Dr. D also guesses that it may be correct to surmise if a notified body issues a DEC, then it is a realistic expectation for the manufacturer of devices to actually comply with the Directive. After all folks, what part of compliance is not being understood? The doctor recommends that instead of casting aspersions (look-it-up) and heaping maledictions (look-it-up) upon the notified bodies; try complying with the Directive. That being said, a few of the requirements delineated under Annex VI of the IVDD are as follows.
- Make sure to establish policies, procedures, and protocols prior to commencing with the manufacturing process.
- Make sure testing and controls are adequately defined.
- Make sure to establish a post-market surveillance program.
- Make sure the notified body performs the appropriate examination, including testing, of products.
- Make sure the sample plans selected by the notified body are realistic and practical.
- Make sure the CE mark is affixed onto the packaging of approved products.
- Make sure manufacturing occurs in homogeneous batches.
2.1. The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which conform to the type described in the EC type-examination certificate and the requirements of the Directive which apply to them. Before the start of manufacture, the manufacturer must prepare documents defining the manufacturing process, in particular as regards sterilization and the suitability of starting materials, where necessary, and define the necessary testing procedures according to the state of the art. All the routine, pre-established provisions must be implemented to ensure homogeneous production and conformity of the products with the type described in the EC type-examination certificate and with the requirements of this Directive which apply to them.2.2. To the extent that for certain aspects the final testing according to section 6.3 is not appropriate, adequate process testing, monitoring and control methods shall be established by the manufacturer with the approval of the notified body. The provisions of Annex IV, section 5, shall apply accordingly in relation to the abovementioned approved procedures.
5.1. Every product is examined individually and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests must be carried out in order to verify the conformity of the products with the EC type described in the type-examination certificate and with the requirements of the Directive which apply to them.5.2. The notified body must affix, or have affixed, its identification number to each approved product and must draw up a written certificate of conformity relating to the tests carried out.
6.1. The manufacturer must present the manufactured products in the form of homogeneous batches.6.2. One or more random samples, as necessary, are taken from each batch. The products which make up the sample are examined and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests must be carried out to verify, where appropriate, the conformity of the products with the type described in the EC type-examination certificate and with the requirements of the Directive which apply to them in order to determine whether to accept or reject the batch.6.3. Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling scheme will be established by the harmonized standards referred to in Article 5, taking account of the specific nature of the product categories in question.6.4. If the batch is accepted, the notified body affixes, or has affixed its identification number to each product and draws up a written certificate of conformity relating to the tests carried out. All products in the batch may be put on the market except any in the sample which failed to conform.If the batch is rejected the competent notified body must take appropriate measures to prevent the batch from being placed on the market. In the event of frequent rejection of batches, the notified body may suspend the statistical verification.The manufacturer may, on the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
Now for some bad news, if the samples extracted from a batch fail testing, the notified body will block the entry of the rejected batch from entering the EU market. The notified body will probably adjust their sampling plan as well. The moral of this story is quite simple, always manufactured devices that are safe and effective in their intended use; or in the case of IVDDs capable of producing accurate and repeatable results; otherwise, affixing the CE mark to product is always going to be problematic.
Now the doctor is going to climb out onto that proverbial limb again this week and assume device manufacturers are prescribing to the philosophy of manufacturing in homogeneous batches. If so good, if not what are you thinking? Regardless, the notified body is going to evaluate the device manufacturer’s approach to batch management to determine appropriate sample sizes for verification testing. Make sure, as a device manufacturer, you participate in the sample-size determination process up front; otherwise, you will be sorry.
Dr. D is now going to climb a little higher into the tree and climb out onto another limb by assuming device manufacturers have a post-market surveillance program. If not, then my question would be what are your notified body’s thinking? Sorry notified bodies. Finally, once the notified body has determined through the verification process that a device is acceptable to place onto the market, the last step is to affix the CE mark of conformity. However, if test results lead the notified body to the conclusion that a device batch is not suitable for entry into the EU market, do not pass go or collect $200. Instead, it’s back to the proverbial drawing board. Sorry but there are no Mulligans in medical device manufacturing.
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Annex VII (EC Declaration of Conformity) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – 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.
- Devine, C. (2011). Devine guidance for complying with the European medical device directive – MDD. Charleston, SC: Amazon.
- Devine, C. (2012). Devine Guidance series on complying with the IVDD. Published in The Medical Device Summit.
- 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