Article 10 (Registration of Manufacturers and Devices) of the IVDD (98/79/EC) delineates the notification requirements in regards to the Competent Authorities located in each of the Member States; and the need to have a European Authorized Representative, with a valid European address, if a manufacturer does not have a registered place of business within the friendly confines of the European Union. Additionally, Article 10 requires IVDD manufacturers to: (a) provide the address of the manufacturer’s registered place of business; (b) provide specific product information; (c) provide analytical and diagnostic parameters for devices employed for self-testing; (d) provide notification for when significant design changes occur; (e) provide certificates; and (f) provide notification when a device can be categorized as new.
On the flip side, Member States must ensure this data is loaded into the European Databank (Article 12). Finally, it is incumbent upon the manufacturer to ensure each Member State, receives the proper notifications in regards to placing products onto the European Market; but hey, no worries here as device manufacturers pay their notified bodies to perform these types of activities. Remember, it is never a wise policy to employ stratagems (look-it-up) when working to introduce IVDDs into commerce within the European Union (EU). This approach will surely anger the regulatory gods. Besides, device manufacturers pay their notified bodies a handsome sum of money, so do not be afraid to use them.
The IVDD – 98/79/EC
Article 10 – Registration of Manufacturers and Devices
1. Any manufacturer who places devices on the market under his own name shall notify 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,
- of information relating to the reagents, reagent products and calibration and control materials in terms of common technological characteristics and/or analytes and of any significant change thereto including discontinuation of placing on the market; for other devices, the appropriate indications,
- in the case of devices covered by Annex II and of devices for self-testing, of all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Annex I, part A, section 3, the outcome of performance evaluation pursuant to Annex VIII, certificates and any significant change thereto, including discontinuation of placing on the market.
2. For devices covered by Annex II and for devices for self-testing, Member States may request to be informed of the data allowing identification together with the label and the instructions for use when such devices are placed on the market and/or put into service within their territory. These measures cannot constitute a precondition for the placing on the market and/or putting into service of devices which are in conformity with this Directive.
3. Where a manufacturer who places devices on the market under his own name does not have a registered place of business in a Member State, he shall designate an authorized representative. The authorized representative shall notify the competent authorities of the Member State in which he has his registered place of business of all particulars as referred to in paragraph 1.4. The notification referred to in paragraph 1 shall also include any new device. In addition, where, in the context of such notification, a device notified, bearing the CE marking, is a ‘new product`, the manufacturer shall indicate this fact on his notification. For the purposes of this Article, a device is ‘new` if:
- there has been no such device continuously available on the Community market during the previous three years for the relevant analyte or other parameter;
- the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Community market during the previous three years.
5. Member States shall take all necessary measures to ensure that the notifications referred to in paragraphs 1 and 3 are registered immediately in the databank described in Article 12. The procedures for implementing this Article and in particular those referring to the notification and the concept of significant change shall be adopted in accordance with the procedure referred to in Article 7.6. Transitionally, pending the establishment of a European databank accessible to the competent authorities of the Member States and containing the data relating to all devices available on the territory of the Community, the manufacturer shall give such notification to the competent authorities of each Member State concerned by the placing on the market.
What IVD medical device manufacturers need to know
Article 10 is pretty straight forward in regards to specifying the basic requirements needed to comply with the manufacturer’s registration process. Similar to the MDD, device manufacturers that do not have a physical presence within the boundaries of the EU, must select and contract with a European Authorized Representative. Remember the contract piece as the notified bodies will ask to review it during their annual visits to your facility. Additionally there are several salient requirements identified within Article 10 that are not optional. The bottom line here is eloquently simple. Failure to comply with these salient requirements equates to no revenue stream coming from the sale of IVDDs, barred from entry into the EU. Why you ask? Because these devices will be “CE Markless” due to the manufacturer’s failure to comply. “CE Markless,” I like it, the doctor is now making up new words.
Regardless of where the EU authorized rep is located, IVDD manufacturers must provide the Competent Authorities with following pieces of information:
- Actual address where the IVDDs are manufactured;
- Specific product information on the reagents and reagent products, including calibration;
- Data /testing to support the introduction of products categorized as self-testing;
- Notification when products are discontinued;
- Product certificates;
- Significant changes made to products;
- When requested for self-testing devices, instructions for use; and
- A clear indication when products are newly introduced into the EU.
The good news is, as the doctor stated earlier, the notified bodies you pay and retain, will work to ensure the Competent Authorities receive all of the appropriate information delineated within Article 10. The key to success here is to ensure products targeted for entry into the European market comply with essential requirements and are safe and effective for their intended use, as supported by objective testing. I know Dr. D continually sounds like a broken record; however, without that prized CE mark, IVDDs cannot enter into the EU. Without technical documentation (technical files and design dossiers) to support evidence of complying with essential requirements, there is no chance of a device application ever being approved. That my friends, you can take to the bank; and the doctor is not talking about the European Databank.
Speaking of banks, there is a receptacle called the European Databank for Medical Devices (Eudamed) that is used by each of the Member States. For those of you not familiar with European Databank, Eudamed was created under the direction of 2010/227/EU, Article 1. The purpose of Eudamed is to enhance the market surveillance process by ensuring the Competent Authorities have access to information on devices, manufacturers, authorized reps, certificates, clinical data, vigilance reports, etc. Having this information available, real-time, improves the overall effectiveness of the Competent Authorities and their ability to protect the health of the general public for each of the Member States they serve. One final point in regards to Eudamed, as of May 2011 entering data into Eudamed is no longer optional but obligatory. The good news is that the data entry requirement is a Competent Authority responsibility and not a device manufacturer. The bad news for device manufacturers is that the Europeans are getting much better at handling and sharing device-related information. In short, there is no place for bad devices or unsavory device manufacturers to hide.
What IVD medical device manufacturers need to do
From Dr. D’s perspective, if the IVDD manufacturer has partnered with a competent notified body, the path to market entry into the EU, although never a simple task, will be predictable. As the doctor stated earlier, it is all about establishing documented evidence to support compliance with essential requirements. Remember, as part of the application process, the notified bodies are required to review and assess the technical data provided in support of the application process. Long gone are the days of self-certification for low-risk devices. That being said, the doctor would like to share a little secret. Technical Files and Design Dossiers are living documents, so to speak. They need to be reviewed and updated continuously as standards change and additional testing is required to claim ongoing compliance to essential requirements. The same holds true for design changes, manufacturing line locations etc. In the United States, PMA supplements, annual reports, etc. are salient requirements where failure to comply results in the wrath of the FDA being unleashed. That being said, the Competent Authorities have the potential to unleash the same fiery wrath for compliance issues. With the Eudamed database now officially live, manufacturer and device information is readily available at the fingertips of each Member State. The message here is simple; “Just comply baby, comply” (thank you Al Davis – the late owner of the Oakland Raiders).
Takeaways
The only takeaway from this week’s guidance is premised on the amount of information available to the Member States and their Competent Authorities. In accordance with Article 10, the Competent Authorities require specific pieces of information from IVDD manufacturers. The Competent Authorities are now required to upload this information into European Databank, a.k.a., Eudamed. The availability of this data to all Member States, allows for the effective management and if necessary, policing of devices being placed onto the European market. In closing, with the help of Eudamed, the Competent Authorities are watching, so just comply baby, comply.
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Article 11 (Vigilance Procedure) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – cheers from Dr. D and best wishes for continued professional success.
References:
- Commission Decision 2010/227/EU. (2010, April). Commission decision of 19 April 2010 on the European Databank on Medical Devices (Eudamed). Retrieved December 9, 2011, from http://eur-lex.europa.eu.
- Council Directive 90/385/EEC. (1990, June). Council Directive 90/385/EEC on the approximation of the laws of Member States relating to active implantable medical devices. Retrieved November 15, 2011, from http://eur-lex.europa.eu
- 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.
- Devine, C. (2011). Devine Guidance series on complying with the MDD. Published in The Medical Device Summit.
- Directive 98/34/EC. (1998, June). Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 – laying down a procedure for the provision in the field of technical standards and regulations and of rules on information society services. Retrieved November 15, 2011, from http://eur-lex.europa.eu
- Directive 98/79/EC. (1998, October). Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices Retrieved September 12, 2011, from http://eur-lex.europa.eu.
Related Articles
-
The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…
-
The CDRH notes that the goal of the guidance is to put safe and effective advancements in the hands of healthcare providers and users more quickly to help increase the pace of medical device innovation in the U.S. and enable…
-
The new guidance is intended to establish confidence in automation used for production or quality assurance systems and describe various methods and testing activities that may be applied to establish computer software assurance and meet regulatory software validation requirements.
-
The updated guidance document clarifies what constitutes a statement of the basis for the deficiency and includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process.
