Remember that (as you probably know), medical device accessories are regulated in the EU in the same way as medical devices. In fact, medical devices and their accessories are deliberately and simply just called "devices" by both Directive 93/42/EEC and Regulation 2017/745. The point being that, if we're pondering the European conformity assessment requirements for medical device accessories, then we need to apply the same conformity assessment paradigms that we would apply for medical devices.
Therefore, as a general rule, Notified Bodies will expect transit testing for sterile accessories of medical devices. Remember that transit validation is an essence of the European harmonized sterile packaging standard EN ISO 11607-1:2009 (see clause 5.5 and the referenced transit validation standards such as ASTM D4169 listed in ISO 11607-1's Annex B). Accordingly, it will almost automatically be an uphill battle to try and waive transit testing for a sterile device, even if in Class I.
However, in the possible event that the sterility of the Class I device is not actually necessary for assuring safety and performance in your intended use, then transit testing could foreseeably be waived via risk analysis. For example, if the accessories are off-the-shelf items that happen to be sterile, but where the sterility is not actually germane to your particular intended use, then that could be a candidate for risk-based waiver of transit testing.
Best regards,
Kevin
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com© Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 12-Apr-2019 11:30
From: Pooja Rathor
Subject: Shipping validation
Hello Randall,
Thank you for your feedback. I have a follow up question.
Our Class IIa device is a non-sterile device however the 2 accessories that go with it are Class I Sterile..We have shipping validations for our Class IIa device.Would we need it for our accessories too??? Or can we just provide a Rationale for not including them??
Thank you.
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United States
Original Message:
Sent: 12-Apr-2019 11:21
From: Kevin Randall
Subject: Shipping validation
As a general rule, the Notified Body will typically require that shipping validation be performed to demonstrate conformity with Directive 93/42/EEC Essential Requirement #5 and new Regulation 2017/745 General Safety and Performance Requirement #7. This will most definitely be the case (no pun intended) for the sterile class IIa devices. For the non-sterile class IIa devices (or, for that matter, any other medical device), if shipping validation is not performed, then a defensible line item(s) would be needed in the product's risk analysis.
Hope this helps,
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
© Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 12-Apr-2019 09:43
From: Pooja Rathor
Subject: Shipping validation
Hello ,
I would appreciate if someone could advice me on the following:
Is Shipping validation a requirement during a Technical file review? We are in the process of sending documents to our NB for a technical file review for our Class IIa sterile/non sterile products.
Thank you.
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United States
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