You are here: Home / Archives for technical file

CE Marking Process for Medical Devices – A Step by Step Example

August 14, 2012 By Leave a Comment

Thanks again to Rob Packard for providing another guest post. Rob is a Regulatory Affairs and Quality Management System expert whose specialty is helping companies with regulatory submission of a Design Dossiers for CE Marking of high-risk Class III medical devices. You can read more of Rob’s work at QC is Dead and RA Review blogs. 

Thank you for reading my previous posting on Creo Quality, “Canadian Licence Process for Medical Devices – A Step by Step Example” from July 30th. This second posting in the series explains the process for obtaining CE Marking approval for a Medical Device.

For our example, we will be using the same hypothetical client for Jon to help.

Jon’s client called to ask if he could help them expand into the European market. As with the Canadian Market, Europe also considers cyanoacrylate a medical device when it is used as a topical adhesive. Jon’s first step is to determine the device classification as per Annex IX in the Medical Device Directive (93/42/EEC as modified by 2007/47/EC). Instead of relying solely upon the Directive, Jon also uses guidance documents published on the Europa website–specifically MEDDEV 2.4/1 rev 9 (the following link explains the European MEDDEV guidance documents – http://wp.me/p2DThn-1r).

Jon identifies three potential device classifications: 1) Class 1 as per Rule 4 (a non-invasive device which comes into contact with injured skin, if the device is intended to be used as a mechanical barrier, for compression or for absorption of exudates); 2) Class 2a as per Rule 7 (a surgically invasive device intended for short-term use [i.e. - < 30 days] are in Class 2a; and 3) Class 2b as per Rule 8 (an implantable device). These three applications match the three possible applications that Jon identified when he was reviewing Canadian Device licenses.

If this device were not required to be “sterile”, then a Class 1 device could use the Annex VII route of conformity (i.e. – self-declaration). However, even generic bandages are sold as sterile devices. Therefore, whether the device is a sterile Class 1 device or a Class 2a device, obtaining CE Marking approval will still require a Notified Body’s review and approval. The most common route would be the Annex V route of conformity. If Jon’s client were to launch their product as a “glue” for internal use, then the device would require an Annex II.3 Full Quality System Certificate or the combination of an Annex V Certificate and a Type Examination Certificate (i.e. – Annex III).

STOP!

The previous paragraph was hard to understand, but the source of this jargon is Article 11 of the Medical Device Directive. This one section is best practices in European legalese. If you want to make something almost unintelligible, copy Article 11. If you want to understand this stuff, a flow chart of the various routes to conformity is as good as it gets (still hard to understand, but fewer words).

What you need to know…

Jon’s client only has one product family and they are currently selling the product in Canada for external use by healthcare professionals—not as an implant. Therefore, the device is a Class 2a device requiring an Annex V certificate. Jon’s client will need to do the following:

1)      Select a Notified Body

2)      Submit a Technical File for review and approval

Fortunately, Jon’s client already obtained an ISO 13485:2003 certificate with CMDCAS from their current registrar as part of the Canadian Licensing process. Therefore, the changes required for the Quality System consist of adding a few work instructions to meet European-specific requirements, such as vigilance reporting, creating a technical file and performing clinical evaluations. Jon’s client also needs to add the European Requirements as an applicable regulatory requirement in the Quality Manual.

The bigger challenge is assembly of a Technical File for submission. Since the product is already on the market in Canada, all of the technical requirements have been met. The documentation of these requirements now needs to be converted into a format acceptable to a Notified Body. There are three recommended strategies:

  1. What ever the Notified Body prefers. Some of the Notified Bodies have a checklist of requirements for a Technical File. If such a checklist exists, the client should organize the Technical File in exactly the same order.
  2. The GHTF STED format (GHTF/SG1/N011:2008). The Global Harmonization Task Force (www.ghtf.org) published this guidance document in an effort to standardize the format for submission of regulatory submissions. This is the format required for Class 3 and 4 Canadian medical device license applications.
  3. The NB-MED recommended format (NB-MED 2.5.1/rec 5). This document was created by the “Big 5” Notified Bodies. It provides a template in a two-part format for submissions. This is the format I use most often for auditing files and for creating new files.

Jon’s client chose option 3 for organizing their Technical File, because they have full reports for each of the verification and validation tests that were performed, but creating summaries for each report would take longer than assembling a Technical File with copies of each of these full reports.

In all, Jon estimates that his client can complete their preparations in about 60 days. Therefore, Jon suggested that the client obtain a quotation from their registrar for an Annex V Certificate. In addition, Jon suggested hiring a consultant to help them with preparation of a Clinical Evaluation. Prior to 2010, Clinical Evaluations were only required for high-risk devices. As part of the new MDD, clinical evaluations are now required for all devices. Since the use of and risks associated with cyanoacrylates is well characterized in published literature, Jon’s client may use a literature search method for preparing a Clinical Evaluation as per MEDDEV 2.7/1 rev 3.

The company hired an authorized representative to handle European registration, receive customer complaints and to act as a liaison with the Competent Authority in the event of an adverse event. An Authorized Representative Agreement was signed, and the Authorized Representative recommended a few corrections to procedures they reviewed as part of entering the contract with a new client.

The company also hired a regulatory consultant that was able to complete a literature search and write a Clinical Evaluation within 4 weeks. The complete Technical File was assembled and submitted to the Notified Body electronically with 7 weeks of starting the project. The Notified Body’s first round of questions were received within 6 weeks. Jon and the client prepared responses to the questions in a week and submitted them to the Notified Body. Fortunately, the responses were thorough and the Technical File was well-organized from the start. The Notified completed their final review and recommended the product for CE Marking within 3 more weeks. The Notified Body conducted two panel reviews to verify the technical, regulatory and risk aspects of the submission. Finally, the Annex V certificate was received 12 weeks after initial submission of the Technical File.

Filed Under: All, Medical Device - General, Product Development - General, Strategy vs. Tactics Tagged With: , , , , , , ,

Canadian Licence Process for Medical Devices – A Step by Step Example

July 30, 2012 By Leave a Comment

Thanks again to Rob Packard for providing another guest post. Rob is a Regulatory Affairs and Quality Management System expert whose specialty is helping companies with regulatory submission of a Design Dossiers for CE Marking of high-risk Class III medical devices. You can read more of Rob’s work at QC is Dead and RA Review blogs. 

Thank you for reading my previous posting on Creo Quality, “FDA 510(k) or CE Marking?” from July 10th. As an encore performance, I am writing this posting to explain the process for obtaining a Canadian Medical Device License. Why?

Because Canada is easier to obtain approval from than the US FDA or European Notified Bodies.

For my example, I have chosen to invent a client for Jon to help.

Jon just got a call from the makers of Krazy Glue®. They want to start selling their products as medical devices. Fortunately for them, companies have been selling cyanoacrylate (e.g. – Krazy Glue®) as a medical device for years. Therefore, Jon’s client needs to decide if they want to sell the product as: 1) a liquid bandage, 2) a topical adhesive to replace sutures, or 3) a vascular repair device for use inside the body during surgery. Jon’s client indicates that they want to sell cyanoacrylate as a medical device all over the world. Therefore, Jon does a little homework and decides that a “topical adhesive” application will give his client the higher margins of a medical device for prescription use, but it will also avoid the costly pre-market approval (PMA) process at the FDA. Jon also decides to recommend that his client try a pilot launch in Canada first to evaluate their new packaging ideas on a smaller market than the USA or Europe.

My first job in Regulatory Affairs taught me the most valuable lesson of all: “Always go back to the source.” In this case, Jon doesn’t want to rely only this posting for his information on how to get a Medical Device License in Canada. He needs to start with the Regulations. The “helpful links” (http://13485cert.com/helpful-links/) page of my website tells you how to find the Canadian Medical Device Regulations (CMDR), but for those of you that just don’t want to work that hard, here’s the direct link: http://laws-lois.justice.gc.ca/PDF/SOR-98-282.pdf. The Regulations were most recently updated on June 27, 2012. If you want to know what the difference is between the current version and the previous version, I wrote an entire blog posting on just that topic (http://13485cert.com/did-canada-forget-about-document-control/). The posting is 762 words long, but the two-word answer is: “Not much.”

Now that Jon has the single greatest cure for insomnia, he skips ahead to the bottom of page 54. Rule 4 states that “all non-invasive devices that are intended to come into contact with injured skin are classified as Class 2.” This is the applicable rule for this device, but how does Jon know?

Jon identified a competing product for sale in the US and Canada so that he could verify the classification as Class II. In this case, the competing product was “Surgiseal.” Jon checked the establishment listing database at the US FDA, and for Canada Jon reviewed the license information shown below.

Licence No.: 88330

Type: Single Device
Device Class: 2
First Issue Date: 2012-02-27
Licence Name: SURGISEAL TOPICAL SKIN ADHESIVE

 

Device Details
Device Section Identifier Section
First Issue Date Device Name First Issue Date Device Identifier
2012-02-27 SURGISEAL, TOPICAL SKIN ADHESIVE 2012-02-27 SS-035T

 

Now that Jon has verified this is a Class 2 device in Canada, Jon needs to review the Canadian Licensing Process. In the  CMDR, starting on page 16 (Section 32), Jon reviews the process of applying for a Medical Device License. He also reviews the Guidance Document for “How to complete a new medical device license application.” The location of the Health Canada Guidance Document is: http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_licapp_im_ld_demhom-eng.php. Fortunately, this is a Class II device and the requirements are primarily to complete the application form and to sign attestations regarding compliance with the safety and effectiveness requirements (Section 10-20 of the CMDR) and compliance with the labeling requirements (Section 21-23 of the CMDR). The application form has a new section requiring information about phthalate content of the device in the application. However, this tissue adhesive would only have phthalates if it was contained in the packaging.

After Jon’s review, he meets with the client to explain the next steps of the process:

1. The client needs to upgrade their existing ISO 9001:2008 Quality Management Certificate to an ISO 13485:2003 Certificate with CMDCAS. “CMDCAS” is the Canadian Medical Device Conformity Assessment System. The Quality System Auditor from the registrar will look for additional requirements specific to the CMDR, but all of these requirements are identified in GD210—another guidance document from Health Canada. This will only require a one-day external audit to upgrade the scope of the current certification.

2. Jon and the client need to revise the labeling to meet the requirements for Sections 21-23 of the CMDR. Since this product will be used by Medial Professionals, rather than an over-the-counter product, the labeling requirements are similar to Europe and the US. The most important thing to do will be to implement the use of appropriate symbols found in ISO 15223:2012—an Internal Standard for Labeling and Symbols.

3. The client will need Jon to conduct an internal audit to the CMDR requirements prior to the certification upgrade audit.

4. Finally, once the new Quality System Certificate is received Jon and the client can complete the application and submit the application with a copy of the new certificate.

In all, Jon estimates that his client can complete this process in less than 60 days. When the client gets an upgrade quotation from their registrar, the earliest date available is in 10 weeks, but their annual surveillance audit is already scheduled for 13 weeks. Therefore, the client decides to combine the two audits to save money on the travel costs and to give themselves a little more time to prepare.

Not all applications are this easy. For higher risk devices (i.e. – Class 3 and 4), summary technical documentation (STED) must be submitted in paper and electronically. Canada provides guidance documents for this, and there is a Global Harmonization Task Force (GHTF) document that explains how to prepare these documents. Depending upon the Classification and complexity of the device being submitted, this documentation can take weeks or months to prepare. The documentation matches the requirements for Technical Files required by Europe for CE Marking and 510(k) submissions required by the US FDA. However, the documentation can be prepared for most devices in less than 6 months—including biocompatibility testing and sterilization validation. This can also be done in parallel with obtaining ISO 13485:2003 certification. The only item that might require longer is if Clinical Studies are required—which is only required for high-risk devices or novel devices that are dissimilar from other devices already on the market.

Filed Under: All, Medical Device - General, Strategy vs. Tactics Tagged With: , , , , , , ,

FDA 510(k) or CE Marking?

July 10, 2012 By Leave a Comment

Today’s guest post comes from Rob Packard. Rob is a Regulatory Affairs and Quality Management System expert whose specialty is helping companies with regulatory submission of a Design Dossiers for CE Marking of high-risk Class III medical devices. You can read more of Rob’s work at QC is Dead and RA Review blogs. 

I’ve read a few business plans that propose to obtain a 510(k), CE Marking and a Canadian Medical Device License all in six months. My first impression is, “Lots of Luck!” Often I will ask how many people are working on this ambitious regulatory project. If the answer in “one”, they haven’t even got a clue. For a low-risk device this MIGHT be possible, but there are “If” qualifiers:

  1. If the device is a Class 2 device in the US requiring a 510(k), and the device is extremely similar to the predicate device, the 510(k) might get approved within 90-120 days.
  2. If the device is a Class IIa device in Europe, an expedited review ($$$) can be as short as 90 days.
  3. If the device is a Class 2 device in Canada, a Medical Device License can be approved in less than 60 days.
  4. If the company has already completed all the verification and validation testing, including any electrical safety and shelf-life testing, a regulatory expert can assemble a submission for all three markets in less than 60 days—assuming the design team has already written most of the documentation.
  5. If the regulatory expert has successfully submitted multiple applications to each of these markets previously, they will have templates to work from and know exactly what each country wants—including formatting.
  6. If the company already has a registered Quality Management System (i.e. – ISO 13485:2003 with CMDCAS), then they won’t need to have a Phase 1 audit, open a bunch of CAPAs, have a Phase 2 audit, and open some more CAPAs.

On rare occasions a motivated team can accomplish the impossible. For example, I started helping a team last year around August 1st. The team was half-way done with their Technical File for CE Marking, already had a 510(k), and they had just finished a pre-assessment audit for ISO 13485. After an obscene amount of work, we achieved CE Marking of their Class IIa device by mid-November (~100 days). CMDCAS and a Canadian Medical Device License application would have killed us, so we postponed that goal for this year.

Why would you want to commit your team to such a ridiculous goal of 3 regulatory approvals in a 6-month period?

The answer is that most companies have the common sense not to. Instead, most companies pick one market and focus on that. Most US-based companies pick the US market and submit a 510(k) first. Why?!

The 510(k) process is harder than CE Marking, new technology takes three years longer on average to get approved in the US than Europe, and the rules change faster than the US FDA publishes guidance documents to explain what they are doing.

Canada is the least rigorous of the three markets I mentioned (If you really want easy, New Zealand only requires registration—there is no “approval” at all for that market.). The Canadian market is 10% of the US Market size, and New Zealand is…well not worth comparing. Europe, however, is a big market.

Most small and mid-sized medical device companies rely upon distributors to sell their devices rather than developing their own direct sales force. What difference does it make if you are selling to a distributor in Austin, TX or Galway, IRE? If your company is going to use distributors, pick the easier regulatory hurdle first and work your way up the ladder of difficultly while your distributors bring in some cash.

Success in any business is about sales, sales and sales.

Before you even start designing a medical device, you should be talking to potential distributors. Distributors and sales people are one of the best sources of product ideas. If you are a CEO/founder hopeful, you are more likely to succeed if your background is sales and marketing. Engineers can invent 100’s of medical devices and mousetraps (MD&M), but it is rare to find an inventor that can sell—let alone explain the difference between the strategic marketing plan and the advertising plan.

My advice is to start with the strategic marketing plan for Canada and then one or two countries in Europe. If you have trouble identifying distributors for your type of device in these markets, then you are not competent as a sales and marketing person. You need to get help!

If you don’t know where to look for help, you might ask your regulatory expert. Regulatory experts have to research the competitor products in order to identify known risks and typical adverse events. Regulatory experts also need to identify the competing products before they can be certain of a regulatory pathway. Authorized representatives are sometimes quite helpful in identifying distributors too.

My final advice is to save the US Market for last!

Filed Under: All, Ask CQ, Medical Device - General, Strategy vs. Tactics Tagged With: , , , , , , , ,

Simplifying Medical Device Design Controls

April 20, 2011 By Leave a Comment

If you are like most medical device companies, the term “design control” is usually met with a cringe or two. I also suspect your product development process and design control deliverables might be more cumbersome and quirky than you’d like–especially since you are expected to complete your medical device product development efforts as quickly as possible.

And what happens once the product development project is complete? Do you file the design control records away in a design history file (DHF) and archive them in some file cabinet or electronic record system? How easy are these to retrieve and access for future projects? Do other groups, such as regulatory affairs have access to DHFs in order to compile regulatory submissions such as 510(k)s and technical files?

What if you had a software solution to document design controls as they happen? What if this same solution could be a living repository for all design control and product development activities? What if this same solution could also pre-populate regulatory submissions?

Don’t think this product exists? Think again. Creo Quality’s UniDoc software is the solution you need to streamline your medical device product development efforts.

UniDoc is developed from proprietary database platform software and be mapped to match your current product development and design control processes. The software is 21 CFR part 11 compliant and meets FDA, EU, and Canadian regulations for medical device design controls. UniDoc contains modules for key regulatory submissions, including FDA 510(k), FDA IDE, EU technical file, and Canadian submissions.

If you are interested in learning more about UniDoc and how you can get this product at your company, contact us: info@creoquality.com or 765 315 2736.

Enhanced by Zemanta
Filed Under: All, Catalyst, Design Input Requirements, Product Development - General, Project Management, Project Phases, UniDoc Tagged With: , , , ,

Creo Quality Launches UniDoc Medical Device Software

January 26, 2011 By Leave a Comment

Medical device companies worldwide are faced with regulatory challenges when getting new products to the market.

“Through our consulting engagements, we are often engaged in assisting clients with regulatory submissions to gain market clearance throughout the world. We have assisted clients with FDA 510(k)s, EU technical files, Canadian, and other regulatory submissions. The current industry best practices are very labor intensive and ideally require substantial expertise. Surprisingly, there are few tools and options available to streamline medical device product development and regulatory documentation processes. We have long considered there has to be a better way. The UniDoc software platform is our solution.”, stated Jon Speer of Creo Quality.

UniDoc is a software solution to streamline medical device design control documentation and records.

“Regulatory submissions are in large part a result of medical device design control and product development documents. However, compiling this information for a regulatory submission is time consuming and requires significant expertise,” stated Scott Durlacher of Creo Quality. “We believe UniDoc is the solution to store and maintain invaluable design control records for all uses within a company. We believe UniDoc will improve quality and efficiency of regulatory submissions, while reducing the amount of time and resources required from a company’s regulatory staff.”

UniDoc is developed from proprietary database platform software. The software is 21 CFR part 11 compliant and meets FDA, EU, and Canadian regulations for medical device design controls. UniDoc contains modules for key regulatory submissions, including FDA 510(k), FDA IDE, EU technical file, and Canadian submissions.

Creo Quality is rolling out version 1.0 of UniDoc on a limited release. If interested and for pricing information, please contact us atinfo@creoquality.com or 765-315-2736.

Enhanced by Zemanta
Filed Under: All, Catalyst, Design Control, Medical Device - General Tagged With: , , , , ,