Article 13 (Particular Health Monitoring Measures) of the IVDD (98/79/EC), is all about protecting the public health and safety of the citizens of each Member State. In short, products can be prohibited, restricted, or required to conform to particular requirements in the interest of protecting public health and safety.
Remember, Dr. D is a big proponent of ensuring IVDD manufacturers design, develop, and manufacture devices that are safe and effective in their intended use. Heck, Dr. D thinks all devices should be safe and effective in their intended use. This is particularly true for diagnostic devices that should never cause harm to the patient or user. Now the doctor is not asking IVDD manufacturers to genuflect (look-it-up) before the regulatory gods of the EU, in the pursuit of device application approvals; however, Member States are entrusted with a solemn duty to protect the health and safety of their citizens.
The IVDD – 98/79/EC
Article 13 – Particular Health Monitoring Measures
Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and
safety and/or to ensure that public health requirements are observed pursuant to Article 36 of the Treaty, the availability of such products should be prohibited, restricted or made subject to particular requirements, it may take any necessary and justified transitional
measures. It shall then inform the Commission and all the other Member States, giving the reasons for its decision. The Commission
shall consult the interested parties and the Member States and, where the national measures are justified, adopt necessary Community
Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 7(4).
What IVDD medical device manufacturers need to know
Manufacturers of IVDDs need to know and understand that just because a device application has been approved, the approval does not equate to forever being permitted access into the European IVDD market. If an IVDD, or any device for that matter, is deemed not to be safe and effective, Member States will pursue a path of appropriate action. The doctor has already established the salient requirement for Member States to protect the health and safety of their citizens from IVDDs deemed not to be safe and effective. Additionally, Member States are required to inform other Member States and the Commission of their decisions in regards to problem devices and the need to protect the health and safety of their citizens. Furthermore, it is the Commission’s responsibility to consult with interested parties (a.k.a., the device manufacturers) and the Member States, as appropriate. If a Member State’s actions are determined to be justified, the actions/measures taken shall be considered for adoption.
Finally, when deemed appropriate by the Commission, measures designed to amend non-essential elements of the IVDD, through the act of supplementing it, shall be adopted in accordance with Article 7. What in the heck does that mean Dr. D? Remember, Article 7 refers to the Commission and the assistance of the Committee on Standards and Technical Regulations and their authority. Basically, this piece of EU legalese allows for the Commission to act as appropriate to amend and revise standards.
What IVDD medical device manufacturers need to do
Dr. D will climb onto his soapbox and turn on his old phonograph because it is now broken-record time. What IVDD manufacturers need to do is simple, design and manufacture quality devices. Medical devices must always be safe and effective in their intended use. That being said, why would anyone want to test the regulatory gods by forcing them to invoke Article 13 of the IVDD? It is not going to be worth the pain as devices are placed under significant scrutiny and potentially forced from the EU market. Can you say RECALL? Excuse me, can you say MARKET WITHDRAW? Seriously, IVDDs should never be in a position to hurt the patient or user, never, never, never! But hey, occasionally &#$@ happens. The best advice the doctor can offer to IVDD manufacturers is that if a Competent Authority invokes Article 13, work closely with your notified body and the Competent Authority to address and resolve device issues immediately. Can you say ASAP?
Article 13 is a tool that can be employed by Member States to protect the health and safety of their citizens. IVDDs, being diagnostic devices, should never place the patient or user in harm’s way. Unfortunately, the device industry is far from being utopic, so manufacturers need to be ready to quickly respond to and act with integrity when the Competent Authorities come knocking on the door with concerns about device safety and efficacy.
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Article 14 (Amendments to Annex II, and Derogation Clause) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – cheers from Dr. D and best wishes for continued professional success.
- Commission Decision 2010/227/EU. (2010, April). Commission decision of 19 April 2010 on the European Databank on Medical Devices (Eudamed). Retrieved December 9, 2011, from http://eur-lex.europa.eu.
- 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 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.