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

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

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

Changes include:

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

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

Actions to consider:

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

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

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

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.

—————————————————————————————————————–

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.

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

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

o   Changes that will likely affect your current procedures are:

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

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

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

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

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

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

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

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

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

o   Guidance walks you through:

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

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

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

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

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

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

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

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

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

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

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

On October 1, 2011 the DRAFT “FAQ related to Implementation of EN 60601-1:2006 Clarification of open issues” was issued and this DRAFT document is being sent to NB-MED for commenting on the document.  NB-MED is also known as TEAM NB.  This organization is the European Association of Notified Bodies for Medical Devices which covers the MDD (93/42/EEC), AIMDD (90/385/EEC), and IVDD (98/79/EC).  This group publishes guidances that are agreed on by the Medical Device Directives (93/42/EEC, 90/385/EEC, and 98/79/EC) Notified Bodies. Once all the responses are agreed to it is anticipated that the document will be released as an NB-MED guidance document.

The History of this DRAFT document is restated below.  Note that any “click here” links are not live in the below text but are live in the actual DRAFT document.

History

During spring 2011, it was realized that the use of EN 60601-1 and its many family members in demonstrating compliance with the relevant and applicable requirements of the European medical device regulatory framework was not too trivial. While relevant guidance on the matter had been published at the CENELEC website as a Q&A document (click here), some Notified Bodies were giving advice that was felt to be not in line with that guidance. On other occasions, questions were raised that were not covered in the guidance.

So, it was concluded that the situation for electrical equipment in medical practice was not totally clear and that additional guidance would be useful. Further contact with the chair of the NB-MED confirmed this desirability, and a small group of experts was established. This group developed an enquiry asking for “practical issues in the implementation”, that was sent to many stakeholders in June 2011(see Annex 1). Also at the international level of IEC the request was distributed (62A/769/INF).

The response to the request was beyond expectation and the small team of experts, initially consisting of three, was expanded with Dr. Klaus Neuder of DKE (Frankfurt, Germany).

End of July 2011, the work on digesting the issues submitted until then started and it took until end of September 2011 until all material had been thoroughly discussed and answers formulated to the questions that were raised. In some cases, the questions were slightly amended to make them a little more general, and a few additional “connecting” questions were developed by the team.

It is believed that the answers, developed in close team cooperation, present a fair response to the issues brought forward and that they can be used as a reference for all stakeholders.

Now it is time for the NB-MED to scrutinize the proposed responses and see if they are also acceptable to all members of NB-MED. The NB-MED comments are kindly awaited by the end of October 2011, at the same e-mail address that was used for the initial submission of the issues: 60601Ed3.NBMED.issues@gmail.com, using the form supplied together with this document.

Happy reading!

The 60601-1 Issues Team:

Dr. Wolfgang Leetz, Dr. Peter Linders Dr. Klaus Neuder Mr. Martin Schneeberg