European Union postpones new requirements for medical devices

On Friday, April 17, 2020 The European Parliament has adopted the Commission proposal to postpone the implementation of new approval rules for medical devices,

 

New regulations for medical devices, expected to be fully applicable on May 26, 2020, proposed to be postponed for 1 year (new effective date May 26, 2021).

 

In a press release by the European Parliament they note;

 

“The European Parliament is therefore supporting the proposal to postpone the application of this Regulation by one year to allow authorities and manufacturers alike to prioritise the fight against the coronavirus pandemic by continuing under current procedures.”

 

The European Member States will need to approve the proposal and publish in the Official Journal of the European Union. Expectations are this will happen prior to May 26, 2020.

 

The In Vitro Diagnostics Medical Devices Regulation is not affected by the new proposal, and its applicability date remains, effective May 26, 2022.

 

Ref:

 

EU Parliament press release

 

New regulations on medical devices

Q&A; applicability of EMC directive to SIM (subscriber identity module)

Question:

Application of the EMC Directive to SIM.

“Does the EMC Directive apply to smart cards, SIM cards and other contact cards? If so, what do you think are the applicable standards?”

Answer:

My understanding is that the common SIM requires an external power source and data interface to function, so assuming the SIM card performs no independent intrinsic function, and thus is not considered an "apparatus", but rather a "component" or "Sub-assembly" and must be paired with a device designed to operate with it, the EMC directive is not independently directly applicable to the SIM.

However, the SIM will be subjected to the same environment the intended host is subjected to, so it should be capable of compliance under such conditions, and with whatever directive(s) the host, or hosts, are governed by, and should not compromise the compliance of any given host. However, testing in one configuration considered "Typical" does not automatically guarantee compliance in all use cases.

Testing to a given set of harmonized standards is one of the tools used to assess compliance with the essential requirements of a given directive, but is not a requirement in and of itself, nor does it guarantee compliance with the essential requirements.

The broader the use case, the broader the assessment needs to be. Consider mobile phones, medical devices, information technology equipment, etc...

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Note the “Answer” to the question presented is only opinion, but based on extensive knowledge of the applicable EMC requirements. The responsibility for compliance with any requirement rests with the given product manufacturer.

European Harmonized standards list update

The list of harmonized standards for the following directives have been updated.

updated 8/19/11. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Other language copies can be found here

Updated 8/31/11Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to Electrical Equipment designed for use within certain voltage limits. Other language copies can be found here

As always copies of the newest lists for EMC, R&TTE, LVD and Medical Devices can also be found at http://celectronics.com/europe.htm

By: J Klinger

Do you mind turning off your RF device please?

Image by James Provost via Flickr

According to a Parliamentary Assembly of the Council of Europe (PACE) report issued May 6, 2011, “waiting for high level scientific and clinical proof that electromagnetic fields emanating from high frequency sources such as radar, telecommunications and mobile phones may lead to very high health and economic costs”.
PACE will be meeting in Kyiv on May 27th, and hold a debate, and intends to adopt a resolution on the issues raised in the report.
The report invokes heath concerns, in particular using examples of asbestos, lead, and tobacco, as mistakes made in the past when dealing with unknown health risks. The report also likens the potential consequences on the environment by electromagnetic fields with licensing of medication, chemicals, pesticides, heavy metals and genetically modified organisms.
The report recommends that an “as low as reasonably achievable” approach be adopted when setting standards or threshold values for emissions of electromagnetic fields of all types and frequencies. The report urges that particular attention should be given to protecting children, and “electrosensitive” persons suffering from a syndrome of intolerance to EM fields with a call to protect them from the unknown effects of electromagnetic waves by the creation of “Wave-free” areas not covered by wireless networks.
Mobile phones, DECT phones, WiFi, WLAN and WIMAX come under focus in the reports, with the call for microwave long-term exposure thresholds of not to exceed 0.6 v/m and in the medium term reduced to 0.2 v/m. The report also makes recommendations to; undertake risk-assessments prior to licensing new types of devices, calls for additional labeling and indications of health risks, produce warnings and recommendations to use a wired alternative due to the “unknown” dangers of electromagnetic fields..
The report proposes the ban of all mobile phones and wireless networking devices from schools and classrooms.

By: J Klinger

EMC List of Harmonized standards published

Image by CmdrFire via Flickr

An updated list of harmonized standards under 2004/108/EC, the EMC directive, has been published in the Official Journal of The European Union.

Find a copy of this list, along with updated lists for the R&TTE Directive 1999/5/EC, Low Voltage Directive 2006/95/EC, Medical Device Directive 93/42/EEC, and ERC Recommendation 70-03 relating to the use of Short Range Devices, at http://www.celectronics.com/europe.htm

EN 60601-1-2:2007, Version required, or not?

EN 60601-1-2:2007 is the Medical electrical equipment collateral standard for Electromagnetic Compatibility requirements and tests, harmonized under directive 93/42/EEC (medical devices).

While this standard has a date of publication of February 1, 2008, it as no fixed date of withdrawal replacing EN 60601-1-2:2001 +A1:2006. Therefore, A1:2006 remains valid until all related part 2-X standards have been withdrawn.

However, when Part 1-2 is used, not in conjunction with a related part 2-x standard, EN 60601-1-2:2001 +A1:2006 has an effective Date of withdrawal (DoW) of September 12th, 2009.

That is to say, compliance must be demonstrated against the 2007 version after 9/12/2009 for appliances not covered under a particular Part 2 standard.