Article 3 of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) establishes the essential requirements for medical devices, as delineated within Annex I of the Directive. Similar to the previous edition of Devine Guidance (DG), Article 3 is eloquent in its simplicity; in fact, just like Article 2, it is a one-sentence Article. Man, Dr. D enjoys the simple things in life, including regulations one can easily read and understand.
Now granted my beliefs, in regards to regulatory compliance, have ossified over the years; however, it is still possible to teach “old dogs” or in my case “old PhD’s” new tricks. For readers used to working within the realm of the Quality System Regulation (QSR), the doctor can relate to some level of alterity (look-it-up if you must) experienced, when being introduced to the MDD for the first time. That being said, I hope you enjoy reading this edition of DG as the doctor provides understanding and guidance for establishing and meeting essential requirements.
The MDD – 93/42/EEC
Article 3 – Essential Requirements
The devices must meet the essential requirements setout in Annex I which apply to them, taking account of the intended purpose of the devices concerned.
Article 3 of the MDD establishes the essential requirements for the design and manufacturability of devices entering into the European Union (EU) for commerce, including the consideration of risk. As Dr. D stated in the opening paragraph, the concept mandated by Article 3 of the Directive is an easy one to digest, with or without sugar on top (Dr. D apologizes for the bad humor). The competent authorities, for each member state, want to ensure medical devices that reflect robust safety and efficacy attributes are the only ones making their way into the hands of healthcare practitioners within the EU. After all, similar to FDA, the primary goals of the competent authorities in Europe is to regulate medical devices and protect public health, period. Additionally, mandating the need to establish and maintain essential requirements can be viewed as risk mitigation. That said, Article 3 of the Directive invokes the need to comply with the following salient components. I strongly suggest that each of you read Annex I, in its entirety so you can absorb all of the requirements needed to comply with Article 3 of the Directive.
Annex I – Essential Requirements – Salient Components
I. General requirements
1. Devices designed and manufactured so they meet their intended use including the consideration of risk;
2. Device design and construction conforming with safety principles, considering the state-of-the-art;
3. Devices achieving performance expectations, including the acceptable design, manufacture and packaging;
4. Performances characteristics not adversely influencing device safety and efficacy;
5. Devices designed, manufactured, and packaged to ensure product preservation during transport and storage;
6. Weighing any undesirable side-effect, when determined to be an acceptable risk, against expected device performance; and
6a. Demonstration of conformity with clinical requirements delineated within Annex X.
Annex II: Requirements Regarding Design and Construction
7. Chemical, Physical, and Biological Properties;
8. Infection and Microbial Contamination;
9. Construction and Environmental Properties;
10. Devices with a Measuring Function;
11. Protection Against Radiation;
12. Requirements for Medical Devices Connected to or Equipped with an Energy Source; and
13. Information Supplied by the Manufacturer.What You Need to Do.
Establishing essential requirements is not rocket science; however, device manufacturers need to document compliance to the requirements. Can you guess where these requirements are documented? If you said the essential requirements checklist (ERC), you would be correct. Difficult concept to understand right, compliance to the essential requirements is documented in the ERC. In fact, all of the device testing, from concept to production acceptance is documented within the ERC, including compliance to the quality system requirements, risk management, product packaging, product labeling, etc.
Device manufacturers are also expected to keep the ERC current. Fail to do so, and you expect to receive a deviation, when your notified body arrives for their annual friendly visit. Additionally, although not required by the Directive, it is strongly recommended that harmonized standards be considered and hopefully employed, when qualifying medical devices. In many cases, compliance, to some of the harmonized standards, i.e., EN ISO 13485:2003, EN 980:2008, EN ISO 14971:2009, although optional, device manufacturers really need to comply with these standards. Dr. D would never want to attempt to pursue device registration without compliance with these, what the doctor calls “corner-stone standards” being achieved. Regardless, once the ERC has been completed, it will need to be submitted to your notified body along with the Declaration of Conformity, Technical File, and/or Design Dossier, as part of the approval process.
The ERC should also be categorized as a dynamic document because content will change over time as standards are revised. Remember and I repeat, the ERC will be reviewed by your notified body during their annual surveillance visit and on-site audit of Technical Files. Yes – I know Dr. D may be belaboring the point of keeping the ERC current; however, it is an important concept to retain. Finally, remember to incorporate a pointer to the ERC into each Technical File and/or Design Dossier. As a minimum, the document number for the ERC should be referenced. One final thought, countries like Australia. TGA requirement, want the standards employed for establishing compliance with essential requirements listed on the actual Declaration of Conformity (TGA – DoC). Please ensure the standards listed on the ERC and DoC match. Again, simple concept but I cannot count the number of times Dr. D has personally reviewed these documents and find they do not match.
There are just three takeaways from this edition of DG that need to be retained.
- Article 3 of the Directive establishes the need for compliance to Essential Requirements with a mandate to comply with Annex I.
- Completion of the ERC is not optional, it is a requirement, and you are expected to keep the checklist current. Your notified body will review the checklist and issue deviations, if the information depicted is not accurate or properly maintained, e.g., references to withdrawn standards.
- Dr. D strongly suggests adhering to harmonized standards. Trust me, it will make your path to compliance much easier.
In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG, when Dr. D will provide guidance for complying with Article 4 (free movement, devices intended for special purposes) of Council Directive 93/42/EEC, the MDD – cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2010, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- 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.
- EN 980:2008. Symbols to be used in the labeling of medical devices.
- EN ISO 13485:2003. Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).
- EN ISO 14971:2009. Medical devices – application of risk management to medical devices (ISO 14971:2009).