The Medical Devices Expert Group, the Notified Bodies Group, the Notified Body Operations Group, the Medical Devices Competent Authorities Meetings, and working groups of the EU commissions apparently were not considered to be sufficient for a satisfactory consistency in the interpretation and implementation of medical devices regulation in the EU member states.
In September 2010, a new group was created, the Central Management Committee (CMC), whose mission is to develop the effectiveness of the regulatory system on medical devices in the EU by improving decision making among the national regulatory authorities.
A decision, taken by CMC, intended to achieve a common interpretation of the requirement that a manufacturer has in relation to the provision of its address on the label and the instructions for use (IFU) has been recently brought to the attention of the French medical device manufacturer association:
“The address of the manufacturer as required in the essential requirements on the labels and instructions for use, is the address of the registered place of business of the legally responsible manufacturer and shall include: street/road, number/house/floor, postal code, city, state/region, and country. The same details have to be provided for the address of the authorized representative.”
CMC’s reasons given for such a decision is that, “In practice, wide variations in the information provided have been noted. This could impact adversely on post market surveillance activities. In order to bring consistency and harmonization to this issue, the CMC decision was taken.”
Most EU national competent authorities are going to apply this decision in their territories. For example, in France, AFSSAPS will soon publish a notification to manufacturers which will request that their full addresses be printed on labels and IFU for devices put on the French market after September 1, 2012. That gives less than one year to comply.
MediMark Europe is very astonished by this decision. The harmonized standard, “EN 1041:2008 - Information Supplied by the Manufacturer of Medical Devices,” has been a presumption of conformity since August 31, 2011.
It is stated in the guidance for the essential requirements 13.3(a): “The full postal address may not be necessary if the information is sufficient to contact them, e.g., name or trade name, post code, country. However, the address needs to be sufficient to contact the physical location of the manufacturer and/or the authorized representative if applicable. The post box alone is not sufficient.”
The last sentence of this guidance means that a post office box alone without a postal code or city is not sufficient. But it does not mean that the full address is required on the label and IFU.
In addition, CMC’s decision states that, “The same details have to be provided for the address of the authorized representative.” This provision is contrary to article 13.3 of the medical device directive which states that the address of the authorized representative shall be on the label, or the outer packaging, or instructions for use, and not “on the label and on the instructions for use” such as requested in the decision.
One other question is the available size of the label for small medical devices such as orthodontic brackets. MediMark Europe believes that including the company name, post office box, postal code, city, state, and country are largely sufficient as a full address.
MediMark Europe hopes that the European and national manufacturer’s associations will fight this decision, which does not conform to the medical device and IVD directives and the EN 1041 harmonized standards.
Rene Clement is co-chairman of MediMark Europe, which serves as an authorized representative for U.S. manufacturers of medical devices and IVD products. For more information about the firm, visit the company's listing in the online Consultants Directory.