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Article 14, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Registration of persons responsible for placing devices on the market.”
I wanted to start this week’s guidance with a quick story. I received an email from a dear friend of mine living in Ireland concerning my use of the MS Word™ spell-check feature. He asked me, “How come Dr. D was changing the spelling for some of the key terms, e.g., authorised versus authorized?” My answer was quite simple; “Some folks need to learn how to spell.” His response, “Well Chris, I can teach you if you give me a chance, and a few pints.” A few pints actually sounds like a good deal.
Moving on, as Dr. D continues to concatenate (look-it up if you must), articles on the MDD, the underlying theme of the series continues to be compliance, compliance, and more compliance. The doctor continues to receive a significant volume of email reminding me that distributing devices into the EU is viewed as somehow being different than entering product into commerce within the United States. My answer is; “no, not really.” Just as in the United States and the Quality System Regulation, the MDD is law for 27-Member States. Failure to comply with the Directive will result in product being blocked from entry into the EU. Can you say; “Please remove our CE Mark immediately?” Since the CE Mark belongs to your notified body, they retain the right to ask for its removal, if compliance issues arise.
The MDD – 93/42/EEC
Article 14 – Registration of persons responsible for placing devices on the market
Any manufacturer who, under his own name, places devices on the market in accordance with the procedures referred to in Article 11 (5) and (6) and any other natural or legal person engaged in the activities referred to in Article 12 shall inform the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business and the description of the devices concerned. For all medical devices of classes IIa, IIb and III, Member States may request to be informed of all data allowing for identification of such devices together with the label and the instructions for use when such devices are put into service within their territory.
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 authorized representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorized representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.
The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1given by the manufacturer or authorized representative.
What you need to know
As a device manufacturer, Article 14 is an extremely important one to understand. Under Article 14, device manufacturers are required to establish a European Authorized (sorry friend – spelled correctly in the U.S.) Representative. The good news is that device manufacturers are not required to have an EU Authorized Rep in each Member State. One will do just fine. Additionally, the EU Authorized Rep should have an accurate list containing the product names, UPNs, etc. of all of the devices entered into commerce within the EU.
Furthermore, device manufacturer’s need to have written contract/agreement with their EU Authorized Rep. Although not spelled out directly in Article 14, your notified body will ask to see a current contract/agreement during their annual visit to your facility. Finally, make sure that the address of the EU Authorized Rep makes its way onto the actual product labeling. It is Dr. D’s humble opinion; it is a salient requirement equal to that of the CE Mark being placed on the product labeling.
What you need to do
Number one, not wanting to state the obvious, but obliged to do so, device manufacturers need to establish a European Authorized Representative Office in a Member State. This is not an option.
Number two, device manufacturers need to ensure a written contract/agreement is in place with the EU Authorized Rep. This document should clearly delineated the responsibilities for each party within the body of the agreement.
Number three, ensure the EU Authorized Rep has an accurate list of devices being sold into the EU. Device manufacturers can perform a quick check for accuracy by comparing the product list residing with the EU Authorized Rep and the list(s) maintained by your notified body or bodies, if you have more than one.
Number four, ensure the EU Authorized Rep address makes its way onto the product labeling. It is a legal requirement for product entering into commerce within all 27-Member States.
The takeaway for this edition of DG is extremely simple and once again, the redundancy results in Dr. D entering the realm of broken-record time. However, understanding Article 14 is vitally important. Device manufacturers need to retain a European Authorized Representative in order to place medical devices into commerce in the EU. There needs to be: (a) a contract with the EU Authorized Rep; (b) an accurate product list on file with the EU Authorized Rep; and (c) the EU Authorized Rep address needs to be on the product labeling.
Until the next installment of DG, when Dr. D will provide guidance for complying with Article 14a (European Databank) of Council Directive 93/42/EEC, the MDD – cheers from Dr. D and best wishes for continued professional success.
- Council Directive 93/42/EEC. (1993, June). Council Directive 93/42/EEC concerning medical devices. Retrieved December 21, 2010, from http://eur-lex.europa.eu
- Devine. C. (2009, July). Exploring the effectiveness of defensive-receiving inspection for medical device manufacturers: a mixed method study. Published doctoral dissertation. Northcentral University. Prescott Valley, AZ.