Stop the Presses and add these earth shattering Regulations to your reading list for the next week or two:

• Medical Device Regulation (EU) 2017/745 and
• In Vitro Diagnostic Regulation (EU) 2017/746

Bassil Akra of TÜV SÜD some of the costs of this transition in his post on LinkedIn. It ain’t going to be cheap!

Back to our regularly scheduled post:

This Friday 5 May 2017 should be marked in your calendar or journal as a momentous date when the EU Official Journal will publish the Medical Device and In-Vitro Diagnostic Regulations and the transition periods for both start (3 years for the MDR & 5 years for the IVDR)!!  This is the start of a turning point for many medical device and IVD manufacturers as the clock starts ticking away til the end of the transition periods of these new Regulations.  If you haven’t started your transition planning strategies for your products & product families the pressure should be mounting quickly as there is so much to deal with for this transition time. Check out these resources for learning more about the MDR & IVDR. See below for some more details about the challenges you need to consider and START PLANNING for NOW (don’t wait)!

There is no grandfathering once the transition period ends for the applicable Regulation.  So, in 3 years and a day or so if you don’t meet the MDR or 5 years & a day or so if you don’t meet the IVDR you won’t be able to CE Mark your device and sell or distribute your medical or IVD device in the EU (& hopefully the UK which is in the middle of Brexit implications as UK will not be part of the EU by end of transition period).

We have talked about some of the challenges in the implementation of the MDR but here are more details to consider for your strategic planning:

• New definitions to deal with including nanomaterial, Unique Device Identifier, interoperability, economic operator, among other new & modified definitions.
• Person Responsible for Regulatory Compliance: Identify personnel that is  responsible for regulatory compliance with the Regulation and have a minimum work experience in the applicable device field and a minimum of academic qualifications.
• Enormous Single EU Database (not ready yet): Impacts all Economic Operators (which includes manufacturers) – Will register all devices, manufacturers, Economic Operators, CE Certificates, new clinical investigations, & incident reporting.  Will manage all Unique Device Identifications and Single Registration Numbers (SRN).
• Regulations are much more explicit now for the Quality Management System (QMS) & Risk Management System (RMS) requirements.  Beyond just what is in EN 13485 (ISO 1385:2016) & EN 14971
• Economic Operators (new to MDR): Impacts the activities of EU Representatives, Importers, Distributors & Manufacturers – Different Responsibilities depending on type of Economic Operators.
• Traceability of Devices Between Economic Operators: Between all Economic Operators (wow that in itself can be huge!) and all the way down to the healthcare institutions & in some cases down to the patients devices used on.
• Annex I now called Safety & Performance Requirements (not Essential Requirements): Much more prescriptive, addition of UDI & SRN to labelling requirements, all manufacturers will need to update all their Annex I checklists, new Clinical Evaluation & Clinical Performance Evaluations requirements
• Clinical Data: Much more prescriptive especially for higher risk class devices (class III & implantable devices) – Clinical Investigations needed in many cases now & restrictions of the type of clinical data allowed for class III devices (much more restrictive using equivalency data), post market clinical follow-up requirements for high risk class devices (i.e. annual summary reports for Class III & implantable devices).
• Notified Bodies: Much more prescriptive in competency requirements, conflict of interest, designation process, etc.  The end result is fewer Notified Bodies & Notified Bodies with narrower scopes after the designation process.  Also, with the nexus of  the EU regulations, Canada’s MDSAP requirements, and medical device manufacturers transitioning to ISO 13485:2016 the Notified Bodies resources are being strained which means less resources available to the medical device manufacturers. The limited resources means it may be a challenge to complete these processes without hitting the edge or past the transition period so start now or you may not be able to keep all your CE medical devices on the EU market in about 3 years from now when the clock runs out.

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.

This could have a huge impact on the EU market place including the patients, medical device manufacturers (especially the smaller medical device companies), and put jobs at risk, as well.  See the article from Eucamed on a survey they did of medical device companies in Europe to get an idea of the costs involved with these proposed changes.  On 25 Sept 2013 Eucamed said they expressed “…disappointment and strong concern at the outcome of a vote in the European Parliament’s Committee for Environment, Public Health and Food Safety (ENVI)….” in their Article titled Rushed deal leaves patient and jobs in second place.

There are several sources I rely on a regular basis to keep up to date on this changing landscape and the next two websites are some of my favorite blogs as they have very reliable information that is on point, sometimes they will even make a predication here or there (with decent odds of being right, but not always) and always helpful for the medical device manufacturer.

The first of the 2 websites I read regularly is Medical Device Academy.  The article provides analysis and interpretation of how the EU took the next step in approving the proposed medical device regulations. This article covers a lot of ground including the EU Commission Press Release about two new documents in relation to Notified Bodies, Eucamed’s Political Positioning, Next Steps in the Proposed Medical Device Regulations Approval Process (important to read), and lastly Why is there a Rush?

The second website I am always checking up on is MedicalDeviceslegal written by a lawyer that works at a boutique life sciences law firm Axon Lawyers located in the Netherlands who is able to keep a really good pulse of the industry and the development of these types of regulations, laws, directives, and such.  He has written many articles on this specific subject and has been following the process closely.  His latest article indicates that the “ENVI vote result worst of all worlds”.   He gives you the bad news straight up.

Other resources I rely on a pretty regular basis that also have articles on this subject are: 

• RAPS Regulatory Focus which has 2 articles for today 26 Sept 2013 on the subject:
• European Parliament Passes Landmark Medical Device, IVD Reform Proposals
• European Commission Strengthens Oversight of CE-Marking Process
• MASS DEVICE article I saw today on the topic but with other related articles from other days:
• EU panel approves FDA-like requirements for medical devices
• Fierce Medical Devices one article I saw today but with other related articles from other times:
• EU committee backs tougher, U.S.-style device approval system

On 15 Jan ’13 the FDA issued a notice in Federal Register for the Recognition List # 30.  The notice in the Federal Register said: “FDA maintains the Agency’s current list of FDA recognized consensus standards in a searchable database…FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary.”

Other resources that you can find out more about this subject:

RAPS Regulatory Focus article of 15 Jan 2013

CDRH’s Standards Program / Standards Management Staff webpage

 On 24 Jan ’13 the Official Journal of the European Union published updated lists of Harmonized Standards under their respective Directives for the:

MDD (OJ published updated list of Harmonized Standards) and the consolidated list of Harmonized Standards*

AIMDD (OJ published updated list of Harmonized Standards) and the consolidated list of Harmonized Standards*

IVDD (OJ published updated list of Harmonized Standards) and the consolidated list of Harmonized Standards*

* – All of the consolidated lists of Harmonized Standards have a note that indicate that these are for reference only and are not the legal documents.  A repeat of the note for these Directives is below:

“The summary list hereunder is a compilation of the references of harmonised standards which have been generated by the HAS (Harmonised standards) database. This IT application HAS automates the process of the publication of the references of harmonised standards in the Official Journal of the European Union. Although the list is updated regularly, it may not be complete and it does not have any legal validity; only publication in the Official Journal gives legal affect.”

First a closing statement press release from the GHTF president was issued recently (dated Nov 2012) and on the International Medical Device Regulators Forum (IMDRF) webpage for the Archived GHTF documents there is a statement at the top of that page stating:

• “Important! The organisation GHTF no longer exists, and has been permanently replaced by the IMDRF. All material appearing on this page and the pages within has been moved here from the old GHTF site for preservation, and is no longer current. It is historic information and should not be acted upon.”

Another point to note is that the last set of documents from the GHTF were issued on 2 Nov 2012 and the IMDRF website in the last couple days seems to have been totally updated and reorganized in an easy to use format that will make it easy for the public to view this valuable resource and to stay up to date on the happenings of this organization.   Hopefully,  in the next decade, or sooner, the IMDRF will begin the process of Harmonizing areas of the international medical device regulatory arena so medical device manufacturers won’t have to deal with varying regulations through out the world.

On the Archived GHTF webpage it also states that they have brought all of the current and archived GHTF documents over to the IMDRF website.  Note, that the GHTF website is still up but it is not clear what will happen to it or when it will be taken down.

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More about the IMDRF: Straight from the IMDRF website the following gives you some information about the organization.  If you have furhter questions about the organization please contact the IMDRF secretariat at imdrf.secretariat@tga.gov.au

IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence.

IMDRF was born in October 2011, when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa to address the establishment and operation of this new Forum. A copy of the outcome statement from this meeting is available from the Meetings page.

Further information about the work and operations of IMDRF is available in its Terms of Reference (Note, the last page of this document has an organizational chart showing the roles and inte-relations of these roles).

On the About Us webpage  they go on to describe the different roles and responsibilities within the IMDRF.   The functions described are the IMDRF Management Committee; the Management Committee Members (Australia, Brazil, Canada, Europe (the EU), Japan, and the USA);  Official Observers (World Health Organization {WHO}); Affiliate Organizations; and Working Groups.

RAPS Regulatory Focus Article posted 30 Oct 2013 on the subject is interesting and provides some additional background and perspective.

The Emergo blog posting says “While the European medical device regulatory system remains largely intact, greater detail has been added, and new mechanisms exist to bolster the weaknesses.” An example, is that in the existing MDD there are only 14 definitions while in the proposed Regulation there are now 50 definitions.  As you can see from this example the intent is to clarify the regulation so it is better understood. The Emergo blog post summarizes the high level primary changes while the Emergo White Paper goes into a much deeper analysis.

If you are interested in consulting support  from Eisner Safety Consultants to help you through this transition, closer to when finalized, or for current MDD or AIMDD please feel free to contact us via the information at our contact us webpage.

You don’t have to leave your office to join in on the presentation and as a special thank you for visiting us at Eisner Safety Consultants you can get a 20% discount.  To find out more about the presentation & discount just click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

The post on this Commission Regulation (EU) No 722/2012 is thx to Erik Vollebregt who blogs on EU legal and regulatory developments of medical devices.  Erik has provided content previously to our blog and we thank him for his generosity in allowing us to post his content.

The Notes and summary of the Report are repeated below:

Notes:

The report is written with a multiplicity of audiences in mind. First and foremost it is intended to inform the Management Board of the European Chemicals Agency (ECHA) and the Competent Authorities on REACH And Classification And Labeling (CARACAL) of the work of the DCG. It is though also intended to provide a transparent account to other interested parties, in particular national and EU industry organisations and their members, non governmental organisations representing workers, consumers and the environment and similar organisations in third countries interested in REACH and CLP.

This report has been agreed by the members of the Directors’ Contact Group.

Summary

The adoption of Regulation (EC) No 1907/2006 of the European Parliament and the Council on 18 December 2006 concerning the Registration, Evaluation and Authorisation of Chemicals (REACH) marked a milestone in the modernisation of the European chemicals legislation. REACH is widely recognised as being the most ambitious and comprehensive piece of chemicals legislation in the world.

REACH set 30 November 2010 as the deadline for all manufacturers and importers of high volume substances and substances of particular concern to register their chemicals, thus subjecting a large proportion of the volume of chemicals on the EU market to the REACH rules.

Recognising that fulfilling the REACH requirements by this deadline would present significant challenges to industry, the Commission invited six industry organisations and the European Chemicals Agency (ECHA) to nominate members to and thereby set up the Directors’ Contact Group (DCG). The purpose of the DCG was to monitor progress towards meeting the first registration deadline and to reduce practical obstacles to registration identified by industry.

In the course of 2010 the DCG identified and addressed in total 28 issues, contributing to the successful completion of registration by the first deadline. The practical co-operation between the Commission, ECHA and industry associations therefore proved successful, demonstrating that obstacles to registration can be reduced. This clear learning from the efforts in 2010 made the Commission decide to continue the work of the DCG with the aim of continuing the registration success story through the next major registration deadline of 31 May 2013.

‘Stakeholders can send their comments by 8 August 2011.

The Eucomed Alternative Labeling Task Force will meet on 1 July 2011 to analyse this latest version of the proposal, which was previously extensively discussed with the European Commission during its initial development.

For more information on the Eucomed Alternative Labeling Task Force or if you have any questions, please contact Dario Pirovano (Dario.pirovano@eucomed.org).‘

Draft regulation on Electronic IFU for medical devices.