Subsequent conformity assessment

Author: CEmarking TEAM | Last edited: 25.05.2020

There are still machines in operation which were "placed on the market" or "put into service" as self-produced after 31.12.1994 without meeting the formal requirements of the Machinery Directive 2006/42/EC. This means that there is no EC Declaration of Conformity for these machines and they do not bear the CE marking.

How do the authorities and insurers react, and are such machines / plants shut down if necessary?

In order to answer this question, it is necessary to first take a look at the provisions governing the placing on the market and commissioning of machinery and equipment. A further topic is then the responsibility in the event of a delayed conformity assessment. The question of whether a delayed (subsequent) conformity assessment is legally permissible at all should also be examined, if only because there are those who doubt this. The possible measures of market surveillance will also be considered.

placing on the market & commissioning of machines

The first use is determined by the date on which the machinery is regularly placed on the market or, in the case of self-produced machinery, the date on which it is first used or put into service. See Machinery Directive 2006/42/EC

'placing on the market' means making a machine or partly completed machinery available for the first time in the Community with a view to distribution or use, whether for reward or free of charge
'commissioning` means the first use of machinery covered by this Directive for its intended purpose in the Community

Responsibilities for conformity assessment

In principle, the manufacturer is responsible for carrying out the conformity assessment, CE marking and issuing the EC conformity assessment. This must be completed when the device is placed on the market or, in the context of in-house production, when it is commissioned. In the context of a "delayed" conformity assessment, which becomes necessary if the manufacturer has not fulfilled his obligations under public law at the required time, the following are:

  1. The manufacturer shall subsequently carry out the " missed " conformity assessment procedure, draw up an EC declaration of conformity and affix the CE marking.
  2. In the case of in-house production, the persons acting at the time are often no longer available, but the company is still formally " tangible " as an in-house manufacturer. In this case, it may still be possible to refer to the documents for the machine or plant created in the company at that time.
  3. In the case of purchased machines / systems that have been accepted without "CE" and are already in use, it is often no longer possible to fall back on the actual manufacturer. The operator will then have no choice but to carry out the conformity assessment of the machine / plant himself, so that it can be made available to the employees in a legally compliant manner. If necessary, he can obtain assistance from the original manufacturer or also from a service provider.
  4. The operator carries out a conformity assessment based on the current state of the art and notionally puts them on the market again.

In cases 2 and 3 there is no reason in principle why the operator or a person appointed by him should not establish the lack of conformity and carry out a conformity assessment himself. As a conclusion of the subsequent conformity assessment, he could in these cases issue an "EC Declaration of Conformity" at the time of completion of the subsequent conformity assessment, in order to make it clear that this is a subsequent EC Declaration of Conformity and who, if applicable, is the original manufacturer of the machine. Even if such a declaration does not formally exist, he may be able to reduce his responsibilities in the future. For this purpose he can affix the CE marking and the year of manufacture.

Subsequent conformity assessment prohibited?

It cannot be inferred from the obligation that the manufacturer must implement the above-mentioned requirements before placing on the market and/or putting into service that the manufacturer may not or cannot make up for these requirements after placing on the market and/or putting into service if he has "forgotten" to do so at the time actually required.

In this respect, the market surveillance authority may require the manufacturer to bring the product into conformity even after it has been placed on the market and/or put into service and may also sanction the failure to do so as an administrative offence.

Failure to submit the technical file to the competent authorities may constitute sufficient grounds for the authority to doubt the conformity of the machinery with the essential health and safety requirements set out in Annex I.

Year of construction may not be dated after?

As a further objection, it is sometimes mentioned in Annex I, No. 1.7.3 of the Machinery Directive that the year of construction of a machine may not be dated before or may be dated after. Annex I, No. 1.7.3 specifies this specifically:

"It is prohibited to date the year of construction of the machinery before or after affixing the CE marking.

Retrofitting on the basis of occupational safety

However, in the context of the ex-post conformity assessment, the operator should also determine whether there are any obligations arising from the OSHA which result in the need to retrofit the machinery compared to the date of first placing on the market.

The risk assessment shall be reviewed regularly. The state of the art must be taken into account. If necessary, the protective measures for the use of work equipment must be adapted accordingly.

Insurance benefits in the event of damage

In the event of damage to machinery and equipment, it is not only the authorities who intervene. Insurance companies also come into play here, because the damage incurred must be settled. However, the insurance companies do not always pay or settle first and obtain recourse claims from the originator.

In the event of damage, the statutory accident insurers must hold the person responsible for the damage liable if he or she acted intentionally or with gross negligence. In doing so, they demand that the person causing the damage reimburse all their expenses for the settlement of the claim. In this respect, in the case of a machine without "CE", it would have to be questioned in each individual case whether this is due to intent or gross negligence on the part of the parties involved. Today, it can certainly be assumed that the manufacturer and employer have sufficient knowledge that the product legal regulations must be observed.