The Medical Device Coordination Group (MDCG) is meeting on March 11 & 12th to hold a series of meetings. Part of these meetings includes hearing feedback from industry and Notified Bodies on stakeholder preparedness for the application of the MDR on 26 May 2020.

Some of the topics to be discussed include:

• Updates on MDCG Subgroups
• MDR/IVDR Implementing Acts
• Commission’s Progress report on Notified Bodies designation process under MDR /IVDR
• EUDAMED db – state of play
• Expert Panels – State of play on setting up of Expert Panels

The MDCG will discuss three transitional provisions:

1. Guidance on significant changes [Art. 120.3 (EU) 2017/745] with regard to devices covered by certificates according to 90/385/EEC or 93/42/EEC – for endorsement
2. Class I transitional provisions in Article 120 (3)(4) – for endorsement
3. Guidance on transitional provisions for consultations of authorities on devices containing ancillary medicinal products and on devices manufactured using TSE susceptible animal tissues – for information

Additionally, some interesting topics include:

• Discussions on the developments with regard to guidance on MDSAP (Medical Device Single Audit Programme)
• EU Participation in the IMDRF (International Medical Devices Regulators Forum)

Draft Agendas are available here: 11 March 2020 – MDCG (MDR/IVDR) High Level – Draft Agenda, 11-12 March 2020 – MDCG (MDR/IVDR) – Draft Agenda, and 12 March 2020 – Meeting between MDCG & Stakeholders MDCG (MDR/IVDR) – Draft Agenda

Need help with regulatory, MDR, quality, or compliance support with IEC 60601 series of standards support please schedule a call.

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).

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).

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

BSI recently updated the white paper on Proposed EU Regulations for Medical Devices & IVD’s to reflect the latest EU vote in early April, enabling the commission to move forward with the legislation.

Refer to the previous blog post on BSI White Paper on Proposed EU Regulations for Medical Devices & IVD’s for additional details about the white paper and the Series of white papers.

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).

9 April 2014 – Today marks the beginning of a series of white papers that BSI has just released.  

White Paper on Proposed EU Regulations

This initial white paper is on the “The proposed EU regulations for medical and in vitro diagnostic devices” and is focused on “An overview of the likely outcomes and consequences for the market”.  It is written by some of the best authorities in the business, on this subject, Gert Bos of BSI Head of Regulatory and Clinical Affairs and Erik Vollebregt Partner at Axon Lawyers, that I personally know and trust. 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.  

BSI states that this white paper reviews “the proposals for the new medical devices (MDR) and IVD regulations (IVDR) will provide a new regulatory framework for medical devices in the EU for the coming decades. Although crucial elements of the regulations are still subject to political debate, one thing is clear – the regulations will cause important changes for you. Use this white paper to find out how to prepare for these changes.”

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:

• Generating clinical evaluation reports: A guide to effectively analyzing medical device safety and performance
• 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).