Article 19 of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Decision in Respect of Refusal or Restriction.” There are few things more frustrating for a device manufacturer then executing a market-withdraw of product. The level of frustration is quickly elevated when they are asked to remove product from the market without being given a definitive reason as to why the market withdraw needs to occur. Equally frustrating is when a manufacturer’s devices are blocked from entering market or additional restrictions enacted.

The good news for manufacturers is that under Article 19 of the Directive, Member States must quickly provide rationale as to why a product withdraw has been mandated, product entry refused, or other restrictions mandated. Additionally, the manufacturer and/or their European Authorized Representative retain the legal right to question the actions through consultation. The bad news is a Member State can mandate an expedited product withdraw due to product safety and efficacy concerns, or the topic of last week’s Devine Guidance (DG), the product in question has a wrongly affixed CE Marking.

Either way, the device manufacturer is quickly out of the market in the European Union (EU), resulting in the interruption of the proverbial revenue stream. As Dr. D often states, “Interruption of the revenue stream is a bad thing.” Device manufacturers may sometimes view the Competent Authorities in the same light as a truculent (look-it-up) dictator; however, their role is to protect the public health in the respective Member States. It is not a job to be taken lightly.

The MDD – 93/42/EEC
Article 19 – Decision in Respect of Refusal or Restriction
1. Any decision taken pursuant to this Directive:
     (a) to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations; or
     (b) to withdraw devices from the market, shall state the exact grounds on which it is based. Such decisions shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the national law in force in the Member State in question and of the time limits to which such remedies are subject.

2. In the event of a decision as referred to in paragraph 1, the manufacturer, or his authorized representative, shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measure to be taken.

What you need to know
There are two salient concepts device manufacturers need to grasp. The first concept is a Member State needs to provide the actual grounds driving the decisions made in regards to market withdraws, refusals, or restrictions. The second concept is that device manufacturers have some recourse in regards to addressing decisions made by a Member State; and that process is vetted through consultation. Hopefully, the manufacturer is consulted in advance of a Member State’s decision.

However, device manufacturers should understand that if a Member State decides that there is a significant urgency needed for a market-withdraw of product, an advance consultation with the device manufacturer and/or their authorized rep, may not always be possible. Can you say, “Interruption of revenue stream?” Regardless, Article 19 does provide an avenue for two-communications between Member States and device manufacturers when issues result in potential market withdrawals, refusals, or restrictions in the EU.

What you need to do
Dr. D is going to let the readers in on a not-so-well-kept secret. The secret is, “device manufacturers need to design and manufacture devices that are “safe, effective, and compliant” with their essential requirements, while being properly certified by their notified body!” An easy way to remember the three-key elements of the doctor’s secret is the acronym “SEC.” Yes, Dr. D knows this acronym is already used by the Securities and Exchange Commission and the Southeastern Conference. That being said, SEC also stands for “Safe, Effective, and Compliant.” The doctor likes his acronym better.

The entire process commences with a robust design that is properly validated. The process continues with the execution of clinical trials (if appropriate) to determine if the finished medical device is safe and effective. The entire process culminates with review and approval of the technical file or design dossier by the notified body and the formal issuance of certification. If shortcuts are taken, receiving approval from your notified body will be problematic. Dr. D guarantees it!

Takeaways
For this edition of DG, the doctor will leave the readers with two takeaways. Dr. D also would like to apologize in advance for his broken-record approach to drive home salient points; however, this approach worked when the doctor was a United States Marine (repetitive bouts of pain), and continues to be an effective approach today.

That said, (1) in accordance with Article 19, Member States must provide rationale in regards to decisions made that result in market withdrawals, refusals, and restrictions. (2) Device manufacturers and/or their authorized rep shall have the opportunity to consult with the Member State in regards to the decisions made.

Until the next installment of DG, when Dr. D will provide guidance for complying with Article 20 (Confidentiality) of Council Directive 93/42/EEC, the MDD – cheers from Dr. D and best wishes for continued professional success.

References:

1. 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
2. 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.