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The Medical Device Industry has always been one of the most demanding when it comes to satisfying its stakeholders.

Satisfying and embracing the needs of multiple actors (market evolution, patient safety, investors, regulators and supply chains) has obligated Legal Manufacturers of medical devices to adapt to change in order to remain viable and in demand. 

Notified Body Medical Device Certification AuditNowadays, we see that the frequency of change has picked up and the impact can be considerably stronger.

Many medical device manufacturers have been alternating suppliers and subcontractors to meet their supply or quality needs. Others are analyzing the upcoming changes of regulations and standards (MDSAP, MDR and IVDR, ISO 13485…etc.) to prepare for a smooth transition and safe landing. Some are looking to consolidate sites and activities while others are adopting new technologies (3D printing, cloud data management, nanotechnology…etc.).

With all of the above moving targets, communication and involvement of all interested parties is crucial. Today we will focus on one communication aspect that can make or break a medical devices successful journey to market…..that is the Change Notification to your Notified Body. LNE/G-MED in this edition of the March newsletter touches on the common changes that need to be communicated to your Notified Body and when the change or change plan should ideally be communicated.

Define Change

So what is Change? Let’s start simple: Change in its abstract definition is the process of causing a function, practice, or something to become different compared to what it is at present or what it was in the past. Keeping in mind that this definition applies to legal manufacturers and all of the actors involved in its supply chain (suppliers, component manufacturers, etc.).

For the Medical Device Industry, changes can be split into two categories:

  • Significant / Substantial changes
  • Minor changes

You can also refer to the Recommendation NB-MED/2.5.2/Rec2, which explains the practicality issue of identifying the significant changes: “it is not practicable to specify in general terms what types of change are or are not “substantial”. For instance, a change in colour may be purely cosmetic in some cases, yet be “substantial in other cases e.g. where it is the means for drawing attention to warnings, functions etc.

Report Change

Notified bodies have always challenged Medical Device Manufacturers to report changes to products already on the market, changes to the certified Quality System or Design changes allowing new variants to access the market. However, the intensity of this “challenge” varies from one device class to another and one market access to another. This process varies from an annual audit practice (for lower risk devices) for a Notified Body to assess the changes during audits to a more frequent and time sensitive process for devices under EC Design Examination or Type Examination.

Unfortunately and to this day, there is no one size fits all diagram or decision tree for Medical Device Manufacturers and Notified Bodies to apply across the board, it is a risk based approach and impact analysis that needs to be equally considered by the Manufacturer and the Notified Body in assessing the change and making sure the end product answers to the safety and performance requirements and fulfil the Essential Requirements applicable to the products. The good news is that this risk based approach allows more flexibility and creativity as long as all involved parties understand the concept and place compliance as a paramount goal.

Indeed, we can elaborate and provide an indefinite number of examples for each medical field, process, material and indication. It is highly recommended that manufacturers consider the following when planning for a change notice (specifically for CE marked products):

  1. The EU directive and annex applicable to your device(s)
  2. The certification service contract signed between you and your Notified Body (i.e. articles on responsibility of manufacturer)
  3. Guidance documents that help you navigate the different cases of change, for example:
  • The Recommendation NB-MED/2.5.2/Rec2 discusses the Reporting of design changes and changes of the quality system. The NB MED guidance document has not been ratified by the EU commission however it provides a fair level of details to help understand and how to approach your notified body when considering changes.
  • NBOG Best Practice Guide 2014-3 takes a look at definitions of changes, steps manufacturers can take to assess and report changes, types of changes (product, QMS, product range, specific cases…etc.) and many examples of changes and what can be considered substantial in one case and minor in another.

Roles

The Manufacturer should establish, maintain and apply a tailored procedure for categorizing, documenting and implementing changes (to its products and/or quality system) and informing its Notified Body as needed.

The Notified body should have a well-established mechanism in order to:

  1. To decide whether the changed Quality System still fulfils the requirements of the respective conformity assessment
  2. To assess whether change(s) could affect the fulfilment of Essential Requirements by the devices manufactured under the quality system.
  3. Provide the Manufacturer of its assessment decision.

Easier said than done, in particular when Manufacturers race the clock to access the market or meet a client/patient’s need. Your Notified Body needs to meet its regulatory obligations but also provide the resources and turn-around time that meets your business needs.

Common Changes

The table below shows the most popular changes implemented by Medical Device Manufacturers. It is a sample list that can give you an idea of timelines. The most restrictive change notices (EC Design Examination / EC Type Examination certification) are not included. However, for any questions related to the timelines and what to report, please contact your certification project manager to provide more details.

Examples*

When to report change/plan**

(-in advance)

Example of main information to report***

Change in Labeling/IFU

Average 2 weeks

Reasons for change, impact on indication and contraindication, drafts

EU rep change

Contract, name address of EU representative, draft labeling

Addition of product variant

Average 1 month

Medical Device commercial reference – Classification Declaration of Conformity (DoC) – Instructions for Use ( IFU) – Labeling – Manufacturing sites involved – Design phases completion (MDD)

Addition of site

On a case-by-case basis

Updated Quality Manual (QM), organizational chart, activities split, extension plan, employee count.

Supplier change

On a case-by-case basis

Agreement, impact on products, certifications, transition plan.

Withdrawal of device,  Reduction of scope activity

Average 1 month

Device – reasons (recall, complaints log…) – last batch ID…etc.

Merger – Change of legal entity

Average 2 months

Updated Quality Manual (QM), organizational chart, employee count, official registrations, new entity name…

Name change

Registration, updated Quality Manual (QM), technical documentation, labeling, IFU…

Addition of product line

2-3 months

IQ,OQ,PQ validation timeline – scope changes – suppliers changes - Instructions for Use ( IFUs)

Relocation

Updated Quality Manual (QM), organizational chart, activities split, relocation plan, validation plan, employee count, labeling..

Transition to new standard

4+ month

Transition plan - timeline

*Non-exhaustive list and does not serve as a reference of changes to be reported to your notified body. It is the manufacturer’s responsibility to assess the significance of change and the reporting mechanism. The list is in alphabetical order and does not represent the risk or significance order.
** Ideal timeframe, please contact your Project Manager for timelines specific to your company and change. The durations mentioned estimates that include: assessment of change significance, assessment duration, decision processing.
*** This is the preliminary information needed to assess the structure of review/audit. Additional information will be requested throughout the review/audit process.

Assessment of change

Following the notification of change, the Notified Body will propose the appropriate assessment structure, timeline and cost; the structure can be one or a combination of the following assessment depending on the certification route / standard and the impact of this change:

  1. Onsite audit
  2. Offsite audit
  3. Offsite/Documentary review
  4. EC Design Examination / EC Type Examination
  5. Competent Authority Consultation

Note: If your change falls within the timeframe of your annual audit, please provide the information as part of the audit preparation documents. The change will most likely lead to an adjustment to the audit planning/program.

Common Pitfalls

lne gmed arrow Pitfall: Implementing significant change prior to Notified Body approval.

Possible Cause: Considering the change as minor, missing Notified Body notification

Possible consequence: Major nonconformity, Suspension of certification / product recall

 

lne gmed arrow Pitfall: Report changes during the annual or unannounced audit

Possible Cause: Avoiding additional review/audit

Possible consequence: Major nonconformity and additional audit, delay in change approval

 

lne gmed arrow Pitfall: Report changes during the renewal audit

Possible Cause: Change was implemented very close to audit date

Possible consequence: Delay in change approval / renewal, major non conformity and additional audit

 

lne gmed arrow Pitfall: Failure to forecast range extension

Possible Cause: Urgent client change order

Possible consequence: Delay in processing change by Notified Body, delay to market

 

lne gmed arrow Pitfall: Failure to report change in critical suppliers processes/Quality Management System (QMS)

Possible Cause: Manufacturer believes it’s not under his role to report

Possible consequence: Major non conformity, supplier audit (additional), delay in change approval

 

As you can see, there can be a lot to lose when missing this vital communication step. Make sure your Notified Body is abreast of all upcoming changes. If you are in doubt, don’t hesitate to contact your Certification Project Manager (CPM) and explain the case. Reach out to you Production Coordinator (PC) and ask for the most recent change notice form.

If you are in the process to prepare your change notice, and want to know more about the process, timelines and information to provide, we invite you to join us for our upcoming free webinar on this topic March 29th, 2017.

 


LNE DOWNLOAD PDF  Download this newsletter in pdf format here.

 

About the Writer
Ehab Amen LNE Gmed

Ehab Amen
Production Director at LNE/G-MED North America, Inc.
Ehab Amen is the Production Director at LNE/G-MED North America Inc. and brings more than 11 years of process improvement, business solutions and resource optimization experience to the organization. With his Engineering background and management skills; Ehab leads a team of dedicated production coordinators aiming to increase process visibility, process flow and cost effectiveness to our clients.

 

WEBINAR REGISTRATION
Calendar Notified Body 03 29

Topic: Notification of change: How, when and what to communicate with your Notified Body?
Date: Wednesday, March 29th, 2017
Time: 2:00 - 2:30 PM Eastern Standard Time

Presenter: Ehab Amen, Production Director for LNE/G-MED North America, Inc. 
Click here to Register!

 

 

 

 

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