Article 16, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Notified Bodies.” For device manufacturers, the path to placing product into commerce within the European Union (EU) is through the notified bodies. In fact, the notified body, selected by a device manufacturer, will become a long-term partner, not unlike a marriage.
That being said, it is important that the notified body be an organization that you can be comfortable working with as a valued and trusted partner. One key concept to remember is that although the notified bodies are tasked with the review and approval of product applications for device manufacturers, including the design dossiers and technical files, they actual work for the manufacturer. The device manufacturer contracts with and pays the notified body for their services. Just wait until the device manufacturer receiving the invoices.
Another salient point to be made is that the notified body owns the CE Mark containing their registration number. For example, if a device manufacturer decided to choose TUV-R as their notified body, once product was approved for sale into the EU, the CE Mark containing the registration number 0197 would be affixed to all products entering into commerce within the EU. Simply put, no CE Mark equates to no European device sales. In fact, good luck with trying to ship product into one of the 27-Member States.
One final note, it is Dr. D’s personal opinion, a few notified bodies believe that they are holier than thou; however, device manufacturers should never feel obliged to pay obeisance (look-it up) to these regulatory bodies because at the end of the day, they are on your payroll, so choose wisely.
The MDD – 93/42/EEC
Article 16 – Notified Bodies
The Member States shall notify the Commission and other Member States of the bodies which they have designated for carrying out the tasks pertaining to the procedures referred to in Article 11 and the specific tasks for which the bodies have been designated. The Commission shall assign identification numbers to these bodies, here in after referred to as ‘notified bodies’. The Commission shall publish a list of the notified bodies, together with the identification numbers it has allocated to them and the tasks for which they have been notified, in the Official Journal of the European Communities. It shall ensure that the list is kept up to date.
Member States shall apply the criteria set out in Annex XI for the designation of bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonized standards shall be presumed to meet the relevant criteria. When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex XI for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).
A Member State that has notified a body shall withdraw that notification if it finds that the body no longer meets the criteria referred to in paragraph 2. It shall immediately inform the other Member States and the Commission thereof.
The notified body and the manufacturer, or his authorized representative shall lay down, by common accord, the time limits for completion of the assessment and verification operations referred to in Annexes II to VI.
The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.
Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or where a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer. In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof. The Member State shall inform the other Member States and the Commission.
The notified body shall, on request, supply all relevant information and documents including budgetary documents, required to enable the Member State to verify compliance with Annex XI requirements.
What you need to know
The first thing device manufacturers need to know is that notified bodies just do not come into being. There is no such thing as a regulatory immaculate conception. The notified bodies are chartered by the Member States from which they operate. For example, NSAI operates out of Ireland and the Irish Competent Authority is tasked with their oversight and their ongoing authority to perform approved regulatory tasks. Additionally, Member States must notify the Commission, providing the Commission with the names of approved notified bodies. Upon notification, the Commission is charged with issuing the registration number; henceforth, the birth of the notified body. This birth is then recorded in the Official Journal. Each notified body will have their own unique registration number.
The next step is for Member States to invoke Annex XI (Criterion to be met for the Designation of Notified Bodies) in regards to ensuring notified bodies operating within their jurisdiction remain in compliance with the MDD. Not unlike the notified bodies and their ability to make a device manufacturer’s life miserable during an annual audit, the Competent Authorities can do the same to notified bodies. At the end of the day, the message within the EU is now and continues to be compliance, compliance, and more compliance. Yes, the doctor knows that he continues to sound like a broken record when he climbs onto his soapbox to preach compliance.
A salient point to remember is that a Member State has the legal authority to withdraw the notification of a notified body that fails to sustain ongoing compliance with the Directive. The message being sent is clear; Member States and the Commission are looking for compliance with the Directive at all levels (yes – broken record).
Once commissioned, the notified body must establish and convey to the device manufacturer or the manufacturer’s European Authorized Representative, the frequency and time limits established for assessments/activities in which ongoing operations of device manufacturers are assessed for compliance with Annex II through Annex VI. Device manufacturers can expect these friendly visits at least once per year. Guess what? Device manufacturers also get to pay for this annual abuse. Why? Because the notified bodies work for you; and device manufacturers will pay dearly for this work.
Another mission-critical point device manufacturers need to comprehend is that their notified body has the legal right to refuse the issuance of, revoke, suspend, or withdraw a certificate issued to a device manufacturer. Although a rare event indeed, a suspended or withdrawn certificate can result in the temporary and potentially long-term interruption of a revenue stream. Ouch! If such action is pursued by the notified body, they are tasked with notifying the Competent Authority. Ouch, Ouch!
Additionally, if a notified body is able to ascertain that a device manufacturer has failed to meet the requirements delineated within the Directive or that a certificate should never have been issued; they are required to pursue an appropriate course of action, ASAP! The doctor would love to be the proverbial “fly-on-the-wall” when a notified body has the discussion with their Competent Authority, explaining how the issuance of a certificate was a mistake. Is it appropriate to use the phrase, “my bad” in Europe?
As a manufacturer, losing a certificate is not the end of the world. The notified body will ask that corrective action be taken to resolve the compliance issues. Once the notified body believes a device manufacturer has adequately corrected the objectionable conditions, the certification can be reissued. It should be noted, the Competent Authority retains the legal right to intervene when certification issues arise. Regardless, when certification issues arise, the notified body notifies the Competent Authority, the Competent Authority notifies the Member State, and the Member State notifies other Member States, and ultimately the Commission. Before long, the entire Europe is aware that a device manufacturer’s certificate(s) have been pulled. Really Big Ouch!
Finally, upon request, notified bodies are required to provide documentation and other information in support of claiming ongoing compliance, with Annex XI, to the appropriate Member State. This information will be employed by the Member State to validate the ongoing compliance with the Directive by notified bodies.
What you need to do
First and foremost, device manufacturers need to strive to sustain an ongoing state of compliance with the Directive (yes – broken record time). One major deviation received during an annual surveillance audit is all it takes to place a certificate(s) in jeopardy. If notified bodies are executing their duties diligently and according to the Directive, and the working relationship with the device manufacturer is a close and nurturing one, there should never be any surprises.
As a device manufacturer, you should be aware that not all notified bodies are created equal; but some notified bodies are clearly better than others. Organizations such as TUV-R, TUV-SUD, BSI, NSAI, and DEKRA (no, the doctor is not a paid spokesperson for these organizations) are recognized as some of the industry leaders.
Once a device application is approved, device manufacturers need to ensure all product labeling contains reference to the appropriate CE Mark. An example I presented a few paragraphs ago made reference to CE 0197 (TUV-R). As a minimum, this mark needs to be affixed to the outermost carton / box, pouch, DFU, etc. It is a legal requirement. Additionally, Dr. D recommends a review of EN ISO 980:2008 to ensure all symbols placed onto the label are correct. Another point the doctor must emphatically make is that, “The notified bodies give and the notified bodies can take away,” in regards to certificates. Remember, the CE Mark and registration number belongs to them. Device manufacturers are just renting the CE Mark, so to speak.
Finally, device manufacturers need to clearly understand the relationship between the notified body, Competent Authority, Member State, and the Commission. If devices are deemed not to be safe and effective within the EU, the Competent Authority can also authorize the suspension or withdrawing of a device manufacturer’s certificate.
For this edition of DG, Dr. D will keep it simple. There are five salient takeaways that device manufacturers need to understand:
- The notified body issues certification and the notified body can take away the certification;
- The CE Mark of registration is assigned by the Commission and belongs to the notified body;
- Once a device manufacturer receives certification they, are responsible for ensuring the CE Mark is applied to product appropriately;
- If a certificate is withdrawn, device manufacturers must remove the CE Mark of conformity; no argument or discussion is required because that is the law; and
- Competent Authorities also retain the authority to force the suspension or revocation of a certificate if devices entering into commerce in the EU are found not to be safe and effective.
Until the next installment of DG, when Dr. D will provide guidance for complying with Article 17 (CE Marking) 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.
- EN 980:2008. (2010, May). Symbols for use in the labeling of medical devices. European Standard – Prepared by: Technical Committee CEN/CLC/TC 3.