IVDD Article 22 – Implementation, Transitional Provisions
Article 22 (Implementation, Transitional Provisions) of the IVDD (98/79/EC) delineates the salient requirement that Member States must comply with this Directive. Compliance to Directives is not optional for the manufacturers of IVDDs and the same holds true for all 27 Member States. Isn’t life grand?
Although the IVDD was originally drafted in 1998 (henceforth the 98 in 98/79/EC), compliance to the provisions of this Directive was not required until June of 2000. Considering Dr. D is sometimes known for his lack of duende (look-it-up), as the doctor has repeatedly failed all attempts at making it through charm school, the doctor hopes the readers enjoy this week’s brief edition of Devine Guidance (DG).
Although the IVDD was originally drafted in 1998 (henceforth the 98 in 98/79/EC), compliance to the provisions of this Directive was not required until June of 2000. Considering Dr. D is sometimes known for his lack of duende (look-it-up), as the doctor has repeatedly failed all attempts at making it through charm school, the doctor hopes the readers enjoy this week’s brief edition of Devine Guidance (DG).
That being said, what is good enough for the goose (the Competent Authorities), is good enough for the gander (device manufacturers wanting to swim in the waters of the European device market), so enjoy!
The IVDD – 98/79/EC
Article 22 – Implementation, Transitional Provisions
1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 7 December 1999. They shall immediately inform the Commission thereof.Member States shall apply these provisions with effect from 7 June 2000.When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive.3. The Committee referred to in Article 7 may undertake its tasks from the date of entry into force of this Directive. The Member States may take the measures referred to in Article 15 as from the entry into force of this Directive.4. Member States shall take the necessary action to ensure that the notified bodies which are responsible pursuant to Article 9 for conformity assessment take account of any relevant information regarding the characteristics and performance of such devices, including in particular the results of any relevant test and verification already carried out under pre-existing national law, regulations or administrative provisions in respect of such devices.5. During a period of five years following the entry into force of this Directive, Member States shall accept the placing on the market of devices which conform to the rules in force in their territory on the date on which this Directive enters into force. For an additional period of two years, the said devices may be put into service.
What IVDD medical device manufacturers need to know
Similar to last week’s guidance, device manufacturers have to do “nothing!” Article 22 is geared toward each of the Member States and the transcribing of the requirements of this Directive into their national law. As stated in the introduction to this week’s DG, compliance with the IVDD, by Member States, is mandated by law. Member States are also required to provide the Commission with the actual text of the provisions they employ to facilitate the adoption of this Directive into their national law(s).
Additionally, Member States must ensure that notified bodies falling under their jurisdiction must consider device characteristics, performance, testing, and verification activities performed under pre-existing national law(s) employed by each Member State. There was a time-period associated with this Directive (five years), in which devices previously approved under a Member State’s national law, were deemed to be acceptable under this Directive. As one can quickly ascertain from the June 2000 date for Directive applicability (12 years ago for those that might be mathematically challenged), this grace period has long-since expired.
What IVDD medical device manufacturers need to do
As previously stated, device manufacturers really have nothing to do in regards to Article 22 of the IVDD, other than to know it exists. So once again the keyword is “nothing!”
Now please do not interpret Dr. D’s understatement of this Article’s importance as a lack of caring. The simple truth is device manufacturers have plenty on their proverbial plates, like just trying to design, manufacture, and distribute medical devices that are safe and effective in their intended use. And frankly, for some device manufacturers that is challenge enough.
However, the doctor also believes that regardless of an Article’s relevance, quality and regulatory folks should still be aware of all content delineated within a Directive; and understand how each of the Articles influences their organization. Failure to do so will eventually manifest itself into written deviations, flowing freely, from your notified body, for failure to comply with the IVDD.
In fact, failure to comply with any Directive will always be problematic. Duh, Duh-Duh, consider the last sentence to be rocket science. By the way, did the doctor mention that the notified bodies work for the device manufacturers? Device manufacturers pay their notified bodies handsomely and should always take advantage of their notified body’s regulatory knowledge base.
Takeaways
The takeaway from this week’s guidance is “nothing!” The doctor is just kidding. Just to reiterate a point, device manufacturers, regardless of an Article’s applicability, must be versed in all aspects of the IVDD. Remember, device manufacturers have enough on their plates in regards to designing, manufacturing, and distributing devices that are safe and effective. However, compliance with the IVDD also counts and is mandated by law.
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Articles 23 and 24 of the IVDD, cheers from Dr. D and best wishes for continued professional success.
References:
- 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.
- Devine, C. (2011). Devine Guidance series on complying with the MDD. 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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