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RoHS in connection with MDD, AIMDD and IVDD

Status as of October 30, 2013

Which products fall under the RoHS directive 2011/65/EU?

Is MDSS automatically Authorized Representative for the RoHS directive when already appointed Authorized Representative for the MDD or IVDD?

Must manufacturers who do not have their registered place of business in the EU designate an Authorized Representative for the RoHS?

Must documents demonstrating compliance with the RoHS within the EU be kept available?

Should MDSS – if already designated as Authorized Representative for a medical device – be also appointed Authorized Representative for the RoHS for this device?

Which products fall under the RoHS directive 2011/65/EU?

Answer:

The RoHS directive applies to (RoHS RL 2011/65/EU Article 4 Paragraph 3):

  • All medical devices placed on the market from July 22, 2014 and falling under the definition of Electrical and Electronic Equipment
  • All IVD products placed on the market from July 22, 2016 and falling under the definition of Electrical and Electronic Equipment

As of today, active implantable medical devices are still excluded from this directive. In case of larger electrical medical devices such as an MRI scanner, it has to be clarified upfront whether this device falls under the term “large-scale fixed installation”, as then the RoHS directive would no longer be applicable.

RoHS RL 2011/65/EU (Article 3 Paragraph 1):

  • ‘electrical and electronic equipment’ or ‘EEE’ means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1 000 volts for alternating current and 1 500 volts for direct current;

Is MDSS automatically Authorized Representative for the RoHS directive when already appointed Authorized Representative for the MDD or IVDD?

Answer:

No, it is not. Under the definition of “Authorized Representative”, both directives (MDD and IVDD) point out that appointing an Authorized Representative applies only for the respective directive.

MDD 93/42/EEC (Article 1 Paragraph 2 j):

  • ‘authorised representative’means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive.

Only the manufacturer ensures by affixing the CE mark that the products meet the requirements of the MDD as well as the RoHS or other directives.

MDD 93/42/EEC (Article 4 Paragraph 5):

  • Where the devices are subject to other Directives concerning other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that the devices also fulfill the provisions of the other Directives.

Must manufacturers who do not have their registered place of business in the EU designate an Authorized Representative for the RoHS?

Answer:

No, this is not explicitly required in the Directive 2011/65/EU. The directive leaves the choice of whether or not to appoint an Authorized Representative to the manufacturers.

RoHS RL 2011/65/EU (Article 8 (a):

  • Manufacturers have the possibility to appoint an authorized representative by written mandate. The obligations laid down in point (a) of Article 7* and the drawing up of technical documentation shall not form part of the authorised representative’s mandate.

*When placing EEE on the market, manufacturers ensure that it has been designed and manufactured in accordance with the requirements set out in Article 4.

If an Authorized Representative is appointed, there is no labeling obligation to disclose the AR on the packaging or the accompanying documentation as it is required e.g. by the MDD. It is only required that the importer indicates his name or registered trade name and the contact address in addition to the one of the manufacturer either on the product itself or on the packaging or the accompanying documentation.

RoHS RL 2011/65/EU (Article 9 d):

  • Importers indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the EEE or, where that is not possible, on its packaging or in a document accompanying the EEE.

Must documents demonstrating compliance with the RoHS within the EU be kept available?

Answer:

The directive 2011/65/EU does not make a clear statement on this. The importer is obliged to keep a copy of the Declaration of Conformity for a period of 10 years for market surveillance authorities and must ensure that the technical documentation can also be made available. The last section suggests that the Commission leaves open for both parties, where the information are deposited. The importer must only ensure that these can be presented on request.

RoHS RL 2011/65/EU (Article 9 g):

  • Importers keep, for 10 years following the placing on the market of the EEE, a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

If the manufacturer designates an Authorized Representative, the Authorized Representative must keep the EU Declaration of Conformity and the technical documentation.

RoHS RL 2011/65/EU (Article 8 b):

  • An authorised representative performs the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:
    • keep the EU declaration of conformity and the technical documentation at the disposal of national surveillance authorities for 10 years following the placing on the market of the EEE.

Should MDSS – if already designated as Authorized Representative for a medical device – be also appointed Authorized Representative for the RoHS for this device?

Answer:

If a manufacturer does not wish to do so, he must declare that he has not, and will not, appoint another one. The MDD requires in Article 14 Paragraph 2 that only one Authorized Representative for the EU may be appointed for a medical device.

MDD RL 93/42/EEC (Article 14 Paragraph 2):

  • Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union.

Even if this is not directly mentioned, we can assume that this means “a single Authorized Representative per product or product group”.

RL 2007/47/EC (Statement 14):

  • To ensure that, where a manufacturer does not have a registered place of business in the Community, authorities have a single individual person authorised by the manufacturer whom they can address in matters relating to the compliance of the devices with the Directives it is necessary to introduce an obligation for such manufacturers to designate an authorised representative for a device. This designation should be effective at least for all devices of the same model.

The IVD directive leaves this issue open; it only states that an Authorized Representative must be appointed.

IVDD RL 98/79/EC (Article 10 Paragraph 3):

  • Where a manufacturer who places devices on the market under his own name does not have a registered place of business in a Member State, he shall designate an authorised representative.

This, however, may be specified by the national transposition, for example in Germany, the MPG; §6 Section 2 states: “(…) If the manufacturer does not have his registered place of business within the European Economic Area, the medical device may only be CE marked if the manufacturer has appointed a single Authorized Representative responsible for the medical device in the European Economic Area.”

When appointing MDSS as Authorized Representative for the RoHS directive, at least the following must be ensured: RoHS RL 2011/65/EU (Article 8b):

An authorised representative performs the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

  • Keep the EU declaration of conformity and the technical documentation at the disposal of national surveillance authorities for 10 years following the placing on the market of the EEE,
  • further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of an EEE with this Directive,
  • cooperate with the competent national authorities, at their request, on any action taken to ensure compliance with this Directive of EEE covered by their mandate.