Although the MDR took effect in May 2021, it is providing the industry with a soft transition period from the Medical Device Directive.^[1] This means that products already certified under the previous MDD directive, can be marketed in the EU until 2027 / 2028 giving a few conditions, like no significant design specification change for example.

To support manufacturers in their transition to MDR and to place new devices on the EU market, we developed a plan to analyze the gaps and assess the required actions to achieve compliance with MDR.

Our Eight-Steps plan includes MDR analysis, impact assessment and implementation of the processes:

With this plan, we can determine the priorities for initiating the critical action items on time leading the extensive effort to be manageable and attainable.

Analysis Phase

STEP 1: Comprehension of the MDR requirements at the company level

We are starting by reviewing the company quality system, to conduct a comprehensive gap assessment and identify the required steps to achieve compliance with MDR, considering the type of device and its regulatory status (legacy devices, or devices never placed on the EU market).

During this step, we are reviewing company procedures to assess compliance of the whole quality system with the MDR (and CFR 820 and other when relevant) requirements.

Impact assessment Phase

STEP 2: Perform impact of the gap assessment covering both the QMS and the Product. This impact assessment helps the company to capture and evaluate the impacts of the MDR on the company quality system (QMS) and product performance. The impact assessment includes adjustment of the company Standard Operating Procedures (SOP) to comply with MDR requirements (revision of existing SOP or creation of new SOP) and conducting internal audit per company divisions. This includes the design processes, QMS main processes and clinical processes.

During this step, we are reviewing the technical documentation, to understand and map the efforts and resources needed to prepare a good and appropriate technical documentation.

STEP 3: Prepare Master remediation plan including resources planning

Next step, once all gaps are identified and mapped, we are generating a master remediation and resource planning with the required resources (subcontractors, employees, out-sourced consultation), budget planning and estimated timeline.

STEP 4: Prepare detailed remediation and implementation plan per division

Based on the master remediation plan, each division within the company can prepare a detailed implementation plan per activity and determine the priorities according to specific remedy.

Implementation Phase

STEP 5: Company regulatory training on MDR implications

We will prepare and execute an annual training program designated for MDR implementation. This plan will include at least the following subjects:

• QMS
• Design control
• Risk management
• Usability
• Device classification and technical documentation
• Clinical evaluation
• Post-Market Surveillance (PMS) 
• EUDAMED
• Economic operators
• UDI

STEP 6: Compliance effort

During this step, each division will carry out the necessary activities in accordance with the master plan for implementation. The remediation will be divided into two:

1. Efforts to remediate QMS gaps.
2. Remediate and generate the Technical Documentation (TD)

STEP 7: Specific trainings for each division

At this step, training sessions on MDR implications per division for new procedures and modified processes are conducted.

STEP 8: Effectiveness evaluation by audits

Finally, at the end of this process, internal audits will allow a complete evaluation of the implementation and effectiveness of the plan.

[1] According to MDR 2017/745 (as amended by regulation 2020/561 and regulation 2023/607) Article 120 paragraph 2-6.

The FDA Breakthrough Device Designation is a formal identification by the US FDA that a device in development should be expedited for patient access because it has a reasonable chance of providing more effective treatment than the standard of care for the treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.

What does it offers?

1. Catchy name 
2. The Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission.

Am I suitable for breakthrough designation?

To be granted breakthrough status, your device must also meet at least one of the following four secondary criteria:

1. Represents Breakthrough Technology
2. No Approved or Cleared Alternatives Exist
3. Offers Significant Advantages over Existing Approved or Cleared Alternatives
4. Device Availability is in the Best Interest of Patients

What are the benefits of receiving the designation?

The breakthrough designation helps the FDA identify new technology to focus on in order to expedite access to novel devices that will save lives and treat debilitating diseases. It takes the FDA longer to review these devices because they may raise novel scientific and regulatory issues. Therefore, the FDA prioritizes 510k and De Novo submissions for breakthrough devices over other 510k and De Novo submissions, and the FDA’s senior management is involved in the review process. The average review time for the seventeen 510k cleared breakthrough devices was 155 days*. This may not seem like an expedited review, but the average review time for 510k cleared devices that require additional testing data is almost 270 days. The average review time for the twenty De Novo Classification Requests designated as breakthrough devices was 251 days*. This represents a significant improvement compared to the average De Novo Decision timeline of 338 days for 2019-2022.

*Metrics updated on 10/31/2022 with data through 9/30/2022

Reimbursement

In the past , Breakthrough Device Designation by the FDA also had a benefit concerning reimbursement. Typically new technology is not covered by CMS for the first two years, however, once you receive Breakthrough Device Designation, you receive immediate coverage through CMS until traditional coverage takes effect. 

Why did they stop it?

CMS said that the requirements needed to qualify a device for entry into the breakthrough device program is less than what’s needed for that device’s approval. CMS also expressed concern that the device may not be deemed necessary or safe for Medicare’s patient population.

Mechanisms of Expedited FDA Review

In addition to identifying breakthrough devices for priority review and involving the FDA’s senior management, the FDA also offers four other mechanisms for improving the review time. First, the FDA offers “Sprint discussions.” 

1. A “Sprint” discussion allows the FDA and the company to discuss a single topic and reach an agreement in a set time period (e.g., 45 days). 
2.  A Data Development Plan (DDP) mechanism. the FDA will work with the company to finalize the non-clinical and clinical testing plans for the breakthrough device. 
3. Clinical Protocol Design Agreement. FDA will interactively review changes to clinical protocols rather than conducting a protocol acceptance review first. 
4. Prioritized pre-submission review. If a company prefers to discuss multiple issues in one meeting rather than conducting Sprint discussions on single topics, then the FDA will prioritize pre-submission review. 

How do you apply to the FDA for Breakthrough Designation?

To receive the designation, you must prepare a Breakthrough Device Designation request:

1. Device description 
2. Outlining how your device meets the criteria for breakthrough designation, 
3. Any preliminary clinical data demonstrating the feasibility of the subject device 

No user fees associated with the application for breakthrough designation, and you are not prevented from submitting other types of submissions in parallel with the breakthrough designation request, such as a pre-submission or investigational device exemption (IDE).

When should you apply to the FDA?

If the FDA denies an initial breakthrough designation request, the company may re-submit a request at a later date. Therefore, companies should submit requests as soon as they can provide preliminary clinical data to demonstrate the feasibility of the device’s claimed performance. Therefore, a breakthrough designation request would typically be submitted at the conclusion of an Early Feasibility Study (EFS), which allows a maximum of ten clinical subjects.

How many companies have received Breakthrough Designation from the FDA?

Since the start of the Breakthrough Designation program in 2015, the FDA has granted 728 devices Breakthrough Device Designation*. Only 56 of the breakthrough designations have resulted in market authorization so far. Approximately 16 devices received 510k clearance, 18 De Novo Classification Requests were granted, and 20 PMAs were approved*. Given the number of submissions received each year, only 10-15% of De Novo and PMA submissions are also Breakthrough Devices. In contrast, only about 0.1% of 510k submissions are also Breakthrough Devices.

*Metrics updated on 10/31/2022 with data through 9/30/2022

Lists of devices designated as breakthrough

https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program