Special authorizations for medical devices: Last resort for manufacturers?

Special authorizations are a concept of the MDR (Article 59). In this way, the legislator wants to create a possibility to place medical devices on the market in emergency or exceptional cases, even without having gone through a complete or successful conformity assessment procedure.

The provisions of article 59 should not be confused with concessions and exemptions under Article 97.

1. The concept of special authorizations

a) Term

The MDR does not use the term "special authorization.” But it creates a concept in Article 59 that corresponds to a special authorization. It calls it "derogation from the conformity assessment procedures.”

Article 59 of the MDR allows competent authorities to authorize the placing on the market of a medical device without a regular conformity assessment procedure having been carried out. This means that placing on the market without CE marking is allowed.

b) Objective of the legislator

In this way, the legislator wants to create an opportunity to ensure the availability of medical devices in emergency situations, e.g., when there is an urgent medical need that cannot be met in the short term. This is intended to counteract any supply bottlenecks that may occur in the case of urgently needed medical devices. One example was the corona self-tests during the pandemic.

Similar procedures exist in other countries, such as the FDA's "Emergency Use Authorization.”

c) Delimitations

Concessions, special authorizations and Article 97 exemptions differ in various aspects.

d) Distinction from the "concession"

Special authorizations and concessions must not be confused.

A concession is a term from ISO 13485. Concessions provide the framework for how manufacturers deal with non-conforming devices, especially prior to shipment.

This is about devices that do not meet their specifications. These can be harmless defects, such as a blemish on the paint, or something that affects the safety or effectiveness of the devices, such as faulty sterilization before delivery.

Through a concession, manufacturers are allowed to place devices with nonconformities on the market in justified cases. The prerequisite is that the safety and effectiveness of the device are not impaired. Thus, a concession in the case of faulty sterilization could most probably not being justified.

e) Distinction from "Article 97 exemption"

Also, not to be confused with special authorizations are devices that are allowed to remain on the market under Article 97 of the MDR.

Procedure of the authority

This Article 97 provides the competent authorities with the authority for market surveillance of devices already placed on the market.

If an authority finds that a device is not in conformity with the MDR, it may request that the non-conformity be remedied. In order to do so, the authority must conduct an assessment under Article 94.

If the authority concludes that the device does not pose an unacceptable risk to health, even if the MDR is not fully complied with, it may set a deadline for remedying the non-conformity in accordance with Article 97.

Application of Article 97 in the case of MDR transition periods

This procedure is currently under discussion in connection with the transition periods from MDD to MDR:

The MDCG proposes in the revised Guideline 2022-18 to benefit from Article 97 in case an old MDD certificate expires before obtaining an MDR certificate, and thus a non-conformity exists.

The new transitional provisions also explicitly mention Article 97. Accordingly, authorities should use Article 97 in those cases where the MDD certificate expires or has expired before the new transitional provisions come into force.

2. Validity of special authorizations

Back to the actual topic, the special authorizations:

Based on Article 59 MDR, the member states regulate the details for the implementation of the special authorization in their national laws. In Germany, Section 7 (1) of the MPDG is relevant. This regulatory framework allows for special marketing authorizations if there is a situation of need.

Step 1: Application by the manufacturer

The manufacturer must sufficiently justify this need in his application to the authorities. In Germany, this authority is usually the Federal Institute for Drugs and Medical Devices (BfArM) or, in the case of certain IVD devices, the Federal Institute for Pharmaceutical Information (PEI).

The manufacturers submit the application informally to BfArM. It should contain information on the device and a justification for the need for special authorization. In addition, the authority will require evidence of the safety and effectiveness of the device.

Step 2: Inspection by the authority

The authority then evaluates whether a corresponding supply shortage actually exists and whether the device is urgently needed for healthcare. In doing so, it also evaluates whether there are alternative devices on the market. It will certainly also check whether the device or similar products pose serious health risks. To do this, it will refer to information from market surveillance.

Step 3: Approval by the authority

In the positive case, the authority issues a special authorization, which is usually limited in time.

The exact timeframes for the decision-making process and its announcement are not specified. In the corona pandemic, this was achieved within a few weeks.

Step 4: Information of the other member countries by the authority

The national authority then informs the EU Commission and the other member states.

3. Pitfalls that manufacturers should avoid

a) Approval is only valid nationally

Special authorizations are only valid nationally, i.e., in the respective member state in which the manufacturer has requested it. Placing on the market in other EU member states is in general not possible.

However, in exceptional cases related to public health, patient safety, or patient health, the Commission may authorize placing on the market throughout the EU area by means of implementing acts.

These exceptional authorizations are also limited in time. In addition, the EU defines the conditions under which the device may be placed on the market or put into service.

b) Free trade certificates are not possible

Devices benefiting from the special authorization are not allowed to carry the CE marking. This is also relevant because that is why the authorities usually do not issue certificates of free sale for third countries.

c) Evidence on safety and performance to be provided

However, the special authorization does not mean that the manufacturers must not prove that their devices are safe and effective. Even in this case, manufacturers should comply with the relevant (harmonized) standards.

The authorities request evidence of fulfillment of applicable safety and performance requirements. However, they may waive selected ones, if necessary, as well as the successful completion of the overall conformity assessment procedure. Because otherwise, "regular" placing on the market would be possible.

d) Special authorizations cost money

The authorities charge money for processing. In Germany, the costs range from 250 to 10,300 euros, as specified in BMGBGebV Section 10.

4. Summary and Conclusion

a) Advantages and disadvantages

The different procedures have their respective advantages and disadvantages.

Advantages of the Article 97 exemption

Proceeding under Article 97 offers advantages over the special authorization:

• The exemption has a higher chance of success.
• There is no restriction to one member state.
• The devices may continue to bear the CE mark.
• This also allows the issuance of free sale certificates.
• The manufacturers do not have to justify a supply shortage.

It is recommended to apply for this exemption if "only" the certificate has expired.

Advantages of the special authorizations according to Article 59

The special authorizations according to Article 59 offer other advantages:

• The devices do not have to have already undergone a conformity assessment procedure and do not require CE marking.
• This even allows placing on the market without the involvement of a notified body.

In general, the chances of a special authorizations are considered low, unless there is a pandemic situation or the devices in question are highly specialized niche products and without alternatives.

b) The "right" way

Which way manufacturers should choose to market their devices beyond the normal procedures depends on many parameters:

• Type of device
• Target market
• Existence of a CE mark
• Timeframe available for placing on the market