What to do? No worries! You just need to know where and how to look for them. Easy as 1, 2, 3!!!

First, go to the Harmonized Standards website to pick the applicable Directive as you have in the past.

Next, select the applicable Directive which I will use the MDD for this example. Click on the link near the bottom of the page just below the box that says “Publication in the Offical Journal”, as noted below.

Finally, you end up on the list of Harmonized Standards that are published in the Official Journal of the EU. This was the intention of the EU Commission. I asked an associate at the Commission recently what happened to the easy to use HTML listings on the Directives webpages and his response was “Maybe you were looking for the list in html format, but they are no longer published in that format on the sectorial standardisation pages, to prevent any possible discrepancy and confusion with the lists as published in the OJEU, which are the sole valid lists by a legal point of view.” So, there you have it. The OJEU list in pdf or HTML (but the formatting is horrible) can be accessed. I would stick with the download of the pdf version or the OJ version which in this case has the 3 Directives (MDD, AIMDD, & IVDD) altogether, in the language of your choice.

Need help with identifying “State of the Art” Standards for the Medical Device Regulation (as no Harmonized Standards exist yet for the MDR) or for other country requirements. Leo is on many of the standards writing committees including the IEC 60601 series, ISO 15223-1, AAMI CR 507 & COVID-19 Response Team, & CB Scheme ETF-3 Risk Management Group. Feel free to schedule a call with Leo www.EisnerSafety.com/Schedule-Call/ or contact Leo at Leo@EisnerSafety.com.

Since our original post (below) we have made 3 additional updates to provide you with a lot more info and resources.  Check out our updates in this LinkedIn Article.

Updates are all underlined:

Mar 7, ’17 updates:

* addition of the EU Council vote & date of release of final text

* an important change that manufacturers will need to deal with, and

* addition of 4 resources to list of helpful resources

Mar 12, ’17 update: add in Table of Contents LinkedIn Article

Mar 17, ’17 update: RAPS Article by Rod Ruston

Our original post was on March 1, 2017 is titled EU MDR & IVDR – Final Versions – Are You Ready, Transition Period Starts Soon.

If you need help with your EU MDR or IVDR transition planning please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants.

Some of the changes manufacturers will have to deal with include:

*Quality Management Systems
*Clinical Evidence Requirements
*Authorized Representatives Requirements and Liability
*You may need to change Notified Bodies if their scope changes during the designation process
*Need to prepare and implement for Unique Device Identifiers (UDI), starting with the highest risk class
*Person responsible for regulatory compliance in your company – minimum requirements
*Classification rules will change & some devices that are not considered medical device currently will fall under the MDR
*Classification rules will impact IVDs significantly under the IVDR
*Updates to post market surveillance & vigilance requirements
*Economic operators in the supply chain will have some changes to the obligations per the MDR or IVDR

Here are some resources to share with you:

greenlight.guru Webinars on How to Prepare for the New EU Medical Device Regulations (MDR) and How to Prepare for the New EU In Vitro Diagnostics Regulations (IVDR)

For the following 3 BSI White Papers* please select the title from the BSI White Paper webpage.

BSI’s white paper* on the MDR “Planning for implementation of the European Union Medical Devices Regulations – Are you prepared?”

BSI’s white paper* on the IVDR titled “How to prepare for and implement the upcoming IVDR – Dos and don’ts”

BSI’s white paper* on the MDR & IVDR draft text (article updated Oct 2015) titled “UPDATED: The proposed EU regulations for medical and in vitro diagnostic devices”

BSI webpage for white papers* has additional white papers on medical devices / IVDs and quality system requirements.

One of my favorite blogs to follow on the MDR changes is Erik Vollebregt’s Medicaldeviceslegal.com blog.  Erik does an excellent job providing really great information on the subject and keeping his finger on the pulse of the issue at hand.

* Note, through out the BSI White paper series I have had the honor of being on the Advisory Panel to help shape the series and review each of the white papers to provide my years of experience in the medical device industry and the regulatory world.

De-notification of EU Notified Bodies under MDD

The number of EU Notified Bodies (NBs) under the MDD has dropped from about 80 to less than 60 because of the increasingly more stringent NB requirements.  Are you sure your Notified Body scope still covers your products or are they de-notified?  The French Competent Authority (National Agency for Safety of Medicines and Health Product [ANSM]) in late 2016 published an Information Bulletin.

Also, what is going to happen when the Notified Bodies apply for designation under the MDR and when will your Notified Body get approved for the designation under the MDR.  The designation process may take a year or more and some NB’s may not get designated for all they expect or they may decide to shutter their doors, among other scenarios.  So, make sure to read the notifications in the above paragraph and also stay in close contact with your NB to make sure you don’t get left in the cold without a proper NB for your product lines.

If you need help with your EU MDR or IVDR transition planning please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants.

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).

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 a status update on the NBRG RMWG Risk Management Consensus Document

30 April 2014 – The NBRG (Notified Body Recommendation Group) Risk Management Working Group (RMWG) membership will have a face to face meeting in mid May to refine the draft Consensus document on EN ISO 14971:2012.  This meeting has come about because the NBRG RMWG received some feedback recently from the EU Commission and they will consider it and roll it into this document.

The consensus document’s purpose is to reduce the confusion around the EU Harmonized Standard EN ISO 14971:2012 Annexes ZA, ZB, & ZC that amends the EN ISO 14971:2009 version of the standard to align with the 3 Medical Devices Directives (the Medical Device, Active Implantable Medical Device, and In Vitro Diagnostic Medical Devices Directives). The previous plan was to have this Consensus document completed and released by Mid to Late April ’14 but at this point it is hoped the NBRG RMWG will have a final released document by the end of June 2014. We look forward to sending good news about the progress of this document over the next month or so.

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

The NBRG (Notified Body Recommendation Group) Risk Management Working Group is working to put together a consensus document.  A call to industry has been sent out to ask for participation in a survey on how your risk management system aligns with EN ISO 14971:2012 that will help in the direction of this consensus document so please take part in it.  Read the article for more details and a post that links to the survey.

Past posts on this subject include:

• 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

If you need help with Risk Management with respect to the IEC 60601 series of Standards, 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 live link to the survey is on the fourth set of pages on slide deck and is slide 8 of the presentation.  The more participants in the survey the more likely your voices will be heard and we hope this will improve the potential outcome of the process.

On 8 February we posted the NBRG letter which was a Call for Industry Participation in the Survey on Understanding Annex Z of EN ISO 14971:2012. 

[slideshare id=32021997&doc=mdmwestpresentationonnbrgconsensusdocumentoneniso14971201211feb2014-140306235842-phpapp01&type=d]

On 7 February 2014 the Vice Chair of the Notified Body Recommendation Group, Michael Bothe, sent out a letter to industry to ask for their participation in a short survey (about 10 minutes long) to help the Notified Bodies understand what are industry’s current practices when it comes to conducting Risk Management Process on their medical devices and IVD’s and how it relates to EN ISO 14971:2012.  As the letter says it is to “attempt to develop a practical interpretation on how to use and implement Risk Management in the context of the European Medical Devices Directives, more specifically the European version of ISO 14971:2007, as published in EN ISO 14971:2012.”

Please join in on this survey, as the more participation the more representative the data will be to the Notified Bodies and hopefully this will make for a better Consensus Document on EN ISO 14971:2012 Risk Management Process.  Please complete your survey responses by 21 March 2014.

To find out more about what is going on with this proposed Consensus Document please join me, Leo Eisner as the track chair for Improving Risk Management Strategies and Procedures, at the MD&M West conference on Tuesday 11 February 2014, as I discuss how we got to this point and what is hopefully going to culminate in a Consensus Document on Risk Management with regard to EN ISO 14971:2012.

If you have questions about this topic or need help with compliance with your Medical products you can e-mail Leo Eisner at Leo@EisnerSafety.com directly or call Leo at 503-244-6151.  Leo is the Principal Consultant of Eisner Safety Consultants.

On 30 April 2013 the Medicaldeviceslegal.com website via Axon Lawyers posted a really helpful new document for your use (free of charge and no request for info about you or your company).   The RAPS Dutch/Flanders chapter has been active in defining a list of EU legislation that does not directly regulate medical devices but covers them in its scope, like environmental design requirements for electronic devices.  From this listing Axon Lawyers expanded the document into an English language document that includes active links to the underlying legislative texts, the EU law summaries in the ScadPlus database, if available, and to the EU Commission web pages with explanation about the rules concerned.

Axon Lawyers mentioned that this list will always be in constant flux because these rules tend to be amended a lot.  So, the best place to download this chart is directly from their blog posting.  If you want to just download this version of the chart click here for now but check back with their website (Medicaldeviceslegal.com) to look for updates.  At this point they haven’t decided how they will distribute updates to this chart but I am sure they will figure something out and disseminate, as appropriate.  Stand tuned for more updates on this valuable resource and let’s again thank both the RAPS Dutch/Flanders chapter and Medicaldeviceslegal.com website for this resource they are sharing with us.