct is more work for manufacturers, authorized representatives, notified bodies, and competent authorities to undertake this process.

This is not intended to be a long-term solution. Ultimately, legislative changes are required to prevent a shortage of supply in the European community. Stay tuned for more information about the upcoming proposed delay to the MDR.

For more information, please read: EU Council Supports Postponement of the MDR