So what in the heck does lodge mean Dr. D? Isn’t that a place where folks hangout after a long day of skiing? According to Merriam Webster’s Dictionary, lodge (in this application) is a transitive verb with the meaning “to establish, or settle, or place.” Simply stated, if your EU authorized rep spends the day skiing in St. Moritz, he or she can stop in the lodge, at the end of the day, order a beer, and lodge a device application with your notified body.
All kidding aside, in this week’s guidance Dr. D will explore the requirements associated with the EC Type-Examination process. Not trying to over simplify the process, there are a few basic concepts that the manufacturers will need to grasp in support of complying with Annex V:
- Device manufacturers are actually required to have a notified body;
- The notified body will request device samples a necessary;
- Specific information is required as part of the application process;
- The notified body will exam the product and supporting documentation; henceforth, the title for Annex V;
- A valid Design Examination Certificate (DEC) is required for market entry into the EU; and
- Product changes require the review and approval of the notified body.
— the name and the address of the manufacturer and the name and address of the authorized representative if the application is lodged by the representative,— the documentation described in section 3 needed to assess the conformity of the representative sample of the production in question, hereinafter referred to as the ‘type’, with the requirements of this Directive. The applicant shall make a ‘type’ available to the notified body. The notified body may request other samples as necessary, and— a written declaration that no application has been lodged with any other notified body for the same type.
— a general description of the type, including any variants planned,— all documentation referred to in Annex III, section 3, indents 3 to 13, and— in the case of devices for self-testing, the information referred to in Annex III, section 6.1.
4.1. examine and assess the documentation and verify that the type has been manufactured in conformity with that documentation; it shall also record the items designed in conformity with the applicable provisions of the standards referred to in Article 5, as well as the items not designed on the basis of the relevant provisions of the abovementioned standards;4.2. perform or have performed appropriate examinations and the tests necessary to verify whether the solutions adopted by the manufacturer meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied; if the device is to be combined with other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when combined with anysuch device(s) having the characteristics specified by the manufacturer;4.3. carry out or ask for the appropriate examinations and the tests necessary to verify whether, if the manufacturer has chosen to apply the relevant standards, these have actually been applied; and4.4. agree with the applicant on the place where the necessary examinations and tests will be carried out.
6.1. Changes to the approved device must receive further approval from the notified body which issued the EC type-examination certificate wherever the changes may affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the device. The applicant shall inform the notified body which issued the EC type-examination certificate of any such change made to the approved device. This new approval shall take the form of a supplement to the initial EC type-examination certificate.
- Product description;
- Planned product line-extensions;
- Design information (device characteristics, materials, device performance boundaries, method of manufacturing, verification activities, validation activities, drawing, and associated design-relevant documentation);
- Incorporation of human tissue, including source (if applicable);
- Risk analysis and application of risk assessment tools (use EN ISO 14971:2009);
- Sterilization method (if applicable);
- Special microbiological state (if applicable);
- Product cleanliness;
- Results of design calculations;
- Results of inspections;
- If use in conjunction with another device (combination);
- Test reports;
- Performance evaluation data;
- Product labeling;
- Product Instructions for Use (IFU); and
- The results of stability studies must be considered and if applicable included in the technical documentation package (the doctor prefers the term Technical File).
- Do your homework and select a qualified firm (located in the EU) as a European authorized representative. Make sure a contact is drawn up and signed that clearly delegates the roles and responsibilities of each party.
- Select and contract with a recognized notified body, e.g., BSI (Dr. D is not a paid spokesperson for BSI). Remember, the partnership with the notified body is not unlike a marriage, so choose wisely.
- A medical device that is safe and effective in its intended use commences with the design. Make sure the design and development process is robust.
- Documentation is everything in support of the application process. Make sure all aspects of the organization are documented by well-written procedures. Additionally, make sure accurate records of all product testing, inspection, and manufacturing (including validation protocols and reports) are collected and retained.
- Do Not, I repeat, Do Not affix the CE Mark of conformity to the product packaging until the DEC has been issued by the notified body.
- Seldom, if ever, do product designs remain static. Make sure that all design changes, including manufacturing processes, are reviewed and approved in advance by your notified body.
Since the EU requires device manufacturers to partner with a notified body for most products, one cannot play in the EU sandbox without one. Considering the IVDD is, in the doctor’s humble opinion, the quirkiest of the three Medical Device Directives, it would be absolutely insane to attempt to navigate the IVDD regulatory requirements without the assistance of a qualified notified body. Remember to choose well, because just like any bad marriage, a divorce from the notified body can be expensive.
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Annex VI (EC Verification) 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.