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:

1. What devices do you need to prioritize?
2. Have you performed a gap analysis to help you decide what you need to do?
3. How long will it take you?
4. 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!

Tom Waddell: 952-221-3333 | [email protected]
Chuck Gilbertson: 612-275-0602 | [email protected]