On July 1, 2011, the Parliament and the Council of the European Union published Directive 2011/65/EU (ROHS 2.0) in the Official Journal of the European Union to replace Directive 2002/95/EC. The new Directive will enter into force in 20 days (i.e., July 21, 2011).
Application date:
Directive 2002/95/EC will be repealed as of January 3, 2013, and allied countries have until January 2, 2013 to update Directive 2011/65/EU to their local laws.
Products outside the scope of 2002/95/EC that are not subject to the updated Directive will continue to be placed on the market until July 22, 2019, which means that organizations can continue to distribute or use the products on the EU market for commercial purposes for a fee or free of charge.
The main contents of 2011/65/EU are summarized as follows:
1. Scope of products
The scope of control of the Directive and the relevant definitions are clarified, and the scope of controlled products is extended to all electrical and electronic equipment except for special exemptions:
-Including the exemptions of Class 8 products of medical equipment, Class 9 products of surveillance equipment and Class 9 products of medical equipment, Class 10 products of medical equipment, Class 11 products of surveillance equipment and Class 11 products of medical equipment. Medical equipment and surveillance equipment exempted by 2002/95/EC;
- Category 11 products: all other electrical and electronic equipment, including cables and other components, not covered by products in categories 1 to 10.
2. Restricted Substances
While no new restricted substances have been added, four toxic and hazardous substances (HBCDD, DEHP, DBP and BBP) have been selected as candidates for restriction.
HBCDD Hexabromocyclododecane
DEHP (2-ethylhexyl) phthalate
DBP Dibutyl phthalate
BBP Benzylbutyl phthalate
3. Requirements for CE marking
The compliance with ROHS for electrical and electronic equipment is included in the requirements for CE marking. Producers should ensure that their products comply with ROHS and prepare appropriate declarations and technical documentation when posting the CE marking.
4. Transitional Provisions
In order to enable the new inclusion of ROHS 2.0 control products manufacturers to have sufficient time to comply with the requirements of the directive, ROHS 2.0 for the relevant products to set up the control of the transitional period.
- Medical devices and monitoring equipment and their components shall comply with ROHS 2.0 from July 22, 2014;
- In vitro diagnostic medical devices and their components shall comply with ROHS 2.0 from July 22, 2016;
- Industrial surveillance devices and their components shall be compliant with ROHS2.0 from July 22, 2017;
- Other products newly included in the control of ROHS2.0 shall be compliant with ROHS2.0 from July 22, 2019;
5. Exemption Mechanism
Adoption Existing exemptions and proposed 20 new exemptions for medical and monitoring equipment, while the maximum validity period of exemptions for different product categories:
- The maximum validity period of the exemptions for the 8 categories of products and the 11th category of products originally controlled by 2002/95/EC is 5 years;
- The maximum validity period of the exemptions for the 8th and 9th categories of products is 5 years;
- The maximum validity period of the exemptions for the 8th and 9th categories of products is 5 years. The exemptions for category 8 and category 9 products are valid for a maximum of 7 years.
6. Addition of Market Surveillance Provisions
Introduction of harmonized product conformity assessment requirements and market surveillance mechanisms. This will reduce the number of non-compliant products in the market through strict and uniform market surveillance, thus effectively achieving the objectives of the Directive.
Related manufacturers should y understand the requirements of the Directive and take timely measures to ensure that their products comply with the new requirements of ROHS 2.0.
Medical Devices: ROHS 2.0 and Other Restricted Substances Requirements
● On July 1, 2011, ROHS 2.0 (2011/65/EU) was published in the Official Journal of the European Union (OJEU) and will come into force in 20 days.
● Compared to the original ROHS Directive 2002/95/EC, one of the major changes in ROHS 2.0 is that it includes all electrical and electronic products, including medical devices, in its scope of control.
● Considering the new requirements of ROHS 2.0 for medical devices, the world's leading medical device manufacturers, G and P, have started to investigate and control ROHS and other restricted substances.
The main elements of ROHS 2.0 are as follows:
- Clarification of the scope of the Directive and related definitions:
- Inclusion of medical and monitoring equipment in the scope of ROHS;
- Addition of an 11th category of products, i.e., other electrical and electronic products not covered by the previous 10 categories of products.
- Addition of an 11th category, i.e., other electrical and electronic equipment not covered by the previous 10 categories;
- Selection of four toxic and hazardous substances (HBCCD, DEHP, DBP, and BBP) as candidates for restriction, although no new restricted substances have been added.
- Incorporation of ROHS compliance for electrical and electronic equipment into CE marking requirements.
Medical devices controlled by ROHS 2.0 include:
- Devices that utilize electrical energy and meet the definition of a medical device in EU Directive 93/42/EEC;
- Devices that utilize electrical energy and meet the definition of an in vitro medical device in EU Directive 98/79/EC. .
In order to give manufacturers of products newly included in the control of ROHS 2.0 sufficient time to comply with the requirements of the Directive, ROHS 2.0 has set a control transition period for the relevant products, as shown in the following table:
Terms Scope of products Control transition period Remarks
Chapter 2, paragraph 2 Previously not subject to the control of 2002/95/EC, but not in compliance with ROHS 2.0 Products subject to the requirements of the Directive from July 22, 2019 Not to be incompatible with Chapter IV, paragraphs 3 and 4
Chapter IV, paragraph 3 Medical and surveillance equipment subject to the requirements of the Directive from July 22, 2014
In vitro diagnostic medical devices subject to the requirements of the Directive from July 22, 2016
Industrial surveillance equipment subject to the requirements of the Directive from July 22, 2017
Industrial surveillance equipment subject to the requirements of the Directive from July 22, 2016
Chapter 4, paragraph 4
Cables or components for repair, reuse, functional upgrading or expansion In electrical and electronic equipment placed on the market before July 1, 2006 No need to comply with ROHS 2.0
In medical devices Need to comply with the requirements of the Directive as of July 22, 2014
In vitro Diagnostic medical devices need to comply with the Directive from July 22, 2016
Surveillance devices need to comply with the Directive from July 22, 2014
Industrial surveillance devices need to comply with the Directive from July 22, 2017
Electrical and electronic equipment exempted and placed on the market before the expiry of the exemption do not need to comply with ROHS 2.0
Chapter 4, paragraph 5 Parts recovered from electrical and electronic equipment placed on the market before July 1, 2006 may be used in electrical and electronic equipment placed on the market before July 1, 2016 Reuse must be carried out in a monitored and closed B2B recycling system, and the consumer must be informed of this
And given the special requirements of medical and surveillance equipment in terms of reliability and safety, ROHS 2.0 is not applicable. Considering the special requirements for reliability and safety of medical and monitoring equipment, ROHS 2.0 provides a number of specific exemptions in addition to those for medical and monitoring equipment:
Equipment utilizing or detecting ionizing radiation:
1. Lead, cadmium, and mercury in detectors for ionizing radiation; Sensors, detectors, and electrodes:
1a. Lead and cadmium in ion-selective electrodes, including glass PH electrodes.
1b.Lead anodes in electrochemical oxygen sensors;
1c.Lead, cadmium, and mercury in infrared detectors;
1d.Mercury in reference electrodes: low-chloride mercuric chloride, mercuric sulphate, and mercuric oxide;
2.Lead bearings in X-ray tubes:
3.Electromagnetic radiation amplification equipment: lead in microchannel and capillary plates
4. Lead in glass melts in X-ray tubes and image intensifiers, vacuum tubes that convert electromagnetic radiation into electrons, and gas lasers.
5. Lead in shielding devices for ionizing radiation.
6. Lead in X-ray detection
7. Lead stearate X-ray diffraction crystals
8. Radioactive cadmium isotope sources in portable X-ray fluorescence spectrometers
Other
9. Cadmium in helium-cadmium lasers
10. Lead and cadmium in atomic absorption spectrometry lamps
11. MRI thermal Lead in conductors and superconducting alloys
12. Lead and cadmium in superconducting materials used in MRI and SQUID detectors
13. Counterweight lead
14. Lead in single crystal piezoelectric materials for ultrasonic transducers.
15. Lead in solder used to bond ultrasonic transducers
16. Mercury in bridges for high-precision capacitance and loss measurements, and in high-frequency RF switches or relays used in monitoring equipment at a level of up to 20 mg of mercury (per switch or relay)
17. Lead in solder in portable emergency pacemakers
18. Detection Range Lead in solder for high-performance infrared imaging modules with a detection range of 8-14 microns
19. Lead in silicon-based liquid crystal displays
20. Cadmium in X-ray measurement filters
Medical devices exported to the European Union (EU) are required to meet the new requirements set out in the new ROHS Directive 2011/65/EU, as well as other EU regulatory requirements:
The European Union REACH Regulation (EC) NO.1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). It aims to strengthen the management of the production and use of chemicals in the European Union, and almost all products placed on the EU market are affected by the REACH regulation. Medical devices, as "articles", are subject to a focus on the presence of Substances of Very High Concern (SVHC) in products. If a product contains SVHC candidate substances, depending on the concentration and total amount, the manufacturer or importer of the product should fulfill the corresponding notification or notification obligations. In addition to the medical device product itself, its packaging materials are considered to be separate articles and should also fulfill the requirements for articles under the RACH regulation.
In addition, the EU Directive 94/62/EC issued in 1994 requires that the sum of the content of the four hazardous heavy metals (lead, mercury, cadmium, hexavalent chromium) in packaging materials shall not exceed 100mg/kg: and the recycling rate of the packaging materials put forward hard indicators, such as the overall recycling rate shall not be less than 60%, the overall minimum recycling rate of 55%, as well as all types of packaging materials, the minimum recycling rate; at the same time, the packaging materials should also be marked with the required recycling symbols,
And in order to prevent the waste of electrical and electronic equipment caused by environmental pollution and waste of resources, the European Union on February 13, 2003, the introduction of the 2002/96/EC Directive (i.e., the "Directive on Off-gas Electrical and Electronic Equipment"), including medical equipment, including the 10 categories of electrical and electronic equipment, from the design of the product to the disposal of the The whole process is regulated, including the registration system before placing on the market, the 3R requirements (i.e., Recovery/Recycling/Reuse), the use of recycling symbols, and easy disassembly provisions.