Regulation Timeline

May 2020

The date of applicability is May 26, 2020. You must prioritize work on your QMS. This is the deadline for Class 1, Class 1R, and Class III Custom devices.

May 2021

May 26, 2021: All periodic safety update reports for MDD and MDR compliant devices must be completed.

Dec. 2021

18 months from initial date of applicability, all MDD and MDR compliant devices must be registered with the European database on medical devices (EUDAMED).

May 2022

May 26, 2022 is the IVDR date of applicability.

Will you be ready?

Impact of changes

Regulation of medical devices in Europe has been remained relatively unchanged since the 1990's. However, recent crises in the medical device industry have brought to light the need for new medical device regulations. These reforms were applied in the new EU Medical Device Regulation, entered into force in 2017, with mandatory adoption for all medical device companies.

The EU medical device regulation changes were created to ensure medical device companies maintain a high standard of quality in an effort to avoid any further failures or serious recalls. Moving forward with these revisions, all medical devices will require a safety and performance audit before they can be marketed in the EU.

Medical devices will also be required to provide patients significantly greater transparency regarding the benefits and risks of the products, and will be required to complete a risk/benefit ratio assessment.

The impact of these changes will be seen throughout the entirety of a company. If compliance is not met by the outlined time, companies can face fines, recalls, import bans, or revoked licenses.

R&Q will work closely with your company to provide you with strategic and implementation tools and support to efficiently and effectively ensure EU MDR compliance.

We do it all... or only what you need

1

EU MDR Impact assessment

High-level examination of all items with significant impact in the EU MDR. Up-classifications, lack of clinical evidence, own-brand labeling, QMS impact, economic operators, UDI, new testing requirements, and more…  

2

Foundation for alignment

Built based on the results of your impact assessment and includes a project charter and client-specific training program. It also includes a preliminary program plan, schedule, and budget.

3

DEEP DIVE GAP ASSESSMENTS

Conduct gap assessment of every regulatory file (tech files and dossiers) or until consistent themes are identified to enable remediation planning. Then, gap to all elements of the MDR. There is much more to this step! Contact us.

4

PLANS BASED ON WORKSTREAM

Plans developed include a regulatory impact plan which aligns your portfolio to MDD and MDR certification timelines (and more), quality plan for managing QMS changes, and an overall program management plan and schedule.

5

EXECUTE PLANS TO completion

This includes effective program management and regulatory intelligence monitoring. Other critical aspects include establishing a program governance process to efficiently resolve questions and issues in a timely fashion. KPI’s are monitored and reported up effectively on all workstreams.  

Frequently asked questions

  • The transition period doesn’t end until May 2020. Why start now?

    2020 is not far away. Given the extensive amount of work that must happen between now and then, if you don’t start now, you won’t finish. The resources of the notified body and lead times will not be available. The closer to the 2020 date, the longer we’d expect the lead times to be...if you can even get the support. At the minimum, you must execute your plan and understand how big of a gap you have to fill between now and then. At least then you’ll know if your products are in good shape with only minor tweaks to make. Hitting that date will be impossible if the plan isn’t started today.

  • Can you provide any guidance on what is needed for State of the Art?

    The state of the art should include a summary of the clinical background for the corresponding medical field, a description of the medical alternatives available to the patient population, a summary of the applicable standards and guidance documents, and a conclusion regarding the subject device compared to the state of the art. The clinical background summary will include details on the medical condition, users, and patient populations. The description of the medical alternatives should include data on the safety and performance of benchmark/similar devices and alternative therapies as well as a summary of the advantages/disadvantages and benefits/risks of those alternatives. The state of the art should be supported by literature references identified through a systematic literature search. The amount of detail included in a state of the art is usually proportional to the complexity and risk of the device.

  • What is a 1R device?

    These are reusable devices.  This is a new classification and requires NB involvement, much like class I devices with a measuring function. The NB oversight is focused on activities such as sterilization between uses.

  • Can you give examples of minimal changes that would not trigger a need to move to MDR?

    This is a tough question as it will vary based on the risk class of the device and should really be discussed with your Notified body.  Some manufactures use a decision tree similar to the FDA decision tree for submitting 510(k)s to determine if a change is significant or not.   This doesn’t encompass everything that should be considered, but may be a good place to start.

  • What type of testing would be expected for disposal of devices?

    Safe disposal testing will vary based on the type of device.  Testing may include tests like validation of the cleaning or decontamination instructions for the device, verification of disposal method (i.e. can the device be incinerated?), or verification of safe disassembly instructions if device must be taken apart for disposal. 

  • What is / Is there a best way to map the EU-MDR regulation changes onto the stages in the manufacturing Life Cycle of Medical devices?

    We would say that there is not one best way. The MDR does have specific sections, but none identified as just applicable to manufacturing. For manufacturing, I would consider starting with requirements from Article 10 Section 9 (QMS), Annex I (GSPR) and Annex IX (Conformity Assessment).  Article 10 (9) and Annex IX will cover the most of the QMS requirements like Management reviews, CAPAs, Non-conformances, verification, complaints, etc., which may impact your manufacturing processes. Annex I will cover requirements like Risk and Manufacturing plans and validations which will be required and may impact the manufacturing lifecycle.

  • Are there any new requirements from a risk management documentation perspective?

    Yes, there is a requirement for a risk management plan that we have heard is more product specific than how it was utilized in the past.Additionally, it is expected that risk management is tied more closely with PMS activities. As such, if you have not done quantitative risk analysis in the past, it will be needed now.  =You will also have to update with real data on a more frequent basis depending on the classification of your device and how often you are creating PSURs or PMS Reports.

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