CE-marking on medical devices

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CE-marking on medical devices

Implants are medical devices. Testing is required prior to implementation or application, as expressed by the CE-marking on the device, which ultimately safeguards the international market suitability and promotes consumer protection.

The following decision by the local court of Frankfurt a.M. (31 C 635/11 844) dated 05.06.2011 examines the question whether the absence of a CE-marking on a medical device constitutes a material or a legal defect.

Under a purchase contract dated 30.06.2010 the defendant bought a dental treatment unit from the claimant for an tax-inclusive price of EUR 20,100. Installation. It was a unit made by the Ukraine-based manufacturer Galit, Model Gallant autark, with diverse accessories. The authorised representative of the manufacturer in the European Economic Area is the company KOMA s.r.o. based in the Czech Republic.

The defendant paid a first instalment of EUR 12,100. The remaining EUR 8,000 were to be paid in 16 instalments of EUR 500 at the end of each month, starting at the end of the month during which the unit was installed. According to the claimant's General Terms and Conditions a transaction fee of EUR 10.00 was to be applied to each instalment, which was to be collected with each debit transaction. 

Installation took place in August 2010. With the action, the claimant seeks to recover the outstanding instalments for the months August, September, October and November 2010.

In a telefax dated 30.09.2010 the defendant gave notice that the unit was defective. The claimant engaged an external technician who checked the unit on its behalf on 05.10.2010 without finding any defects. The claimant informed the defendant accordingly in a letter dated 11.10.2010 (p. 7 of the file), which is cited here because of the different tests that were carried out. During the legal dispute the defects associated with the unit are no longer alleged.

According to an invoice dated 18.10.2010, the technician charged the claimant EUR 661.31 for the call-out on 05.10.2010. The claimant paid this invoice. In the action, the claimant seeks reimbursement of this amount from the defendant.

In a letter dated 18.10.2010, the claimant sent a declaration of conformity, the EU-certificate of conformity of the company EUROCAT and the certificate of EUROCAT to the defendant (cf. p. 39-42 of the file). At the same time the claimant demanded payment for the technician's invoice within seven working days.

The claimant demanded payment several times, most recently in a letter dated 06.12.2010.

Subsequently, the claimant instructed its current legal representatives. They first checked whether the contract could be be unravelled. However, the claimant initially decided to claim the outstanding instalments as well as the expenses for the technician. The legal representatives once again demanded payment from the defendant in a letter dated 09.12.2010, cf. p. 8 of the file.

In a writ dated 15.04.2011, the defendant claimed a right of retention, as a complete invoice with statement of value added tax (VAT) had not been received, which is not contested between the parties.

Enclosed with the writ of the claimant dated 21.04.2010 were the German instruction manual as well as once again the Certificates ZQ081917-13, ZQ100702-V, CQ110281-II, CQ110281-13 besides other enclosures, cf. enclosures K10.16, p. 96-16, including carbon copies for the defendant.

In sending the certificates with the letter dated 18.10.2010, the claimant believed to have demonstrated that all legal requirements for the import and use of the units in Germany have been met. In this respect reference was made to the photocopies of the corresponding certificates, p. 39-42 of the file. A clearly visible type plate with dimensions of approx. 5 x 10 cm could furthermore be found at the base of the foot of the chair of the unit, which provided all officially required device details (CA, ISO, test numbers, device number etc.).

The claimant alleges that CE marks are also present on all manuals and technical descriptions that were given to the defendant at the time installation.

In a decision dated 03.03.2011, the local court in Lüneburg referred the legal dispute to the local court of Frankfurt am Main.

The claimant requests

that judgement is passed to order the defendant to pay the claimant EUR 2,703.31 plus interest at 8 percentage points above the base rate of the ECB on EUR 510.00 respectively from 01.09.2010, from 01.10.2010, from 01.11.2010, from 01.12.2010 and from 01.01.2011 as well as on EUR 663.31 from 25.10.2010 as well as pre-litigation legal costs amounting to EUR 439.90.

The defendant requests

that the action should be dismissed.

The defendant asserts that the proper CE mark is missing on the treatment unit and on the associated instruction manual. In particular, the mark was missing completely on the main device with turbine, the treatment chair with lamp bore a CE mark, but one in which the final numbers (in this case 0535 for Eurocat) were missing. The extraction system bore the mark CA 0061, the compressor was lacking a CE mark, the manual which was incidentally was only drawn up in Cyrillic bore no mark at all.

The corresponding marking obligation follows from the medical device law that is applicable to the unit as well as from guideline 93/42/EWG of 14.06.1993.

The defendant believes that this must be regarded as a defect of the purchased article, giving them the right to refuse payment, as they would not be permitted to use the unit owing to the missing mark according to § 6 Para. 1 MPG and would be unable to sell the unit after ceasing to practice.

In a subsequently filed writ dated 07.06.2011, the defendant alleges that the water tank of the clean water system burst at night during the previous week, so that the claimant found a water puddle below the unit upon arrival in the morning.

Reasons for the decision:

The permissible claim is also well-founded for the most part, though the defendant is entitled to a right of retention, which meant that the defendant had to be ordered to perform concurrently.

I. To begin with, the claimant is entitled to a payment of EUR 2,040.00 based on § 433 Para. 1 BGB [German Civil Code] in connection with the purchase contract dated 30.06.2010.

The entitlement to the purchase price is unaffected by the missing CE mark on the dental treatment unit, which means that this question may be left open and no clarification by means of witness evidence is required.

Factually, the parties do not dispute that the treatment unit meets the technical requirements for bearing a CE mark. Claimants have in this respect produced all certificates.

The defendant only alleges that the mark itself is absent from the treatment unit. In contrast to the straight-forward case where an article that bears a mark or lacks a mark does not meet the requirements for issuance of the mark, this does not constitute, a material defect in the acquired treatment unit however.

The term material defect is defined in § 434 BGB. According to Sentence 1, the agreed quality of the article needs to be considered in the first step; a specific quality was not agreed in this case. According to Sentence 2, one then needs to examine the suitability for the use presupposed according to the contract, otherwise the suitability for ordinary use when the article is of a quality that is customary for articles of the same kind and that the buyer can expect for articles of this kind.

The ability by the defendant to use the acquired treatment unit as intended is not contested in the present case. The defendant uses the unit as intended in her consulting rooms, as apparent on the one hand from the correspondence subsequent to the technician visit on 05.10.2010, but also from the notice given in respect of the burst fresh water tank, which was first raised in the letter dated 07.06.2011. Apart from the point just mentioned, which will be discussed in more detail later, they claimed no material defects in the classical sense.

The treatment unit is generally designed in the customary manner and in the manner that a buyer can expect. To put it pointedly, the defendant merely complains about a missing sticker, though one that should be present according to the provisions of the MPG [Medical Device Law].

The evaluation of this constellation in terms of warranty law has not been object of case law as far as we can see, in contrast to the opposite case where a device bears a CE mark but does not meet the corresponding technical requirements. As far as we can see, only Niebling, in DB 1996, 80 ff., has examined this question and found in general that a qualitatively irreproachable article does not suffer from a material defect merely because the mark is missing. He also argues that an impaired ability to re-sell the article does not exist in law, as only the initial making available in the market and beginning to use are covered by criminal or monetary penalties. Only an economic disadvantage could arise from this, but this is likely to be irrelevant from the perspective of warranty law. The situation is only clear if an importer acquires articles that do not bear a mark outside the European Economic Area, as the importer is not authorised to place such articles on the market, but this only concerns the contractual relationship between manufacturer and importer, not between the importer and the ultimate customer. In this latter relationship, the negation of the relevance of the lack in terms of warranty law for material defects is upheld as a matter of principle.

Any damages that the defendant may have suffered owing to the missing mark in this constellation, would need to be captured via § 280 BGB. Corresponding damage claims, which may arise from §§ 42 Para. 1, 41 No. 2 MPG among others, have not been submitted.

The missing mark also does not constitute a legal defect according to § 435 BGB, as no third-party rights in the article of any kind can be discerned.

With respect to the burst fresh water tank, the claimant may be entitled to warranty or guarantee claims in the first instance. This does not affect that the purchase price has fallen due for payment. The defendant has not claimed a right of retention in this respect. For this reason, there was no need to re-open oral proceedings to provide an opportunity to the claimant to comment on this new submission.