Compliance to standards has become a key part of regulatory requirements. Due to move towards Global Harmonization of regulations, it has become important not only for the developed markets of US, EU, etc. but also the emerging markets (e.g. China, Brazil, etc.)

Our new service helps you identify the required standards and editions for your intended markets.                                                                   

Our service helps medical electrical device manufacturers (our specific focus of our database) keep up to date on new standards, updates to existing standards, and draft standards under development. This assures you can plan ahead of any major changes.

We reduce your burden on this time consuming task, so you can focus on what you are good at – developing products.

We do this at very reasonable rates.  We are offering to early adopters an extra discount on the price and extra time (3 months) will be added to the first year subscription. 

See our demo page for the types of reports we generate for the service. Find out more about the service.

We decided to take a little extra time to capture the large amount of information involved.. We will be Live by Mid Oct 2015.

Sign-up now for a live release notification and you will receive a special limited time offer that no one else will receive after we go live!! If you would also like to receive our Eisner Safety Consultants Newsletter sign-up here. Also, early adopters get an extra discount on the price and will get an additional 3 months added to their first year subscription if you sign-up in time.

What does the Service Provide:

The service includes several databases:

1. The Standards database is the primary focus. It includes standards, technical reports, technical specifications and guides. It includes new documents, updates to existing documents, as well as drafts under development (e.g. New Work Proposals, Committee Drafts, etc.)
2. List of standards publishers and the associated country.
3. List of Medical Device Regulators and their websites (if available).
4. Guidance Documents related to the standards for key markets. [Coming Soon]

A periodic report** is provided as part of the service.

All paid subscribers will have the ability to:

• Run searches of subscribed databases
• Print out search results from displayed data
• Print out tables of results in tabular format
• Export data for generation of your own reports (based on terms of service)
• Multiple user log-in for your company (limited to 5 unique user log-ins)

Discount for Initial release: We are releasing the database in stages, the early adopters (Current stage – stage 1) will get a discount (20%) for the first annual subscription cycle and an additional 3 months added to their subscription if you sign-up in time.

Sign-up now to receive a live release notification and you will receive a special limited time offer that no one else will receive after we go live!! If you would also like to receive our Eisner Safety Consultants Newsletter sign-up here.

Stage 2 will add Guidance Documents for the US, Canada, and EU. Also, list of standards publishers and the associated country will be expanded to cover 50+ countries. Stage 2 will be released by early 2016.

Stage 3 will expand the standards database to include US, EU, and Canadian versions of the IEC standards & IEC/ISO joint documents. It will also expand the regulators information and their websites beyond the key markets. Stage 3 will be released early Spring 2016.

Stage 4 will expand the standards database to include the supporting (non-electrical) medical standards used for your regulatory submissions e.g. ISO 10993 series, ISO 15223-1, etc. Stage 4 will be released early Fall 2016.

View details on the Subscription Levels

Please feel free to contact me with any questions you may have. I can be reached by e-mail or phone at Leo@EisnerSafety.com and 503-244-6151 (Office) and 503-709-8328 (Cell).

Does your Medical Device Regulator or your Quality System require that you maintain a list of applicable standards to meet these requirements for your product lines?  How much time does it take to put this list together and how much effort does it take to keep the list updated? If this is a struggle for your organization to keep up with all the different data sources we have the solution for you at a reasonable price. A Standards Reconnaissance Subscription Service to help medical electrical device manufacturers keep up to date on all the changes that occur for these documents so you are prepared for future changes well ahead of the norm and you are able to stay up to date on your list of standards. The focus of this service will be on the documents for medical electrical equipment & systems (MEE&S = IEC TC 62, SC 62A – 62D) and home use medical electrical equipment & systems (Home Use MEE&S = IEC Active Assisted Living System Committee (IEC AAL SyC) and any other Home Use medical electrical equipment documents from the IEC TC 62, SC 62A – 62D including IEC 60601-1-11 Home Use Environment).

We plan to go live with the db by the end of Sept 2015.

Please reserve your spot by September 28, 2015 for this db subscription service.

Some of the features will include [For Paid Subscribers unless noted otherwise]:

• Notification e-mails when changes occur (i.e. Change in transition information from FDA for a standard) and new records are entered into the db.
• Receive either 2 or 4 reports per year (depending on Subscription level) summarizing:
  • key issues of that report cycle for MEE&S or home Use MEE&S,
  • estimated timeline for the publication of draft standards & other relevant documents of significance, and
  • full listing of all the documents in your part of the db with status information.
• Access to our searchable db (depending on Subscription level access to the either the MEE&S or Home Use MEE&S part of the db or the whole db) on our dedicated db website if you are a paid subscriber. [Limited access for free level of service with 10 – 15 standards (pre-defined)]
• Print out db search results the way you want them
• Export db search results for your use (limited by the terms & conditions of the db)

There are several parts of this db [For Paid Subscribers unless noted otherwise]:

• Standards db – including information on the standards, technical reports, technical specifications, and publicly available specifications that are active or current, in draft or development which would include voting level documents such as New Work Proposals, Committee Drafts, etc., and withdrawn documents (The previous version of the active standard).
• List of standards publishers & associated country (this will cover 50+ countries) [includes free service level],
• List of Medical Device Regulators with their websites, if available, for a selection of countries including all the of EU & EFTA countries.  We plan to expand this to include all countries in the world by the end of Stage 2 (below),
• Guidance Documents – Guidance documents that the regulatory bodies use for their national regulatory systems. Like for the US, Canada, & Europe. They will be added sometime after going live by end of stage 2 or 3 (see below).

Once the db goes live you can check out how the db works by accessing the free level of service to view a few examples of current standards (about 10 to 15). With the free service level you will be able to use most of the db features set other than obtaining reports, the update notification service, but you will not have access to List of Medical Device Regulators db of Guidance documents db.

Pricing starts at only:

• $4,500/year for Base Entry Subscription (2 reports per year and select either MEE&S or Home Use MEE&S part of db),
• $6,500/year for Mid-Level Subscription (4 reports per year and full access to db), or
• $9,000/year & up for Premium Subscription (2 personalized reports for your company’s needs based on conversations with Leo Eisner, 2 reports per year from the Premium Subscription level, and full access to db)
  All payments to be paid in US$ only.

We plan to go live with the db by the end of Sept 2015. Since we will be releasing the db in stages the early adopters will get a discount (20%) for the first annual subscription cycle and additionally we will throw in extra months to your subscription commensurate with how early you subscribe.  The earlier you subscribe the more free months will be added to your first yearly subscription for no additional charge.

Please reserve your spot by September 28, 2015 for this db subscription service and to guarantee a discounted first year price and to obtain extra months added for free. To reserve your spot for the Base entry or the Mid-Level Subscriptions please arrange a $750.00 (US$) deposit and for the Premium Subscriptions please arrange a $1,500.00 (US$) deposit. Contact us to arrange for deposit.

There will be a couple stages for the release of information for the db.  We plan on continual updates over time to provide a really valuable resource and continually make it better. The first stage will be complete prior to the official release of the db which will include all the updated information for the IEC based MEE&S & Home Use MEE&S documents including updates on the small number of joint IEC/ISO documents.  Stage 2 will be initiated just before the release of the db, which will include updates for the US, EU, and Canadian versions of the IEC & IEC/ISO MEE&S and Home Use MEE&S documents and IEC/ISO joint documents. We plan to have stage 2 completed around Jan 2016.  Stage 3 will include updated information adding in the supporting medical device (non-medical-electrical) documents you need for your regulatory submissions such as ISO 10993 series of standards, ISO 15223-1, etc.  This stage will initiate with the non-medical-electrical standards for IEC and ISO and in the future we will add other Standards Developers.  We expect to start on stage 3 around Jan 2016 and have not yet scheduled it’s completion.

Please contact Leo Eisner to find out more details about this db. He can be reached by e-mail or phone at Leo@EisnerSafety.com and 503-244-6151 (Office) and 503-709-8328 (Cell).

11 June 2015 – Scrip Regulatory Affairs – Article written by Leo Eisner titled “Everything you needed to know about who’s doing what where with IEC 60601-1 – Part 1” Article discusses how the standard (IEC 60601-1 3rd ed. or ed. 3.1) is being used by Regulatory & Standards Organizations for the USA and Canada.

To read this article please go to Featured Articles webpage. Thank you Scrip Regulatory Affairs for allowing us to post on our Featured Articles Page of our Website.  This is not for public distribution please refer your associates that you want to read the article directly to the Featured Articles webpage.

We are in the process of setting up a standards reconnaissance service where we monitor the MEDICAL ELECTRICAL EQUIPMENT and HOME USE MEDICAL ELECTRICAL standards of your choice.  If you are interested in this service please contact Leo Eisner at Leo@EisnerSafety.com or 503-244-6151.  We would be happy to discuss what we can do for your organization as Leo is on many of the standards committees that these standards are involved with.  Below is a summary of my involvement in these committees.

Leo is a co-chair of the U.S. TAG (technical advisory group) for IEC/SC 62D, a member of the US TAG for TC 62 (Electrical Equipment in Medical Practice), SC 62A (Common Aspects of Electrical Equipment Used in Medical Practice) and SC 62D (Electromedical equipment).  He is the convener of SC62D JWG9 “Lens removal and vitrectomy devices for ophthalmic surgery”.  Leo is a member of the TC 62/SC 62A/WG 14 (Testing to General Safety Standard – The Working Group is chartered to develop recommendations regarding interpretation & application of IEC 60601-1 to testing of medical electrical equipment, and to deal with general testing requirements not assigned to other maintenance teams.)  To support the increase in demand for medical device Home Use and Wearables Leo is a member of the AAMI committee for Home Use Medical Devices and the US TAG for Active Assisted Living Syc (System Committee for all devices in various categories for the elderly which includes the home use medical device industry).

IEC TR 60601-4-3:2015 Guidance & interpretation of IEC 60601-1, 3^rd ed. Published

This post discusses the recently published Guidance IEC TR 60601-4-3:2015 that issues interpretations of IEC 60601-1, 3rd ed. and edition 3.1.

The technical report tiled IEC TR 60601-4-3:2015 Guidance & interpretation – Considerations of unaddressed safety aspects in the 3^rd ed of IEC 60601-1 & proposal for new requirements was released April 2015.  It deals with recommendations and interpretations of the IEC 60601-1, 3^rd ed. and edition 3.1 (or 3^rd ed. + A1).  IEC Subcommittee (SC) 62A established a process under which Working Group (WG) 14 would develop recommendations regarding problems of interpretation or application of IEC 60601-1.  I am a member of this WG.  Many of the WG14 experts are employed by test laboratories and manufacturers and have many years experience applying IEC 60601-1 to MEDICAL ELECTRICAL EQUIPMENT.  The one thing to be crystal clear about is in the INTRODUCTION of the document it says:

“While the National Committee members of SC 62A nominate these experts, their recommendations were not to be formally adopted through any official voting procedure. To reinforce this process, the Subcommittee specifically directed that the following note appear on every page of the resulting informational circular:

IMPORTANT NOTE: Per the 62A decision at Sydney…, the 62A Secretary is circulating this recommendation,…regarding problems of interpretation or application of IEC 60601-1 to all P-Member NCs.

This recommendation/interpretation is the result of considerations by a group of nominated experts and has not been formally adopted through any National Committee voting procedure. Distribution is only for information.

The INTRODUCTION of this Technical Report goes on to say:

“This technical report is intended to convey the results of WG 14’s work to interested parties such as MANUFACTURERS and test laboratories while retaining the informative nature of the material.

This first edition of IEC TR 60601-4-3 contains 93 recommendations, numbered 101 to 193. All these recommendations are based upon IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

The numbering starts with 101 instead of just 1 to ensure that these WG 14 recommendations (101 to 193) will not accidentally be confused with previous issued WG 14 recommendations 1 to 63, which are based on the second edition of IEC 60601-1 and published in IEC TR 62296.”

The other purpose of this document is that these recommendations may be potential sources for some of the changes to the IEC 60601-1 standard when it is up for it’s next round of changes.  The standards committees, working groups, and maintenance committees for IEC 60601-1 and it’s collateral standards (IEC 60601-1-XX) are in discussion if the next revision will start late this year or early next year.  There is a meeting of all the TC 62 (& SC62A – D) committees in Kobe Japan in Nov 2015 that will discuss this and probably have a formal vote to decide on the fate of the next revision of IEC 60601-1.  I plan to be at these meetings and involved in the discussions and decisions. If this vote is positive the earliest the changes would occur is sometime in 2019.  Stay tuned for more updates on the potential changes to the IEC 60601-1 standards and it’s related collateral standards.

As there are 93 recommendations sheets I will not note all of them in the below list but a sampling showing a cross section of the ones that draw my attention.  You can see from the list below that many of these were not addressed fully in the standard and this is the start of the resolution to these issues. Many of test houses use this document as their interpretations that they rely on until these decisions are finalized by being adopted into the next revision of the applicable standard (primarily IEC 60601-1).  But realize as the boxed text says these are not formalized so your test lab may not rely on them.  I would suggest that you check first with your Test Lab on the specific issues before assuming they are their interpretations.  You don’t want to use these and find out at the end of your test project that your lab doesn’t agree to the perspective on one or more of these recommendation sheets.  I would hate to see you redesign a product to find out the solution doesn’t meet the requirements for your lab.  As mentioned many labs do accept these but with added text box please be diligent and check first:

3.2.101             Total PATIENT LEAKAGE CURRENT of a ME SYSTEM

3.2.102             Pollution degree for MOPP

3.2.103             Transients on d.c. mains

3.2.104             Altitude factor for DEFIBRILLATION-PROOF APPLIED PARTS

3.2.105             Defibrillation energy protection for MOOP / MOPP

3.2.106             Overvoltage categories III and IV

3.2.107             Pollution degree related to different micro/macro environments

3.2.108             Warnings versus ALARM SIGNALS

3.2.109             Single Y1 capacitor for MOPP

3.2.111             CREEPAGE DISTANCE and AIR CLEARANCE for dental equipment

3.2.112             Short circuiting of one constituent part of DOUBLE INSULATION

3.2.113             Instability in transport position

3.2.116             Instability excluding transport position

3.2.119             Test equipment for recurrent tests according to IEC 62353 testing used within IEC 60601-1 type approval testing

3.2.124             WORKING VOLTAGE measurement

3.2.125             Defibrillation test

3.2.127             PERMANENTLY INSTALLED ME EQUIPMENT in the HOME HEALTHCARE ENVIRONMENT

3.2.129             Push buttons

3.2.132             Eye-verification of tester before legibility test

3.2.125             Labeling: spare parts vs. detachable parts vs. ACCESSORIES

3.2.144             Impedance of a PROTECTIVE EARTH CONDUCTOR within a DETACHABLE POWER SUPPLY CORD

3.2.149             Expected voltage on SIP/SOPs

3.2.151             COMPONENT WITH HIGH-INTEGRITY CHARACTERISTICS

3.2.153             Critical components

3.2.166             Keep dry and umbrella symbol

3.2.167             MOBILE and STATIONARY ME EQUIPMENT with wheels

3.2.175             Biocompatibility for quasi APPLIED PARTS

3.2.182             Chargers for ME EQUIPMENT used at home

3.2.186             Rationale for IP2X

3.2.187             Battery – limited power

3.2.191             The SIP/SOP pin to earth TOUCH CURRENT

3.2.193             MAINS VOLTAGE on APPLIED PART

This is a great resource to have throughout your design process and through the testing and beyond.  Always have it available so you can leverage the knowledge of these WG14 experts, including myself.  You can purchase this document from IEC, AAMI, and many other sources.  Go to http://www.eisnersafety.com/links/ to find a listing of standards Sales Organizations and also Standards Organizations.

We are in the process of setting up a standards reconnaissance service where we monitor the MEDICAL ELECTRICAL EQUIPMENT and HOME USE MEDICAL ELECTRICAL standards of your choice.  If you are interested in this service please contact Leo Eisner at Leo@EisnerSafety.com or 503-244-6151.  We would be happy to discuss what we can do for your organization as Leo is on many of the standards committees that these standards are involved with.  Below is a summary of my involvement in these committees.

Leo is a co-chair of the U.S. TAG (technical advisory group) for IEC/SC 62D, a member of the US TAG for TC 62 (Electrical Equipment in Medical Practice), SC 62A (Common Aspects of Electrical Equipment Used in Medical Practice) and SC 62D (Electromedical equipment).  He is the convener of SC62D JWG9 “Lens removal and vitrectomy devices for ophthalmic surgery”.  Leo is a member of the TC 62/SC 62A/WG 14 (Testing to General Safety Standard – The Working Group is chartered to develop recommendations regarding interpretation & application of IEC 60601-1 to testing of medical electrical equipment, and to deal with general testing requirements not assigned to other maintenance teams.)  To support the increase in demand for medical device Home Use and Wearables Leo is a member of the AAMI committee for Home Use Medical Devices and the US TAG for Active Assisted Living Syc (System Committee for all devices in various categories for the elderly which includes the home use medical device industry).

Our Associate Dale Hallerberg provided a short note about this recently published AAMI Guideline on Medical Device Safety Testing.

AAMI has published Technical Information Report (TIR) 62354:2015 “General testing procedures for medical electrical equipment”.  This report is available from AAMI at http://my.aami.org/store/SearchResults.aspx?searchterm=62354&searchoption=ALL. This document is identical to the IEC TR 62354:2014 published last September, and gives detailed guidance to manufacturers, test houses, and other interested parties on the steps involved in the safety testing of medical electrical equipment.  It builds on the test requirements of IEC 60601-1:1988 (including the collateral provisions of IEC 60601-1-1:2000) and IEC 60601-1:2005 and IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 but goes much further into testing details.  Examples of the content of the TIR include a description of the power supply needed for testing, the sequence of testing, the test equipment needed for each test, production-line tests, and much more.

This Report is not normative — which means it is not mandatory — however it gives excellent guidance and should be read and used by any laboratory interested in accurate, repeatable testing of medical electrical equipment or manufacturer and other interested parties in learning more about how the tests are conducted when their product goes to a test lab for IEC 60601-1 Certification Testing.  

If you need additional support for any of the IEC 60601 series of standards please email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

White Paper on The growing role of human factors and usability engineering for medical devices

This white paper is on “The growing role of human factors and usability engineering for medical devices”and is focused on “…applying knowledge of human capabilities and limitations Human Factors and Usability Engineering (HF/UE) contributes to the design of intuitive displays, controls, and other interfaces that substantially reduce the risk of user error.”  It is written by Bob North, Human Centered Strategies.

I have the distinct pleasure and honor of assisting BSI review this white paper as a member of the BSI Medical Devices White Paper Advisory Panel for this series of white papers.

White Paper Series 

This is the last planned white paper in this series of white papers.  BSI said of the series that “…we are…producing a series of medical devices white papers. These will keep you up to date with regulations, developments and help you prepare for changes within your industry.”

The other white papers in the series you may be interested in reading, as they are very timely and current, are below:

• Negotiating the innovation and regulatory conundrum
• Engaging stakeholders in the home medical device market
• What you need to know about the FDA’s UDI system final rule
• Effective post-market surveillance; Understanding and conducting vigilance and post-market clinical follow-up
• The proposed EU regulations for medical and in vitro diagnostic devices: An overview of the likely outcomes and consequences for the market
• Generating clinical evaluation reports: A guide to effectively analysing medical device safety and performance

You can sign-up for future white papers or sign-up for their industry sectors newsletter.

If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers or preparing for your Notified Body Audit, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

The old MDD Harmonized Standards Listing used to be located at the website address of http://bit.ly/MDD_Harmonized_Stds_Listing but as of 2 Feb 2015 the site has been archived.  The new site can be found by following the instructions on the archived site.  First click on the link in the bright yellow band on the top of the old site titled “Internal Market, Industry, Entrepreneurship and SMEs website“, then on the new page that opens click on the “Single Market and Standards” link, then on the left hand bar select the link titled “European Standards“, then on the next web page select the link on the left hand bar titled “Harmonised Standards“. Then search for the section titled “Healthcare engineering” and select the applicable medical device directive you are looking for:

• Medical devices (MDD)
• Active implantable medical devices (AIMDD)
• In vitro diagnostic medical devices (IVDD)

If you need help with your EU CE for the Mark Medical Device Directive, the Active Implantable Medical Device Directive or the IVD Directive, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants). 

Just released as of June 25, 2014 this NBRG Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971:2012 is finally available.  Be forewarned that the document is not yet adopted by the NBRG, which can only be done at the next Meeting in October 2014.  Hopefully it will be adopted at that meeting.  I will check in with my NBRG Risk Management Working Group contacts to find out if they know more about that issue.

But let’s take this chance to review a little about the document and the history of the EN ISO 14971:2012 Annex Z’s.  Future posts will get into more details. The following 3 paragraphs come straight from the introduction of the document as the Working Group summarizes the situation really well.  I happen to know a couple of these working group members personally and I know they have a very good handle on the situation and they have provided some very good background.  

In October 2010, the regular review of ISO 14971:2007 which is the basis of EN ISO 14971:2009 was closed by a broad majority of votes confirming the existing status and the wide-spread acceptance of this standard in the medical devices community, including competent authorities. In November 2010, the European Commission raised a formal objection against the use of several harmonized standards, including EN ISO 14971, followed by an in-depth assessment of the coverage of the Essential Requirements of the Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC) by these standards.

As a result of these objections, the Annexes Z to EN ISO 14971 were modified, resulting in EN ISO 14971:2012. This amendment of the EN ISO 14971 standard did not modify the normative parts of ISO 14971:20071. The Annexes Z describe the extent of presumption of conformity that can be based on application of the normative requirements of ISO 14971 alone. The “content deviations”, expressed in the revised Annexes Z, between ISO 14971:2007 and the Medical Device Directives have been commented by many experts in the field of risk management and resulted in diverging interpretations from different stakeholders (e.g. manufacturers, notified bodies, competent authorities).

This document has been prepared as a Notified Body Consensus Paper by a working group headed by the NBRG Vice Chair, with representatives from several European Notified Bodies and industry associations COCIR, Eucomed, EDMA and ZVEI. The paper aims to provide a practical interpretation of these “content deviations” to the Medical Device Directives and give guidance as to how to implement the risk management requirements. The work consolidates prior publications of various sources and is intended to facilitate common understanding between industry and Notified Bodies.

If you would like further info on the consensus document and some history please check out the previous posts below (Latest to Oldest):

• MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012”

• NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation 

• NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012

This post is on the Eucomed Press Release is Pleased with the EU Commissions’s work on the Joint Plan for Immediate Actions for Medical Devices.

On 18 June 2014 Eucomed released a Press Release about a document the EU Commission released on 17 June 2014.  The title of the document is “COMMISSION STAFF WORKING DOCUMENT Implementation of the Joint Plan for Immediate Actions under the existing Medical Devices legislation”.  Eucomed seems to be pleased with the EU Commission on the approach they are taking in this Joint Plan document.  In the press release Eucomed says: “The Commission’s assessment confirms that much needed improvements to Europe’s notified body system have been successfully implemented and are already yielding tangible results.  The Commission also outlines a series of remaining gaps in the system that it believes can only be appropriately addressed in the new Regulation.” The document comes from the Secretary-General of the European Commission and is addressed to the EU Council (Mr Uwe CORSEPIUS, Secretary-General of the Council of the European Union).

The Commission Staff Working Document provides some background about the history of why this occurred (the Joint Plan) and as Eucomed stated this document “outlines system improvements achieved thus far and highlights remaining gaps to be addressed in new Regulation”. The Commission Staff Working Document says: “As an immediate response to the PIP” (Poly Implant Prothèse Company) “crisis” (fraudulently made breast implants)”, the Commission, in February 2012, took the initiative of agreeing with the Member States a Joint Plan for Immediate Actions aimed at tightening controls and at restoring patient confidence in the regulatory system on the basis of existing legislation, pending the adoption by the co-legislator of the new legislation and its subsequent entry into application. 

Two years after the launch of the Joint Plan, this Commission Staff Working Document communicates the achievements of the plan. It also proposes some aspects that should be continued and intensified.” 

The press release from  Eucomed some very positive comments such as: “The conclusions outlined in the….document reflect the collective feedback from Eucomed member companies that Europe’s notified body system is now subject to tightened controls with tangible results such as unannounced audits of manufacturers and notified bodies.” :”Eucomed…welcomes the Commussion’s concrete progress…”

Serge Bernasconi, Eucomed CEO said “The Action Plan very much reflects our recommendation to implement a ‘reinforced control procedure’ rather than turning the system on its head with a complex, costly and overly bureaucratic measure like the ‘scrutiny procedure’ contained in the Commission’s initial proposal and the European Parliament’s first reading agreement.”

In conclusion of the press release Eucomned goes on to say: “Eucomed also welcomes the Commission’s clear delineation in the final pages of their report of the issues that are critical to a strengthened system and must be addressed in the new Regulation, including the obligations of notified bodies, clinical evaluation and vigilance. The European medical device industry also welcomes the Commission’s reference to registries and looks forward to further dialogue on the topic. …Mr Bernasconi said, ‘…perhaps more importantly, in this document they have made clear where there is more work to be done. I am hopeful that the Commission’s emphasis on these points will serve as inspiration to the Council as it continues negotiations towards its position.'”

Below is the conclusion section of the Commission’s Staff Working Document which is what Eucomed was praising in the conclusion of their press release.

Substantial progress has until now been made in the implementation of the plan. In particular the following achievements can be noted:

• Member States have re-assessed the qualifications of the notified bodies in charge of assessing high-risk devices, thus the vast majority of notified bodies. Member States have, in many cases, modified the scope of the activities of the notified bodies;
• A majority of Member States have requested their notified bodies to carry out unannounced audits and have asked notified bodies to ensure they are informed about incident reports. Notified bodies have reported that they are in the process of launching the unannounced audits; 
• Joint audits of notified bodies by teams involving auditors from several Member States and the Commission (FVO) have until May 2014 been carried out in 22 out of 23 countries having notified bodies and is scheduled for the remaining. The voluntary joint audits have been judged as very useful by all parties involved; 
• Two Commission measures, respectively to ensure a consistent application of the criteria to be met for the designation of notified bodies and on the items to be verified by the notified bodies during an audit were adopted in September 2013. The first of the two measures has made the joint audits mandatory for new designations and re-designations of notified bodies. Five such audits have been carried out until April 2014. About 20 mandatory joint audits are foreseen for 2014; 
• Most Member States have reported on their market surveillance activities. This information is used as a base for assessing the need for further improvement; 
• Monthly vigilance teleconferences with Member States, chaired by the Commission services, have been launched and become regular. The teleconferences have proved to be a very efficient means of ensuring/improving coordination between Member States; 
• The Commission Joint Research Centre (JRC) has started a metadata analysis in the field of vigilance reporting and is conducting a screening of publicly available sources with regard to the safety of medical devices relevant for the European Market;
• A Commission Recommendation on the use of a specific system for traceability of medical devices (UDI) was adopted in April 2013; 
• Dialogues with Member States are on-going on product registers; 
• With regard to incident reporting from medical practitioners and patients, Member States however prefer to develop systems at national level.

The positive progress in the implementation of the plan has been discussed between Health Ministers in several EPSCO Councils.

Many Member States and stakeholders have underlined the importance to continue and intensify the work on certain aspects of the Joint Plan. The focus should be on problematic issues identified during the implementation of this plan that are not yet resolved, such as:

• Market surveillance

The information received under the Joint Plan and the national market surveillance programmes indicate great divergences between the Member States with regard to resources attributed and how market surveillance is carried out. Many Member States recognise that because of a shortage of resources, market surveillance is only reactive and that no proactive surveillance is carried out.

These differences in approaches influence decisions on which products are concretely checked and on which aspects they are checked. Experience has shown that national competent authorities sometimes react in different ways to the same problems. A consequence is that whilst in some Member States the placing on the market or putting into service of a given device is banned or restricted, it may freely circulate in other Member States.

Some of the 20 actions for safer and compliant products for Europe outlined in a Commission communication of last year can be a source of inspiration for the concrete actions to be undertaken, in order to address those issues and to develop best practices (for example, a best practice would be to develop a common understanding of market surveillance and better co-ordination and communication on surveillance data, as set out in paragraph 3 of that Communication).

On the international level, the activities carried out within IMDRF could contribute to an increased coordination.

• Functioning of notified bodies

•  Communication and transparency

The next steps on UDI and reporting of incidents from healthcare professionals are foreseen to be taken following the adaption of the new legislation.

The work on making best use of registers for providing data and identifying problems with devices that has been launched under the Joint Plan should be pursued under the current PARENT Joint Action and in follow up actions envisaged.

The proposals of the JRC project on identifying and developing recommendations for mechanisms to detect signals, trends and increased incident frequency more effectively should allow reducing the number of problems at the source and thus more effectively allocate the scarce resources attributed to market surveillance and vigilance. The results, that should become available mid-2014, should allow for discussions with Member States and stakeholders on the improvements in this respect.

•  Sharing of knowledge and good practices

Blog focus BSI’s 2^nd in a series of White Papers for Medical Device & IVD industries, on Generating clinical evaluation reports

White Paper on Generating clinical evaluation reports

This white paper is on “Generating clinical evaluation reports – A guide to effectively analysing medical device safety and performance” and is focused on “…guidance on how to satisfy important regulatory requirements e.g. the concept of equivalence and post-market clinical follow-up (PMCF).”  It is written by Dr Hassan Achakri, PhD, Director, International Clinical Affairs, Zimmer GmbH; Peter Fennema, Director, AMR Advanced Medical Research; and Dr Itoro Udofia, PhD, Orthopaedic & Dental Team Leader, BSI .

I have the distinct pleasure and honor of assisting BSI review this white paper as a member of the BSI Medical Devices White Paper Advisory Panel for this series of white papers.

White Paper Series and Future Topics to Come

BSI says of this series that “Throughout the year, we are going to be producing a series of medical devices white papers. These will keep you up to date with regulations, developments and help you prepare for changes within your industry.”

The additional white papers in the series will be on:

• The digital patient
• What medical device manufactures need to know about FDA’s Unique Device Identification Final Rule
• Post-market surveillance
• Usability engineering

You can sign-up for the whole series of white papers too (further down the webpage on BSI’s website). 

If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).