Well (deep subject, the doctor knows), I know many of the readers were wondering about Dr. D’s next series. The doctor really wanted to make this next series an enjoyable surprise. That being said, surprise, surprise, surprise (thank you Gomer Pyle USMC); the next series of Dr. D’s articles will be focused on complying with MHLW Ministerial Ordinance Number 169.
During the course of the last eight months, Dr. D has had the opportunity to dive into 98/79/EC, the European In-Vitro Diagnostic Medical Device Directive while extracting salient elements in the hope of providing Devine Guidance for the readers. This journey has now come to an end.
Dr. D has just one takeaway from this edition of DG; “Just comply baby!” It does not get any easier than that, well maybe not that easy.
The relationship between the notified body and the device manufacturer is not unlike a marriage. If a positive relationship is garnered and sustained, life is beautiful. If the relationship sours, then divorce is inevitable; and then the phrase is; “I want my CE mark back, now!”
This week’s guidance for IVDD Annex VII reiterates a device manufacturer’s commitment to supplying a device capable of providing accurate and repeatable results and ongoing compliance with the Directive.
Two takeaways this week are immensely important for device manufacturers: 1. Make sure maximum effort is exuded during the documenting and validation of the manufacturing processes, and 2. Manufacturers must take an active part in determining appropriate sample sizes for verification testing; do not let notified bodies make this decision without your input.
Article 16, of the Medical Device Directive delineates the requirements for “Notified Bodies.” The notified body is authorized to issue certification, and can take away the certification; the CE Mark of registration belongs to the notified body; if a certificate is withdrawn, manufacturers must remove the CE Mark of conformity; and Competent Authorities can suspend or revoke a certificate if the devices are found to be unsafe or ineffective.
Article 15 provides guidelines for device manufacturers that have product or are planning to introduce product, into an EU Member State, for the purpose of conducting a clinical investigation. Failure to comply with this will result in device manufacturers failing to obtain approval to pursue clinical investigations within the EU, and in today’s increasingly complex medical device market, not performing a clinical investigation will result in device manufacturers being shut out of the European market.
Article 14b, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Particular Health Monitoring Measures.” There are two takeaways from this edition of DG: One, a robust design and development process will lead to medical devices that are safe and effective; and two, devices that are safe and effective and meet their essential requirements seldom, if ever, will run afoul of Article 14b of the MDD.
Article 14a, of Council Directive 93/42/EEC delineates the requirements for “European Databank.” This week’s edition of Devine Guidance relates to the European Union (EU) and their need to develop a standardized format for data collection associated with medical devices; and a receptacle for collecting voluminous amounts of data. The takeaway for device manufacturers is that the EU continues with their pursuit of standardization in supporting the establishment of effective data management, with the devel…