Begin with the End in Mind: This is the second habit Steven Covey lays out in his famous book, The Seven Habits of Highly Effective Sales Leaders.
The reason this habit is so important is that it aligns all tasks, projects, and talent toward a single purpose. This habit also provides a framework to eliminate tasks and projects that will not help accomplish the end goal.
With major regulatory shifts occurring in the medical device industry it is imperative that device manufacturers know exactly which “end” to keep in mind. Falling out of compliance with these new regulations comes with a tough consequence: your device may be pulled from the market.
When it comes to staying compliant with MDSAP, MEDDEV, ISO 13485:2016 or MDR, resources are going to be constrained across the board. Audit times are increasing, Notified Bodies are swamped or are closing, access to talent is becoming more scarce, the timeline is tight, and there is a lot of competition. It is vital that you manage medical device compliance projects as efficiently as possible.
So, Where to Start?
In simple terms, a Gap Analysis is needed. Create a comparison document between the current state of compliance and the required future state of compliance. This analysis will identify which compliance requirements are already being met and which ones the product fails to comply with. This gives a clear “end” to which the team can focus. Anything which does not align with these goals must be eliminated to best maintain efficiency.
Once the Gap Analysis is complete, identify the new regulations to comply with and create a list of changes from the previous regulatory standards. Also consider the regulatory impact changes will have on the product under each particular governing country.
With standards changing in Europe, Canada, Asia, and Australia, there may be overlap in regulations. This may enable reuse of some work for multiple regulatory bodies. Dig into and understand what documentation standards you will need to meet. Streamline this process by compiling a list of clinical trials, testing standards, and post-market surveillance to compare against new requirements.
Connect with your Notified Body.
Some Notified Bodies no longer exist and you may need to find a replacement. If yours is still operating, find out where each of your products are in their queue.
Find the Talent.
Begin identifying the talent and resources needed, and when, for this project. With all the competition for talent, it may take extra time to secure the right people on the best timeline. Both the timeline for available talent as well as placement in the queue for the Notified Bodies will require quality project management skills.
Make sure your project is ready when those resources are allocated to you.
The stakes are high and you have a lot on your plate.
If you are concerned about the upcoming medical device compliancy changes, the time to act is now. A Gap Analysis from the experienced team at Waddell Group will get you pointed in the right direction. We work with companies to perform gap analyses for medical device compliance, help maintain compliance, and manage the projects that spin out of these compliance initiatives.
See how we can help you!
The Notified Bodies are already very busy and our medical device manufacturing clients are already seeing increased audit times. Several European Notified Bodies are no longer taking new clients with the onset of MDSAP (inclusive of ISO13485:2016), MEDDEV 2.7.1 Rev. 4 & MDR. This is the beginning of a 3 year debacle for medical device companies.
These substantial regulatory reforms are now underway and will be required over the next 3-5 years:
MDSAP will become the mandatory replacement for the CMDCAS certification to support Canadian device approvals on January 1, 2019
This is only 3 months before the end of the ISO 13485 transition. The timing is unfortunate, so starting that process now is a necessity.
NOTE: Europe will likely also have joined the MDSAP program, making additional effort for the notified bodies. Brazil, Japan, Canada & Australia are currently a part of this common audit.
The ISO 13485:2016 transition will occur between March 1, 2016 to March 1, 2019
Issue of new certificates to ISO 13485:2003 are no longer permitted or almost impossible to get (but expire March 1, 2019), and those seeking new certification after March 1, 2018 must be to the 2016 version of the standard.
MEDDEV 2.7.1 Rev 4
Update from Rev 3 includes these significant items:
- Clause 6.4 introduces specific requirements for expertise & experience of CER authors / evaluators
- Revision 4 makes the requirement for the objectives of the CER to be linked to specific safety, performance and risk-benefit endpoints clearer
- Clause 8.2 provides more detail with respect to establishing and documenting the state of the art and available treatment options
- The new revision places much greater emphasis on demonstrating the scientific validity of data, including statistical considerations
- Appendix 2 describes key considerations relating to device risk and how manufacturers should determine if they have sufficient clinical evidence
- Appendix 7 provides guidance on the analysis of data to demonstrate device safety and performance
- The links between clinical evaluations, PMS and PMCF are reinforced. Appendix 12 highlights the requirement for Notified Bodies to ensure that PMCF is planned and appropriately justified in light of the data retrieved and conclusions documented in the CER
MDR has been approved and published as of May 5, 2017 (enforceable May 26, 2017)
This kicks off a 3 year transition for medical devices ending in early May 26, 2020 (the IVD regulation has a 4 year transition).
Notified Bodies must become accredited to the new regulations and it won’t actually be possible to start issuing certificates to the new regulations until early 2018.
The European Union is already considering granting grace periods to medical device manufacturers whose current certificates expire in the middle of the MDSAP transition, in case the Notified Bodies are not yet qualified to certify to the new regulations. Your medical devices may also be reclassified under this new standard to require more vigorous standards.
What does this all mean to medical device manufacturers?
It’s going to be unbelievably busy over the next two years.
By then, the European Notified Bodies especially will be trying to deal with CE and ISO 13485 transitions at the same time, while also meeting the higher assessment standards under the new regulations. Their international (especially North American) divisions are going to be in the thick of MDSAP audits as well as ISO 13485 transitions.
The four big questions you need to ask are:
- What devices do you need to prioritize?
- Have you performed a gap analysis to help you decide what you need to do?
- How long will it take you?
- What resources will be required to recertify?
With the expected reduction of the number of Notified Bodies in Europe, there will be a backlog. You need to get started as early as you can to make sure you recertify inside the required window.
Deciding which devices to prioritize, providing an accurate scope of your medical device compliance project, and constructing a plan to make sure your recertification happens on time and on budget. Waddell Group is here to make you more efficient and effective.
Our project managers are familiar with the regulation changes reviewed above, and are eager to help your company with preparation of changes.
Call us today to learn how we can help your company through this transition!