Annex XI (Criteria to be met for the Designation of Notified Bodies) of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD), is all about the notified bodies. Not unlike that weird aunt or uncle everyone claims to have, device manufacturers wishing to enter into the European device market must have a notified body. Yes, I know, bad analogy Dr. D, but hey, this is my column.
As this series of articles on the MDD is nearing its end (one week remaining), the doctor has mentioned the importance of the notified bodies on numerous occasions; and the importance of selecting one a device manufacturer can work closely with as a partner. Remember, once a notified body has been selected, this partnership is not unlike a marriage. A bad marriage, ending in divorce, can be extremely costly to device manufacturers. Trust Dr. D when I say the pain and costs associated with moving to a new notified body are significant.
That being said, this edition of DG will dive into the regulatory responsibilities all notified bodies must fulfill, under Annex XI. One final thought before diving into Annex XI, some device manufacturers, and you know who you are, at times attempt to rebel against the onerous requirements of the MDD; however, the continued contumaciousness (look-it-up) will not result in scoring brownie points with the notified bodies.
The MDD – 93/42/EEC
ANNEX XI – Criteria to be met for the Designation of Notified Bodies
1. The notified body, its Director and the assessment and verification staff shall not be the designer, manufacturer, supplier, installer or user of the devices which they inspect, nor the authorized representative of any of these persons. They may not be directly involved in the design, construction, marketing or maintenance of the devices, nor represent the parties engaged in these activities. This in no way precludes the possibility of exchanges of technical information between the manufacturer and the body.
2. The notified body and its staff must carry out the assessment and verification operations with the highest degree of professional integrity and the requisite competence in the field of medical devices and must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection, especially from persons or groups of persons with an interest in the results of the verifications.
Should the notified body subcontract specific tasks connected with the establishment and verification of the facts, it must first ensure that the subcontractor meets the provisions of the Directive and, in particular, of this Annex. The notified body shall keep at the disposal of the national authorities the relevant documents assessing the subcontractor’s qualifications and the work carried out by the subcontractor under this Directive.
3. The notified body must be able to carry out all the tasks assigned to such bodies by one of Annexes II to VI and for which it has been notified, whether these tasks are carried out by the body itself or on its responsibility. In particular, it must have the necessary staff and possess the facilities needed to perform properly the technical and administrative tasks entailed in assessment and verification. This presupposes the availability of sufficient scientific staff within the organization who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified, having regard to the requirements of this Directive and, in particular, those set out in Annex I. It must also have access to the equipment necessary for the verifications required.
4. The notified body must have:
— sound vocational training covering all the assessment and verification operations for which the body has been designated,
— satisfactory knowledge of the rules on the inspections which they carry out and adequate experience of such inspections,
— the ability required to draw up the certificates, records and reports to demonstrate that the inspections have been carried out.
5. The impartiality of the notified body must be guaranteed. Their remuneration must not depend on the number of inspections carried out, nor on the results of the inspections.
6. The body must take out civil liability insurance, unless liability is assumed by the State under domestic legislation or the Member State itself carries out the inspections directly.
7. The staff of the notified body are bound to observe professional secrecy with regard to all information gained in the course of their duties (except vis-à-vis the competent administrative authorities of the State in which their activities are carried out) pursuant to this Directive or any provision of national law putting it into effect.
What you need to know
The good news is that device manufacturers only need to acknowledge that seven basic elements associated with Annex XI exist, since this Annex pertains only to the notified bodies. It is under this Annex, the Competent Authorities can unload a world of pain on notified bodies that fail to meet their regulatory requirements under the Directive.
One point Dr. D would like to make is that device manufacturers should be auditing their notified bodies to ensure that notified bodies are remaining in compliance with the MDD. Besides, this is an opportunity for device manufacturers to switch up the relationship and place their notified bodies into the “audit hot seat,” including the assignment of corrective action, even if it is just for a day. The only downside is that although device manufacturers pay their notified bodies for audits, it is unlikely device manufacturers will be able to extract payment for returning the audit favor.
As stated in the previous section, there are a few salient requirements notified bodies are required to comply with under Annex XI.
- For starters, notified bodies are not permitted to design, manufacture, supply, install, use, or act as the authorized representative for devices they are tasked with the review and approval. This is what Dr. D calls the proverbial “separation of church and state rule.”
- The staff of the notified body must be qualified to perform accurate assessments on the medical devices they are contracted to review. Financial inducements employed to drive device application approvals, a.k.a., “bribery” is not permitted under the Directive; and will probably result with a number of people being fitted for orange jumpsuits.
- Notified bodies must be able to perform their duties as delineated under Annexes II, III, IV, V, and VI. To accomplish these duties, the expectation under the Directive is that notified bodies retain sufficient headcount, equipment, and facilities.
- Notified bodies must have adequate training, knowledge, and experience, including the ability to create, issue, and manage certificates.
- The notified body must always be impartial, regardless of the payments received from device manufacturers.
- The notified body must purchase and retain liability insurance.
- The notified body must observe appropriate levels of professional secrecy; so Dr. D always recommends having a signed Non-Disclosure Agreement (NDA) in place.
What you need to do
By the way, did the doctor mention that device manufacturers must contract with and pay their notified body for their services (just kidding)? From a device manufacturer’s perspective, there is really nothing for you to do in regards to Annex XI. Obviously, bribery is out of the question. However, a point Dr. D has made on several occasions must be strongly considered. Device manufacturers need to be choosey when selecting a notified body. This will be a long-term relationship, so selecting a competent and well-recognized notified body should result in excellent support when navigating the European regulatory waters. Although Dr. D is not a paid spokesperson for these organizations, the doctor has worked with TUV-R, BSI, DEKRA, and NSAI. Each of these organizations has extensive experience reviewing applications for market entry into the EU. That being said, whatever the notified body choice, pick one and stick with them. Why? Because changing a notified body midstream can be expensive.
The takeaway from this edition of DG is extremely simple. Device manufacturers can take some comfort in knowing that notified bodies are also held to a high standard under the Directive. Trust Dr. D when I say, the Competent Authorities have the ability to turn-up the heat for notified bodies that fail to meet their regulatory obligations under the Directive. Finally, please do not forget to add your notified body to your audit schedule. It is actually quite exhilarating to put the notified body through the ringer during an audit. However, remember the notified bodies are obliged to return the favor once each year, so be gentle.
Until the next installment of DG, the last article in the MDD series, when Dr. D will provide guidance for complying with Annex XII (CE Marking of Conformity) 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.