European Commission – Press release

Medical devices: European Commission asks for further scientific study and draws first lessons from the recent fraud on breast implants

Brussels, 2 February 2012 – Following today’s publication of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the safety of silicone products manufactured by the Poly Implant Prothèse (PIP) Company, the European Commission requested to conduct further in-depth study on the potential health impact of faulty breast implants.

The Commission will also discuss with the Member States how surveillance of the medical devices can already be reinforced immediately within the existing legislative framework. In parallel a “stress test” of the legislation on medical devices is under way in order to identify how best the questions raised by this issue can be addressed in the revision of this framework already foreseen for 2012.

Health and Consumers Commissioner, John Dalli said: “In the current situation, patients’ health remains the priority. The opinion published today sums up the current scientific knowledge on this case”. To add : “Furthermore, the Commission will discuss with the Member States a series of immediate measures to strengthen the existing surveillance and safety controls on medical devices already on the market. The capacity to detect and minimize the risk of fraud must be increased”. To conclude : “We had already been working on a revision of the Medical Devices Directive, envisaged for adoption  this spring.  We will now also take into account the lessons learnt from this case and take them on board in redrafting our legislation, in particular with regard to market surveillance, vigilance and functioning of notified bodies.”

Scientists concluded that data available today was insufficient to lead to firm conclusions regarding the health risk for women with PIP silicone breast implants.

The SCENIHR report (requested by the Commission in early January) stresses that, based on the limited data currently available, there is some concern regarding the possibility of inflammation induced by ruptured PIP silicone implants. The report concludes that each case needs to be assessed individually, so the advice remains that women who are worried should contact their surgeon.

Scientists also recommend that further work be undertaken as a priority to establish with greater certainty any health risks associated with PIP silicone breast implants, in order to ensure that potential risks are properly established, quantified and managed.

With regard to the question of whether the breast implants manufactured by PIP are more prone to failure than those of other manufacturers, SCENIHR said that PIP implants have been found to vary considerably in composition and as a result are likely to vary substantially in performance characteristics.

SCENIHR concluded on the basis of available data, that many PIP implants were manufactured from non-medical grade silicone. This type of silicone may contain some components that can weaken the implant shell and diffuse into the body tissues.

Next steps

First, the European Commission will ask the Scientific Committee to pursue a more in-depth investigation based on data from investigations by Member States.

Second, the Commission will discuss with the Member States how surveillance of the medical devices can be reinforced immediately within the existing legislative framework. These issues could include further recourse to unannounced inspections, enhanced controls of notified bodies and additional sample testing on products already on the market.

Third, the Commission is also conducting a stress test in order to identify how best the questions raised by this issue can be addressed in the upcoming revision of the legislation on medical devices which was already underway. The Commission still envisages adopting a proposal on the revision of the Medical Devices legislation in the course of this semester.

National health authorities in the Health Security Committee convene by audio conference today to discuss the follow up to the Opinion.

Background

Breast implants fall under the European legislation on medical devices1. This legislation requires that, before placing such devices on the market, the manufacturers must carry out an assessment to ensure that their devices fulfil the relevant legal requirements, and in particular that their devices will not compromise patient safety. For high risk devices, such as breast implants, a third party conformity assessment body, so-called notified body, is involved in the conformity assessment procedure.

In the present case, an investigation triggered by an unusually high short-term breast implant rupture rate has shown that a manufacturer (Poly Implant Prothèse Company) fraudulently made use of industrial silicone instead of the approved medical grade silicone. The product was withdrawn from the EU market in 2010.

On the basis of available data, it is estimated that around 400 000 PIP silicone breast implants were sold worldwide. These implants were available in nearly all European Union Member States – in particular they were widely used in the United-Kingdom, France, Spain and Germany, where respectively around 40.000, 30.000, 10.000 and 7.500 women were implanted with PIP silicone breast implants.

Work of the SCENIHR

SCENIHR is an independent advisory body established by the Commission. Its members are chosen on the basis of scientific excellence and they advise the Commission on issues associated with new and emerging health risks.

The current rapid opinion drew on top international scientists’ expertise in fields of plastic surgery, polymer science, senology and medical epidemiology.

To see the full scientific opinion on the safety of PIP breast implants, see

http://ec.europa.eu/health/scientific_committees/emerging/index_en.htm

Link to Medical Devices Directive:

http://ec.europa.eu/health/medical-devices/regulatory-framework/index_en.htm

1 :
OJ L 169, 12.7.1993, p. 1

The UK MHRA has updated their website to be much more functional and you can find a lot of information about the Directives (i.e. MDD, IVD, & AIMDD) related to the medical devices. Also, you can find the UK transposed regulations and many other useful items such as classification information, borderline documents, the conformity assessment process, regulatory news, details on revisions of the MDD, Vigilance, Notified Bodies, and much much more. The site links you to multiple places to the Europa website for things such as the Interpretation & guidance documents and more…

If you are looking for information on Medical Devices under the MDD this is a good link to look at for lots of information on the subject.

If you are looking for information on Medicines legislation & directives this is a good link to look at for lots of information on the subject.

They even set-up a page for New Technologies Forums for both Medicines and Medical Devices.

Final publication and entry into force is expected at the beginning of 2012.”

Just received an e-mail update on the status of the DRAFT NB-MED document on 3rd edition of EN60601 Implementation for the EU. The pertinent points are:

1) Substantial progress has been made over the last couple months on the document

2) The NB-MED has presented their observations and comments on the proposed document to the team proposal early in Dec 2011

3) The team has worked on integrating the observations and responding to the comments

4) on 13 Jan 2012 the group forwarded their results to the NB MED working group for their approval (validation).

5) It is expected that this document will formally be published hopefully within a couple of weeks not months.

For more details on this DRAFT document please go to http://wwww.EisnerSafety.com/draft-results-implementation-of-3ed-en60601-series-for-ce-marking/ for a copy of the DRAFT document and
http://www.eisnersafety.com/eu-en-iec60601-1-3rd-ed-request-for-issues-on-the-use-of-the-std-for-ce-conformity/ for the first announcement about this process.

Innovation Pathway

Background on CDRH Innovation

On Feb. 8, 2011, the FDA’s Center for Devices and Radiological Health launched its Innovation Initiative, which proposed actions the agency could take to help accelerate and reduce the cost of development and regulatory evaluation of innovative medical devices in a way that maintains or improves patient safety and is based on sound science.

As part of that Initiative, the FDA proposed the Innovation Pathway, a priority program for technologies that address unmet medical needs in disease treatment, diagnosis and health care delivery. The FDA also announced a pilot submission — a brain-controlled, upper-extremity prosthetic — for review under the Pathway.

After considering public comments received on the Innovation Initiative — and extensive review of our experience from the pilot submission, the FDA is introducing the Innovation Challenge, a call for voluntary submission of innovative device applications for End-Stage Renal Disease (ESRD).

Regulatory decisions that improve patient access to safe and effective,
 innovative medical devices

Developing a New Approach to Device Review
Background on CDRH Innovation

Bringing breakthrough, safe and effective medical devices to patients quickly, safely and efficiently improves lives and health care. To help reach patients with these devices as quickly as possible, the FDA created the Innovation Pathway — a priority program for technologies that address unmet medical needs in disease treatment, diagnosis and health care delivery.

The Innovation Pathway aims to shorten the overall time it takes for the development, assessment, and review of breakthrough medical devices. Some key areas of focus include the development of new decision tools to help the FDA assess and characterize benefits and risks to patients, and new collaborative ways for the FDA and innovators to share ideas about new device concepts. Where applicable, these new approaches, practices, and tools will be used in other pre-market programs.

Developing a New Approach to Device Review

Developing the Innovation Pathway is an evolving process that entails the FDA approaching medical device review using new paradigms — rapidly testing them, applying what works and learning from what doesn’t. A team of experts are analyzing each step of the premarket pathways for medical devices and exploring ways to bring about more patient-centric, predictable and swifter decisions that can also address the unique scientific challenges that innovative technology often brings. The team has begun developing new tools and processes, including:

• A decision-framing tool to help reviewers and sponsors quickly determine product classification and regulatory direction;
• A decision-framing tool to help reviewers and sponsors determine requirements for first-in-human clinical trials; and
• A collaborative workspace where FDA staff, medical device developers, patients, scientists and industry can discuss the technology, intended use and the unmet public health need.

These tools, and others in development, present the FDA with the opportunity to commit its time and resources much earlier in product development. By front-loading these resources, the FDA can identify and resolve new scientific and regulatory challenges that may accompany an emerging technology that raises new or novel scientific questions. As a result, patients will receive safe and effective products more quickly and device makers can bring important technologies to market more predictably, faster, and at a lower cost.

In order to use and evaluate the new tools and processes, the FDA is inviting innovators who have ideas for medical devices that diagnose or treat End-Stage Renal Disease (ESRD) to volunteer for our Innovation Challenge. When proven successful, the FDA plans to integrate these new approaches into its other premarket programs when applicable.

Additional Information

• Driving Biomedical Innovation: Initiatives for Improving Products for Patients
• Medical Device Innovation Initiative White Paper
• Public Workshop: Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development, June 24, 2010/li>

Check it out here

In the Eucomed 18 Nov 2011 newsletter article they say “In March 2011, the regulatory authorities of the … GHTF took the decision to disband the GHTF … to be replaced by a ‘regulator-led harmonisation and collaboration group.’ … regulatory authorities felt that it was time to change the way the GHTF was operating so as to accelerate international medical device regulatory harmonisation.

For more details see the Eucomed newsletter article.

In the Federal Register Notice the FDA said “The agency believes that this wil allow adequate time for interested persons to submit comments without significantly delaying action by the agency.”

Per a Mass Device web article of November 8, 2011 “The draft guidance is intended to update a 1977 guidance document, ‘Deciding When to Submit a 510(k) for a Change to an Existing 510(k).’ It aims to clarify when a new 510(k) pre-market notification should be submitted for a change or modification to a device that’s already won 510(k) clearance.”

There is a video demonstration of the CardioTeach™ iPad app

Apple AppStore iPad link for the CardioTeach™

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

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.

The recast of the Restriction of Hazardous Substances (RoHS) Directive has been released as 2011/65/EU.  You can read the directive at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF.  With the exception of the items listed in Article 2.4, the RoHS Directive applies to all Electrical & Electronic Equipment.

As an overview:

-   Scope:

• • Medical devices (per 93/42/EEC) and IVD devices (per 90/385/EEC) are now included.  They are both part of the general group called “medical devices” in the directive.
  • Active implantable medical devices remain excluded from the requirements of the directive.

-   Limits: The maximum concentrations in homogenous materials are limited, by weight:

• • Lead (0.1 %)
  • Mercury (0.1 %)
  • Cadmium (0.01 %)
  • Hexavalent chromium (0.1 %)
  • Polybrominated biphenyls (PBB) (0.1 %)
  • Polybrominated diphenyl ethers (PBDE) (0.1 %)

-   Transition: Devices must bear a CE mark and have a declaration of conformity for the RoHS Directive from

• • 22 July 2014 for Medical Devices.
  • 22 July 2016 for In-Vitro Diagnostic Medical Devices.

NOTE:  A single CE mark and declaration are acceptable.  (You will need to explain the dual meaning of the CE mark in the instructions for use and clarify that, if used, the Notified Body number only applies to the MDD or IVDD related issues.)

-   Exemptions:

• • Cables and spare parts needed for the repair or reuse of devices may continue to be distributed for devices placed on the market prior to the transition date.
  • Exemptions available to all devices are listed in Annex III.  Specific exemptions for medical devices are listed in Annex IV.
  • Exemptions for medical devices will be valid for up to 7 years.
  • Requests for exemptions:

• • • Will be filed with the Commission and include all information listed in Annex V.  Most notably, the request must include an analysis of possible alternative substances, materials or designs.
    • Renewals must be requested at least 18 months before the existing exemption expires.
    • Applications for exemptions will be accepted for medical devices even before the RoHS Directive is fully transposed (2JAN2013) if an overseeing Notified Body certifies that the safety of potential substitute has a clear negative socioeconomic, health and consumer safety impacts.

-   Labeling: The labeling requirements are likely already addressed by MDD or IVDD requirements.  However, you should review the requirements in Articles 7.g, 7.h9.d and 10.a to confirm.

–   Record Retention:

• • Records must be retained for 10 years after a device is placed on the market.  Note that this may be longer than required by the MDD or IVDD.
  • Records to retain include:
    • Technical documentation confirming compliance with the RoHS Directive and a register of non-conforming product and product recalls,
    • List of any economic operator (manufacturer, authorized representative, importer, distributor) who has supplied you with electrical or electronic equipment, and
    • List of  any economic operator to whom you have supplied any electrical or electronic equipment.

If you would like to see some additional information on some of the areas, in the future, that may be implemented refer to the  BSI article that is posted on our website.

Our group (Eisner Safety Consultants) has worked with a select set of service providers that can obtain the CofC’s or the total composition information for each component and in turn the full product composition.  Please feel free to contact me, Leo Eisner (Leo@Eisnersafety.com) if you have any questions on this subject and I would be more than happy to assist you.

Please contact us if you have questions or concerns.

The draft guidance document states in section IV: “This guidance explains FDA intentions to apply its regulatory requirements to a subset of mobile apps. This subset, which we are calling mobile medical apps as defined in section III (definitions), includes only those that meet the statutory definition of a device; and either:

• are used as an accessory to a regulated medical device;
• or transform a mobile platform into a regulated medical device.

This guidance does not specifically address wireless safety considerations, classification and submission requirements related to clinical decision support software, or the application of quality systems to software. The FDA intends to address these topics through separate guidance(s).”

Also, the draft guidance details a long list of app’s that don’t fall under this draft guidance document.

The following text has been taken straight from the Health Canada website on the page for this final guidance document

“A draft version of this guidance document was first published and released for consultation in 2006. Comments from stakeholders and the Scientific Advisory Panel on Reprocessing of Medical Devices have been considered in producing this final version.

To reduce the risks associated with the use of reprocessed reusable medical devices, Health Canada has developed this guidance document to aid manufacturers of Class I, II, III and IV reusable medical devices in the preparation of reprocessing and sterilization information to be provided with these devices.

The guidance document is intended to assist manufacturers in understanding and complying with the regulatory requirements of section 21(1)(i) of the Medical Devices Regulations as they pertain to the directions for use for reusable medical devices. This guidance document should be used in conjunction with the Guidance Document on Recognition and Use of Standards under the Medical Devices Regulations.

In order to provide industry with sufficient time to meet the specifications of the guidance document, Health Canada will allow a six-month transition period commencing on the date of implementation, June 1, 2011. Following the transition period, Health Canada will expect manufacturers to meet the specifications listed in the guidance document.

Further information on this guidance document, and a summary of comments received and Health Canada’s responses to them, may be obtained by contacting:

Device Evaluation Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Phone: 613-954-0297
Fax: 613-957-9969
E-mail: DED_manager@hc-sc.gc.ca

Published by authority of the Minister of Health

Date Adopted 2011/06/01

Effective Date 2011/06/01

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.”

E-Submissions Coming for Medical Device & Pharmaceutical Manufacturers http://ht.ly/5y1ZQ

‘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.

I would like to also thank Martin Schneeberg & Peter Linders for allowing me to share this with all my clients and website visitors.

Implementation of EN IEC 60601-1 3rd edition

Request for Issues

on the use of the standard for CE-conformity purposes

When the transition period was defined for EN IEC 60601-1:2006 (replacing the 1988 version with its two amendments), several questions arose. These questions were included in a FAQ document that was posted at the CENELEC web site (click here) to give all users the same interpretation[1]: (click here).

The transition period, after which only the 2006 edition will be giving presumption of conformity with the relevant Essential Requirements of the Medical Device Directive (93/42/EC), is now well underway. As an increasing number of manufacturers are implementing this version of the standard, more questions come up. In particular this is the case in conversations between manufacturers and involved authorities or Notified Bodies considering CE-conformity purposes.

In an attempt to support these discussions, and to harmonize responses, we are looking for specific matters that have arisen and that may have wider relevance. Together with regulatory experts, we will seek answers to those matters that reflect a consensus opinion of the Medical Notified Bodies. Clearly, this is not a request for technical matters, e.g., for required test conditions, but rather unclear situation. A few examples of such matters are given in the annex.

If you know of such matters, or even have experienced some yourselves, please share these. If you have reached agreement on these matters or you have proposals for the same, and wish to share: these are also very welcome. As indicated, the matters will be compiled and given to experts for sound advice, followed by scrutiny from NB-MED experts, resulting in the best available recommendations for the matters indicated. This advice will be made publicly available.

Please submit your contributions to: 60601Ed3.NBMED.issues@gmail.com. Note that not all contributions may receive individual responses. We will start work with material submitted by 30 June 2011, yet contributions after that date remain welcome. We expect first results by 30 September.

Thank you for your consideration and valuable contributions.

Martin Schneeberg (TÜV SÜD PRODUCT SERVICE, member of UK 811.1, IEC TC62A, WG14, MT28, A1PMT, IECEE RM TF)

Wolfgang Leetz (Siemens AG, Healthcare Sector, chair of DKE Division 8 (electro medical equipment, electro acoustic, ultrasound, laser), chair of COCIR Standardization Policy Focus Group)

Peter Linders (Philips Healthcare, chair of CENELEC TC 62, chair of COCIR Technical and Regulatory Affairs Committee, member of IEC/TC 62 CAG, A1PMT)

Annex – Examples of questions sought

Q1. Valid EC Design-Examination certificate period vs. DOCOPOCOSS: 2012-06-01:
Example: Suppose an MDD class IIB or III electrical medical equipment was placed on the EEA in 2009. It has a signed EC Design-Examination Certificate by a NB based on 2Ed EN 60601-1, valid until 2014-01-01 (five years).

Question: Is this product affected by the DOCOPOCOSS related to EN 60601-1:1990 (+ am1 + am2), June 1st 2012? Keep in mind that a valid EC certificate has been issued by a NB which is valid 5 years up to 2014.

Q2. Future totally new particular standards:
For a specific MEE does not exist a specific particular standard related to 2Ed EN 60601-1. However, for this specific MEE a totally new particular standard related to the 3Ed EN 60601-1:2006 is work in progress. This question is relevant at least for:
– 60601-2-63: for dental extra-oral x-ray equipment,
– 60601-2-64: light ion accelerators,
– 60601-2-65: for dental intra-oral x-ray equipment,
– 60601-2-66: hearing aids and hearing systems

Officially such MEE’s shall fulfil the complete 3Ed EN 60601-1:2006 plus the relevant particular standard 60601-2-XY at the date 2012-06-01, unless there is a specific transition period for the applicable particular standard. Usually no specific transition period for the totally new particular standards are defined in the OJ, therefore, 2012-06-01 will apply.

Is there any guidance beyond the general advice to discuss specific problems related to the application of these new standards with the NB and using Risk Management?

Can 3 years transition period for the EN 60601-2-XY be claimed starting from publishing the EN version of the particular standard?

Q3. Is ZLG paper 3.5 A1 legally binding for EU NB’s and MEE manufacturers:
The ZLG-paper 3.5 A1 addresses a valid concern extremely clear: “The missing new assessment by the manufacturer after the end of the “doc” or the missing knowledge about the existing of new harmonized standards or scientific knowhow are substantial NON-conformities. If these NON-conformities will not be adequate corrected, the certificates have to be suspended or withdrawn.”
Is this paper legally binding? Am I allowed to ignore it? In clear words: If the “doc” is over and I have not objective evidence about the new 3Ed EN 60601-1:2006 requirements in a point-by-point protocol format, is my NB forced to suspend or withdraw my CE-certificate?

[1] Collateral standards under the MDD & AIMD: CLC/TC 62 questions and answers on the EN 60601-series of standards in relation to the MDD and AIMD