EU Directive – Eisner Safety Consultants

Standards Reconnaissance Service Coming Mid Oct ‘15 to Eisner Safety Consultants

leoeisner — Wed, 30 Sep 2015 06:29:01 +0000

Do you want to ensure standards compliance to meet quality & regulatory requirements?

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:

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.)
List of standards publishers and the associated country.
List of Medical Device Regulators and their websites (if available).
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).

RoHS 2 Directive (2011/65/EU) Changes to Annex IV (Med Dvcs & Control/Monitoring Instruments) Exemptions Listing

leoeisner — Wed, 05 Mar 2014 06:50:19 +0000

(Originally posted March 5, 2014 & updated March 6, 2014) The changes made to these 16 Delegated Directives to the RoHS 2 Directive (2011/65/EU) add more exemptions to Annex IV of the Directive. Annex IV is for the “Applications exempted from the restrictions in Article 4(a) specific to medical devices and monitoring and control instruments”. Most of these exemptions are for medical devices and some have an expiration date and others don’t have an expiration date, at this time.

COCIR (a European medical device trade organization) requested twelve RoHS2 exemptions between September 2011 and March 2012 for Annex IV and all of them were granted as they are all noted in the below listing of 16 exemptions that were granted. COCIR produced a really helpful resource guide on the RoHS 2 Directive and if you would like to see the original exemptions list that COCIR requested go to section 8 of the document.

The exemptions that were added without an exemption date could be changed in the future so you should keep an eye out for changes to the exemptions list in Annex IV of the RoHS 2 Directive. Also, the Directive could have changes elsewhere such as the list of materials that are banned, most definitely will expand over time, in Annex II, among other changes. The best place to check for these changes is at the Europa Website for the RoHS 2 Directive under the heading RoHS 2 and then go down one more heading to Secondary Legislation on RoHS 2 which then has a sub-heading of Exemptions which currently has 3 listing in this section. One for the Commission Delegated Directive 2012/50/EU (the 1^st added exemption), for the Commission Delegated Directive 2012/51/EU (the 2^nd added exemption), and lastly the 16 Commission Delegated Directives 2014/1/EU to 2014/16/EU which is what the rest of this post is all about. See the below for the 16 Delegated Directives and links to each one of them. A description of each exemption is noted in the below listings for your ease of use here.

Walter Jager, of ECD Compliance, provided some clarification about exemptions without an exemption date. He advised me the following:

“It’s also important to note that the RoHS 2 Annex IV exemptions that have no expiry date are valid for up to 7 years. For example, for most category 8 medical devices (ie. the medical devices that must be RoHS compliant by July 22, 2014) these Annex IV exemptions will automatically expire on 22 July 2021 . A manufacturer or industry association may apply to extend the exemption if there is still justification, but the application needs to be made at least 18 months before the expiry date. For category 8 in-vitro devices the default expiry is 22 July 2023 (22 July 2024 for category 9 industrial monitoring and control equipment). The recent Annex IV exemptions generally have fixed expiry dates.”

Commision Delegated Directive 2014/1/EU amending…Directive 2011/65/EU

an exemption for lead as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation

Commision Delegated Directive 2014/2/EU amending…Directive 2011/65/EU

an exemption for cadmium in phosphor coatings in image intensifiers for X-ray images until 31 December 2019 and in spare parts for X-ray systems placed on the EU market before 1 January 2020

Commision Delegated Directive 2014/3/EU amending…Directive 2011/65/EU

an exemption for lead acetate marker for use in stereotactic head frames for use with CT (Computed Tomography) and MRI and in positioning systems for gamma beam and particle therapy equipment

Commission Delegated Directive 2014/4/EU amending…Directive 2011/65/EU

an exemption for lead enabling vacuum tight connections between aluminium and steel in X-ray image intensifiers

Commission Delegated Directive 2014/5/EU amending…Directive 2011/65/EU

an exemption for lead in solders on printed circuit boards, termination coatings of electrical and electronic components and coatings of printed circuit boards, solders for connecting wires and cables, solders connecting transducers and sensors that are used durably at a temperature below – 20 °C under normal operating and storage conditions

Commission Delegated Directive 2014/6/EU amending…Directive 2011/65/EU

an exemption for lead in the surface coatings of pin connector systems requiring nonmagnetic connectors which are used durably at a temperature below – 20 °C under normal operating and storage conditions