Column - IVDD Annex V (EC Type - Examination)

Annex V (EC Type-Examination) is all about examination. Who knew? Seriously, notified bodies are required to examine and certify that samples provided as representative of the device manufacturer’s manufacturing process actually comply with all aspects of the IVDD. Like most products entering into the European Union (EU) market, a device manufacturer or their EU authorized representative must “lodge” an application with their notified body.

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.

Hopefully, Dr. D’s piquant (look-it-up) written commentary on regulatory compliance will make a dull subject interesting. Enjoy!

The IVDD – 98/79/EC

Annex V – EC Type-Examination

1. EC type-examination is the part of the procedure whereby a notified body ascertains and certifies that a representative sample of the production envisaged fulfills the relevant provisions of this Directive.

2. The application for EC type-examination shall be lodged by the manufacturer or by his authorized representative with a notified body. The application shall include:

— 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.

3. The documentation must allow an understanding of the design, the manufacture and the performances of the device. The documentation shall contain the following items in particular:

— 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. The notified body shall:

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 any

such 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; and

4.4. agree with the applicant on the place where the necessary examinations and tests will be carried out.

5. If the type conforms to the provisions of this Directive, the notified body shall issue the applicant with an EC type-examination certificate. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions of validity and the data needed for identification of the type approved. The relevant parts of the documentation shall be annexed to the certificate and a copy shall be kept by the notified body.

6. The manufacturer shall inform the notified body without delay if it has obtained information about changes to the pathogen and markers of infections to be tested, in particular as a consequence of biological complexity and variability. In this connection, the manufacturer shall inform the notified body whether any such change is likely to affect the performance of the in vitro device concerned.

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.

7. Administrative provisions: Other notified bodies may obtain a copy of the EC type-examination certificates and/or the supplements thereto. The annexes to the certificates must be available to the other notified bodies on reasoned application, after the manufacturer has been informed.

What IVDD medical device manufacturers need to know

Compliance with Annex V commences with two simple concepts. Concept number one, device manufacturers that do not have a manufacturing presence in the EU must contract with and retain an EU authorized rep. Concept number two, device manufactures need to select and contract with a recognized notified body. Once the EU authorized rep and notified body are in place, then and only then can the device manufacturer “lodge” the device application with the notified body.

Similar to previously discussed annexes, the application contains specific pieces of information relevant to the product the device manufacturer wishes to enter into commerce within the 27-Member States that encompass the EU. The process starts off with providing the basic requirements such as manufacturer and EU authorized rep name and address. An extremely important point that needs to be made by the doctor is the written declaration relating to having just one device application. Device manufacturers are not permitted under this Directive (or the other two Device Directives) to have multiple applications for the same product at the same time. Remember, their sandbox, their rules.

Additionally, specific device information must be included in the application process. The doctor strongly suggests revisiting the DG posted two weeks ago on Annex III. For those of you not wanting to be nostalgic and revisit the past (even two-short weeks ago) Dr. D has taken the liberty to cut-and-paste the requirements. As a minimum:

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).

Furthermore, the notified body is required to actually examine (henceforth the title of Annex V) the documentation submitted to ensure product conformity with the requirements of this Directive. The examination process may include additional testing on samples provided by the manufacturer. Can you say expensive? Did the doctor happen to mention that notified bodies are compensated for their efforts?

Finally, if the examination process results in a positive outcome, the notified body will issue the DEC. Depending on the notified body, the certificate will be valid for a period of three to five years. However, if a device manufacturer fails to live up to all of the regulatory requirements delineated within the IVDD, the notified body can revoke the DEC. A simple way to remember the concept is to memorize a quote from Dr. D; “The notified body giveth, and the notified body taketh away.” One final note worth mentioning, changes to an approved device requires the review and approval by the notified body. If the notified body agrees with the changes, a supplement to the original DEC will be provided.

What IVDD medical device manufacturers need to do

For starters, the doctor recommends something simple like “Compliance.” Seriously, Dr. D cannot count the number of times I have seen organizations taking shortcuts versus just putting effective systems and tools into place to drive compliance. If a device manufacturer does not have an EU authorized rep or a notified body, no worries, entry of IVDD products into the EU is just not going to happen. However, those organizations wishing to participate in the European IVDD device market will take the following points to heart:

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.

Takeaways

For those of you that read DG on a weekly basis, Dr. D is quite sure the message of compliance is not optional is coming through loud and clear. It really makes no difference in regards to the regulation or standard i.e., one of the three European Device Directives, 21 CFR, Part 820, or MHLW’s Ministerial Ordinance 169, compliance is mandatory.

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.

References:

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.

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