Article 10, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Information on Incidents Occurring Following Placing of Devices on the Market.” In short, this Article establishes the reporting requirements for incidents within the European Union, also known as vigilance reports. When a Member State becomes aware of a problem device, which has led to death or serious injury, or has the potential to lead to death or serious injury of the patient or user, the event shall be documented and the appropriate investigation pursued.
The approach to the reporting of device-related incidents, within the EU, has improved dramatically over the past three years, with the data now being shared with the Competent Authorities in all Member States. If a device manufacturer is placing product into the EU that is hurting or capable of hurting the patient or user they must react quickly in identifying suspect lots, notifying the users, withdrawing the product (RECALL), and completing the failure investigation. Failure to do so may result in the device manufacturer never recovering from the dégringolade (look-it-up) that will ensue from not taking prompt action.
The MDD – 93/42/EEC
Article 10 – Information on Incidents Occurring Following Placing of Devices on the Market
Member States shall take the necessary steps to ensure that any information brought to their knowledge, in accordance with the provisions of this Directive, regarding the incidents mentioned below involving a Class I, IIa, IIb or III device is recorded and evaluated centrally:
(a) Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(b) Any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in subparagraph (a) leading to systematic recall of devices of the same type by the manufacturer.
2. Where a Member State requires medical practitioners or the medical institutions to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorized representative, is also informed of the incident.
3. After carrying out an assessment, if possible together with the manufacturer or his authorized representative, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimize the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.
4. Any appropriate measures to adopt procedures to implement this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).
What you need to know
As a device manufacturer, you need to know that all reportable incidents in the EU require immediate action. This includes not only the potential market withdraw (RECALL) but the effective failure investigation into the cause of the device leading to patient or user injury or death. This includes the potential for injury or death. The focus of the subsequent investigation needs to be root cause with an outcome that supports the prevention of any recurrence of device failure in the future. It is also important to remember, Article 10 is also applicable to the labeling and Instructions for Use (IFU). If the device labeling and/or IFU was the cause of the injury or death to the patient or user, they need to be revised.
Remember, a good failure investigation is all encompassing. At the end of the day, devices should not be hurting the patient or user. When injuries or death occurs, the Competent Authorities will expect the devices to be withdrawn. Can you say that nasty six-letter word, RECALL?
What you need to do
It has always been the humble opinion of Dr. D, prevention of devices problems is always the best policy. How do device manufacturers implement a good prevention program? It starts with a good design, continues with a robust approach to design and process validation, is supported by manufacturing in an environment where the operators and inspectors are adequately trained, ensures that the users are properly trained in the application of a finished medical device, and maintains an effective post-market surveillance program to address device issues when incidents involving patient or user injury or death, are reported.
Similar to FDA’s approach to MDRs and MAUDE, device manufacturers must be proactive when issues occur with their devices within the EU. Yes, Dr. D understands that there is no such thing as a medical device utopia; and devices will occasionally fail. However, depending on how device manufacturers respond will determine if they will be allowed to continue to play in the EU’s medical device sandbox. One final point, the doctor mentioned in a DG Article, a few weeks ago, the EU does have a reporting requirement for devices that cause patient injury or death. MEDDEV 2.12 rev 5 (Guidelines on a Medical Devices Vigilance System). Additionally, the EU now has a database for capturing Vigilance Reporting Data (Medical Devices Sector – Implementation Vigilance Competent Authorities Notification Reports).
The key takeaway from this edition of DG is that there is an incident reporting system alive and well within the EU. Device manufacturers are expected to act immediately when reports of patient and user injury or death occur. This action needs to include a root-cause failure investigation and the implementation of appropriate remediation steps to prevent a recurrence of device issues in the EU. Trust Dr. D when I say, the Competent Authorities have the ability to make your and your Notified Body’s lives extremely miserable, if your devices are causing harm or can potentially cause harm in Europe.
Until the next installment of DG, when Dr. D will provide guidance for complying with Article 11 (Conformity Assessment Procedures) 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.
- MEDEV 2.12-1 rev 5. (2007, April). Guidelines on a medical devices vigilance system. European Commission DG Enterprise and Industry. Retrieved February 26, 2011, from www.gtlaw.com/portalresource/lookup/wosid/contentpilot
- Vigilance Reports. (2011, February). Europa.en Website. Retrieved February 26, 2011, from http://ec.europa.eu/consumers/sectors/medical-devices/documents/vigilance-reports/index_en.htm