Article 21 of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Repeal and Amendment of Directives.” Under Article 21, medical device manufacturers retain the right to repeal or amend any of the Directives they just do not like or wish to comply with. Okay, Dr. D is just kidding; but, I do believe I have your undivided attention.
Simply put, Article 21 delineates the repeal and actual changes made to Directives and Articles within the Directives, period. That being said, the guidance provided for this week will be extremely brief. There really is no need for interpretation or an in-depth understanding of Article 21, other than it exists and provides granularity in regards to changes made to Directives. Not wanting the readers to take the axiomatic (look-it-up) principles of the MDD for granted, Dr. D always recommends reading the Articles of the Directive, regardless of their perceived applicability to a device manufacturer’s quality management system (QMS).
The MDD – 93/42/EEC
Article 21 – Repeal and Amendment of Directives
1. Directive 76/764/EEC is hereby repealed with effect from 1 January 1995.
2. In the title and Article 1 of Directive 84/539/EEC, ‘human or’ is deleted. In Article 2 of Directive 84/539/EEC, the following subparagraph is added to paragraph 1: ‘If the appliance is at the same time a medical device within the meaning of Directive 93/42/EEC (*) and if it satisfies the essential requirements laid down therein for that device, the device shall be deemed to be in conformity with the requirements of this Directive.
3. Directive 90/385/EEC is hereby amended as follows:
1. In Article 1 (2) the following two subparagraphs are added:’
(h) “placing on the market” means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;
(i) “manufacturer” means the natural or legal person with responsibility for the design, manufacture, packaging and labeling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;
2. In Article 9 the following paragraphs are added:
1. During the conformity assessment procedure for a device, the manufacturer and/or the notified body shall take account of the results of any assessment and verification operations which, where appropriate, have been carried out in accordance with this Directive at an intermediate stage of manufacture.
2. Where the conformity assessment procedure involves the intervention of a notified body, the manufacturer, or his authorized representative established in the Community, may apply to a body of his choice within the framework of the tasks for which the body has been notified.
3. The notified body may require, where duly justified, any information or data which is necessary for establishing and maintaining the attestation of conformity in view of the chosen procedure.
4. Decisions taken by the notified bodies in accordance with Annexes II and III shall be valid for a maximum of five years and maybe extended on application, made at a time agreed in the contract signed by both parties, for further periods of five years.
5. By derogation from paragraphs 1 and 2 the competent authorities may authorize, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 and 2 have not been carried out and the use of which is in the interest of protection of health.’
3. The following Article 9a is inserted after Article 9: ‘Article 9a
1. Where a Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9, it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures. These measures shall be adopted in accordance with the procedure referred to in Article 7 (2) of Directive 93/42/EEC (*).
2. The Commission shall inform the Member States of the measures taken and, where appropriate, publish the relevant parts of these measures in the Official Journal of the European Communities.
4. Article 10 shall be amended as follows: —the following subparagraph shall be added to paragraph 2: ‘Member States may however authorize manufacturers to start the clinical investigations in question before the expiry of the 60- day period, provided that the Ethical Committee concerned has delivered a favorable opinion with respect to the investigation program in question. ‘, —the following paragraph shall be inserted: ‘2a. The authorization referred to in the second subparagraph of paragraph 2 maybe subject to approval by the competent authority’;
5. The following is added to Article 14: ‘In the event of a decision as referred to in the previous paragraph the manufacturer, or his authorized representative established in the Community, shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measures to be taken. ‘
What you need to know
Hopefully, all device manufacturers have taken the appropriate steps to ensure all of the amendments to the MDD, which went into force in March of 2010, have been incorporated into their businesses. If not, I am sure the notified bodies, for the offending device manufacturers, have reacted accordingly through the issuance of major deviations.
Regardless, device manufacturers need to know and understand that Article 21 delineates the changes made to Directives. Yes – I know Dr. D once again sounds like that proverbial broken record; however, the doctor’s message is clear; “Compliance to all Articles of the MDD is not optional. Compliance is mandated by law”
What you need to do
Broken-record-time again, “Device manufacturers need to read and understand all of Articles associated with the MDD.” As the doctor alluded to in the previous paragraph, if a device manufacturer has been proactive and worked toward compliance with the revised MDD and all of the Articles, then there will not be any issues. For device manufacturers that still find themselves on the “south-side” of compliance, what in the heck are you waiting for, compliance pixie dust? Dr. D strongly suggests that device manufacturers perform a quick sanity check in regards ensuring all of the changes depicted in Article 21 have been adequately addressed within your organizations.
Similar to the last edition of DG, the doctor will leave the readers with just one takeaway. Article 21 of the MDD delineates the repeal of and amendments to Directives. It is incumbent upon device manufacturers to ensure all of these changes have been captured and adequately addressed within your organizations. If your organization has not implemented these changes, Dr. D suggests you “Get er done.” (Thank you Larry the Cable Guy for those famous words of wisdom).
Until the next installment of DG, when Dr. D will provide guidance for complying with Article 22 (Implementation, Transitional Provisions) of Council Directive 93/42/EEC, the MDD – 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.