• Recognition and Withdrawal of Voluntary Consensus Standards: Draft Guidance
• Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices : Final Guidance

Podcast on Standards & FDA’s Release of these Guidance Documents

FDA’s Captain Scott Colburn and Leo Eisner of Eisner Safety Consultants did a podcast with Jon Speer of Greenlight Guru on Standards Development of the IEC 60601 Series and these recently released Guidance documents. Listen to this conversation…

Some of items of note with the Final FDA Guidance include:

• FDA can now Recognize a standard and place on the Recognized Consensus Standards db prior to a formal Federal Register updates
• Declaration of Conformity (DOC) to follow requirements of ISO 17050-1 or as specified in the Final Guidance in section IV. A. (1)
• DOC process different for Consensus Standards that are horizontal, process-oriented, or that include choices relating to test methods, test selection, or have guidelines that apply to a broad range of device types and safety issues then FDA recommends submitters follow ISO 17050-2 – Supplier’s DOC – Supporting Documentation per section IV. A. (2) of the Final Guidance

IEC 60601-1, edition 3.2 (draft) and it’s collateral standards (IEC 60601-1-XX) are being updated and Leo discusses why this is happening, the timing and some of the impacts on manufacturers and design houses in this podcast.

FDA Guidance Documents – Additional Information

The draft guidance will be open for public comments and suggestions for 60 days at https://www.regulations.gov under Docket Number: FDA-2018-D-2936.

The Appropriate Use of Voluntary Consensus Standards final guidance describes the appropriate use and documentation of consensus standards for premarket submissions and how FDA staff intends to rely on consensus standards during the review process. Appropriate use of voluntary consensus standards can reduce requests from FDA staff for additional information to address issue(s) the standard was intended to address.  This guidance provides further clarity and explanation about the regulatory framework, policies, and practices regarding the appropriate utilization of consensus standards for premarket submissions.:”

Webinar about the Appropriate Use Final Guidance:

FDA will be hosting a Webinar on Thursday, October 25th, 2018. The webinar will be for manufacturers & others interested in learning more about the Appropriate Use final guidance. No registration is required.

• Time: 1:00 – 2:00pm EST (To ensure you are connected, dial-in prior to the start of the webinar)
• To hear the presentation and ask questions:
  Dial: 800-475-0481, International Callers Dial: 1-517-308-9467; Conference Number: 8090070; Passcode: 2387655
• To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW8090070&p=2387655&t=c
• Following the webinar, a transcript, audio recording, and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.

Need help sorting out the proper medical device standards that apply to your device submission for the US, Canada, EU or elsewhere? Contact Leo “the IEC 60601 Guy” Eisner to help you thru this process at Leo at EisnerSafety dot com or schedule a call with Leo.

View all the articles I have written for InCompliance Magazine.

I hope you enjoy this article and if you have any questions please feel free to contact me at Leo at EisnerSafety dot com or schedule a call with me.

So, what are the guidance documents and the deadlines to provide feedback to the IMDRF?

WARNING; It is critical to be aware that each comment template is specific to a specific draft guidance document and if you don’t use the proper one your comments could be skipped over or not aligned with the proper guidance document and you would then not have your comments covering what you are commenting on so be careful and double check on the IMDRF website as they may update the documents and this post will not go back and update these links.

First, let’s look at the UDI System for Medical Devices (Version 2.0).  The GHTF issued a version of this guidance back on 16 Spet 2011.  The IMDRF document clarifies and supplements the GHTF document. From the introduction the Guidance document tells us: “This guidance provides a framework for those regulatory authorities that intend to develop their own UDI Systems…In order to reach the goal of a globally harmonized UDI System, it is critical that these systems are implemented without regional or national differences. This guidance is intended to provide a high-level conceptual view of how a global UDI System should work.”  It goes on to say that additional guidance may be needed once the core concepts are implemented.

The Guidance goes on and indicates that there are 7 fundamental concepts of a globally harmonized UDI System and includes:

• the UDI and UDI Carrier are based on global standards
• a UDI applied to a medical device anywhere in the world should be able to be used globally to meet the UDI requirements of any regulatory authority
• national or local identification numbers should NOT be a substitute for UDI
• regulatory Authorities should not specify how to modify these standards
• the UDI Database (UDID) core elements should not be modified
• the UDID should use the HL7 SPL for data submission
• each medical device needs to be identified by a UDI

Comments are due by 31 July 2013.  If you want to submit comments please use either of the comment templates Comments template – DOC (32kb) or  Comments template – PDF (56kb).  They ask that the comments are sent to EC-IMDRF2013-SECRETARIAT@ec.europa.eu.

Let’s look know at the other documents of interest which are a set of 2 documents that are related to the Third Party Audit Process.   These two guidances aim to establish a common set of criteria for medical device auditing and monitoring organizations and the competency of their employees.

The first of the series of two guidance documents we will look at is the draft guidance on Recognition and Monitoring of Organizations undertaking Audits of Medical Device Manufacturers issued on 5 April 2013 with comments being due on 14 June 2013.  The guidance says “IMDRF developed this document to encourage and support global convergence of regulatory systems.”  The document goes on to say that the concept was first addressed by the GHTF and “IMDRF seeks to further the work of the GHTF in this document by providing a common set of criteria to be utilized by the Regulatory Authorities for the recognition and monitoring… of entities that perform audits…”  “The functions covered by an Auditing Organization, within the scope of this document, and roles assigned are described” below:

Functions                                         Audits On-site             Audit/Decision Off-site

Conduct assessment application review       n/a                             Program administrator
to determine audit team competence
required, select the audit team members,
and determine audit duration

Assessment of quality management            Lead Auditor/Auditor    n/a
system

Assessment of product related                    Technical Expert         n/a
technologies

Assessment of Technical Files                   Technical Expert         n/a

Assessment of Regulations                        Lead Auditor/Auditor/   Final Reviewer/
                                                                Technical Expert         Technical Expert

Comments are due by 14 June 2013.  If you want to submit comments please use either of the comment templates Comments template – PDF (31kb) or  Comments template – DOC (54kb).  They ask that the comments are sent to the Medical Device Single Audit Program (MDSAP) Working Group Chair, Ms. Kim Trautman and with a copy to the IMDRF Secretariat.

The second in this series of draft guidance documents is titled Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers.  It was issued on 31 January 2013 with comments due by 14 June 2013. The draft guidance states “The purpose of this document is to specify competency requirements that shall be demonstrated and maintained by recognized Auditing Organization for personnel involved in medical device regulatory audits and decision making.”  The document is “for personnel involved in audits and decision making functions for assessing conformity with regulatory requirements for medical device manufacturers, and includes:

• Defining knowledge, skills, and abilities
• Criteria for various degrees of competency based on roles in audits and decision making functions
• Assisting in evaluation and development
• Providing a basis for identifying training needs

MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance System was updated in January 2013.  The revised guidance is applicable as of July 2013.   The revision contains clarifications rather than significant changes.

Download the MEDDEV 2.12/1 revision 8 Guidelines on a Medical Device Vigilance System effective July 2013.  An unofficial Comparison of MEDDEV 2.12/1 from revision 7 to revision 8 can be downloaded, as well. 

Changes include:

• Clarification that, in addition to IVD’s, indirect harm can be from:
  • diagnostic devices,
  • consequence of the treatment of cells (e.g. gametes and embryos in the case of IVF/ART devices) or organs outside of the human body that will later be transferred to a patient, or
  • software qualified as medical devices (e.g., incorrect information generated by software).
• Reinforcement that, when there is doubt, a report should be submitted.
• Clarification that, regardless of how a lack of performance to labeled specifications is identified (field report, in-house testing, etc.), if the issue might lead to or might have led to death or serious deterioration in the state of health associated with the use of the device and the issue impacts a product that has already been placed on the market then a field safety correct action (FSCA) must be initiated.
• Adds “absence of treatment” as an indirect harm that must be considered.
• Indicates that a National Competent Authority should consult the manufacturer or the manufacturer’s European Representative before forwarding a National Competent Authority Report (NCAR) to fellow National Competent Authorities.
• Updates to reporting formats from the MEDDEV website are below in the formats that they provide them in:

Manufacturer Incident Report(971 KB) 
How to use the MIR(13 KB) 
Field Safety Corrective Action(2 MB) 
Trend Report(151 KB) 
Periodic Summary Report(192 KB) 
MIR and FSCA xml files(2 MB)  

Actions to consider:

• Review your MEDDEV procedure(s) to ensure that:
  • Any source of indirect harm will be considered and, if such could result in harm, will result in submission of an incident report.
  • Actions taken to reduce risk of death or serious deterioration in the state of health associated with the use of a device that is already placed on the market will be reported through a Field Safety Corrective Action Report.
  • “Absence of treatment” is an indirect harm that will be considered when making a reporting decision.
  • Where there is doubt, a report will be submitted.
  • Referenced forms reflect the current versions and requirements for completion.
• Review the contract with your European Representative to ensure that it is clear on how the company expects the EU Rep to respond to a request for comment on a NCAR.

Many thanks to Helene Spencer to highlighting the new revision (and for indicating that, with a little work, it is possible to create an unofficial redline).

If you need assistance with this or other issues, please contact us at Leo@EisnerSafety.com.  As a reminder, you can access a full list of MEDDEV’s from the MEDDEV guidance website .

Several European medical device guidance documents (MEDDEVs) have been newly released or updated as noted below.  A brief note of significant points is provided.

–        MEDDEV 2.12/1 Medical devices vigilance system (UPDATED – March 2012):

o   Changes that will likely affect your current procedures are:

§  2 new report forms (Annex 7 – Trend Report Form and Annex 6 – Periodic Summary Report Form), and
§  updates to 2 existing report forms (Annex 3 – Incident Report Form and Annex 4 – FSCA Form).

o   The revised guidance is applicable as of 15JUN12.
o   Overall, the content of the guidance has not changed significantly.  Minor changes appear in Section 4.5 – EUDAMED, Section 4.18 – Trend Reporting, Section 5.1.2 – Summary Reporting, Section 5.1.3.6 – Negligible Likelihood, Section 5.1.4 – Trend Reports, Section 6.3.1 – Circumstances (Coordinating NCA), Section 6.3.5 – Information between NCAs, Annex 1 – Examples, Annex 2 – Extracts from Directives, and Annex – GHTF Documents Used.  The numbering of some Annexes has changed.
o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_12_1-rev_6_mir_en.pdf.  Also see the Manufacturer Incident Report (MIR), http://ec.europa.eu/health/medical-devices/files/meddev/2_12_1-rev_6_mir_en.pdf; How to Use the MIR, http://ec.europa.eu/health/medical-devices/files/meddev/mir_use_en.pdf; and Field Safety Corrective Action report form, Field Safety Corrective Action.

–        MEDDEV 2.12/2 Post Market Clinical Follow-up (PMCF) studies (NEW):

o   Guidance provides insights into when a PMCF study should be considered, general principles for conducting a PMCF study, use of PMCF study data, and the role of the Notified Body.
o   The Notified Body is now required to “verify that PMCF is conducted when clinical evaluation was based exclusively on clinical data from equivalent devices”.  Any plan to justify no PMCF study in this case should be reviewed with your Notified Body at the earliest date possible.
o   Note that incidents that occur during PMCF studies conducted with CE marked devices within their intended uses are subject to Vigilance reporting requirements.
o   The guidance does not apply to IVD devices.
o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_12_2_ol_en.pdf. 

–        MEDDEV 2.5/10 Guideline for Authorised Representatives (NEW – January 2012) [only applies with the manufacturer is outside the EU]:

o   Guidance clarifies what the Representative is required to do (e.g., keep Declarations of Conformity and Technical Documentation at the disposal of the national authorities) and discusses what the Representative may be requested to do.
o   It also clarifies that a Representative is required for devices intended for clinical investigations.
o   Per the guidance, a contract is considered vital.  I recommend that you review the current contract with your Representative to ensure that all points noted in this guidance are addressed in the contract.
o   Available at http://ec.europa.eu/health/medical-devices/files/meddev/2_5_10_ol_en.pdf.

 –        MEDDEV 2.1/6 Qualification and Classification of stand alone software (NEW – January 2012):

o   Guidance walks you through how to determine if software is a standalone device.
o   It also describes how to determine its MDD classification or select the IVDD Annex.
o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_1_6_ol_en.pdf.

 –        MEDDEV 2.14/1 IVD Medical Device Borderline and Classification issues. A guide for manufacturers and notified bodies (UPDATED – January 2012):

o   Guidance walks you through:

§  deciding whether a device is a general laboratory or IVD device;
§  deciding whether a device falls under the IVDD or MDD; as well as
§  addressing kits that contain IVD devices, medical devices and other components.

     The manufacturer’s stated intended use is key to addressing these issues.

o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_14_1_rev2_ol_en.pdf.

–        MEDDEV 2.2/4 Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products (NEW – January 2012):

o   Guidance discusses how to determine, based on mode of action, when IVF/ART products fall under the MDD.
o   It describes issues to consider to address each MDD essential requirements along with most market considerations for traceability, vigilance, post-market clinical follow-up, and design modifications.
o   It also walks you through how to determine classification (usually Class III per Rule 13 as most incorporate one or more medicinal products).
o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_2_4_ol_en.pdf. 

–        MEDDEV 1.14/4 CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP (NEW – January 2012):

o   Guidance is specific to variant Creutzfeldt-Jakob Disease (vCJD) [CJD is commonly called “mad cow” disease].
o   As the current Common Technical Specifications (CTS) cannot be adapted easily to vCJD assays, the guidance identifies basic quality requirements for vCJD assays.
o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_14_4_ol_en.pdf.

The full list of MEDDEVs is available at http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm.  

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The next 2 blog postings are thx to Erik Vollebregt who is a Life Sciences and IP (Intellectual Property) lawyer based in Amsterdam and is one of the founding partners of Axon Lawyers.  His posting is titled:

+ New EU guidance on Post Market Clinical Follow-Up Studies published and other MEDDEV guidance announced
+ New MEDDEV on authorised representatives: everything you know is wrong

Erik has a blog that I visit frequently for EU MDD & AIMDD information.  Erik & I communicate on occasion to discuss various EU issues related around the EU MDD & AIMDD.  He has been a great resource of information to Eisner Safety Consultants.  

The UK MHRA has updated their website to be much more functional and you can find a lot of information about the Directives (i.e. MDD, IVD, & AIMDD) related to the medical devices. Also, you can find the UK transposed regulations and many other useful items such as classification information, borderline documents, the conformity assessment process, regulatory news, details on revisions of the MDD, Vigilance, Notified Bodies, and much much more. The site links you to multiple places to the Europa website for things such as the Interpretation & guidance documents and more…

If you are looking for information on Medical Devices under the MDD this is a good link to look at for lots of information on the subject.

If you are looking for information on Medicines legislation & directives this is a good link to look at for lots of information on the subject.

They even set-up a page for New Technologies Forums for both Medicines and Medical Devices.

Health Canada is pleased to announce the release of the Guidance for the Interpretation of Significant Changes.

The Medical Devices Regulations (Regulations) set out the requirements governing the sale, importation and advertisement of medical devices. The goal of the Regulations is to ensure that medical devices offered for sale in Canada are safe and effective and meet quality standards. Class II, III and IV medical devices sold in Canada are required to be licensed under section 26 of the Regulations. Section 34 of the Regulations describes five instances when a manufacturer is obliged to apply for an amended medical device licence. One of those instances is when a “significant change” is proposed to a Class III or IV device.

This guidance document elaborates upon the definition of “significant change” in the Regulations, in order to assist manufacturers in determining whether a change proposed to a class III or IV medical device requires the submission to Health Canada of a licence amendment application, prior to introducing the device to the market.

This guidance document will replace the 2003 Guidance for the Interpretation of Significant Change of a Medical Device. The major changes include updated examples of significant changes and a restructuring of the guidance for additional clarity.

For further information on the revised Guidance for Industry: Guidance for the Interpretation of Significant Change of a Medical Device, please contact:

Manager, Device Evaluation Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Room 1605 Main Building
150 Tunney’s Pasture Driveway
Address Locator: 0301H1
Ottawa, Ontario
K1A 0K9

Email: MDB_enquiries@hc-sc.gc.ca
Phone: (613) 957-7285
Fax: (613) 957-6345