Newsletter November 2014
Since publishing of the Commission Recommendation 2013/473/EU on audits and assessments performed by Notified Bodies, the questions on its legal basis have been raised. Are Notified Bodies, and consequently certified manufacturers of medical devices, bound by this Recommendation? German Attorney, Dr. Volker Lücker is trying to find answers to these questions.
In his article, Dr. Volker Lücker questions the nature of recommendations in general, before examining the nature of this specific Recommendation (2013/473/EU) and then considers the consequences for any rights and obligations of Notified Bodies, taking Germany as an example.
To get the full text click here.
The world largest medical devices trade show takes place from 12 to 15 November 2014 in Düsseldorf, Germany.
You are welcome to visit us in hall 5 booth no. 5D02 (the same as last years).
Experts and lead auditors are available to discuss with you all your matters regarding certification and CE marking.
The European Commission has published an update to the “Manual on Borderline and Classification in the Communication in the Community Regulatory Framework for Medical Devices” (version 1.16).
The updated manual includes a new section on software and mobile applications reflecting the growing industry of medical device software. The manual also provides new guidance on the classification of two distinct borderline medical device-medicinal products, namely, a riboflavin solution for the treatment of keratoconus and dentistry products with aluminium chloride used in haemostasis.
The manual is intended to serve as a tool for device classification in cases that are unclear or for products that are excluded by the scope of the Directives, and provides examples of products or categories that have raised doubts.
The views expressed in the manual are not legally binding, but can greatly assist the task of device classification.
More information under: Manual on Borderline and Classification in the Communication in the Community Regulatory Framework for Medical Devices (version 1.16).
Australia’s Therapeutic Goods Administration has signaled its distrust of eight European medical device notified bodies whose business practices were questioned in a 2012 investigative study in the BMJ on the failings of the EU notified body system. The TGA is to audit all medical devices in Australia that are supported by conformity assessment reports from these eight notified bodies. The TGA explains that it wants to obtain its own evidence of the quality of certificates and reports issued. While Australia and EU medtech authorities have a mutual recognition agreement (MRA) in place, the TGA explains that it is conducting its own audits following the consideration of the BMJ article and consultation with “other regulators”.
More information under: TGA-Website: Increased application audit requirements for some medical devices applications.
You can find the BMJ article here.
The U.S. Food and Drug Administration (FDA) issued a draft guidance titled “Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements.” FDA has identified certain class I and II devices for which risks, safety and effectiveness have been established well enough for the agency to deem premarket notification as being no longer necessary.
The draft guidance lists over 100 product codes and devices that FDA proposes to exempt from 510(k) requirements.
The agency maintains that exemption from 510(k) requirements does not mean that these devices will bypass all controls; these products will continue to be subject to other statutory and regulatory requirements, including registration and listing, labeling, good manufacturing practice requirements as set forth in the quality system regulation and medical device reporting requirements.
More under:
- Publication in the Federal Register
- FDA Draft Gudiance – Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements.
Ukraine’s new system of conformity assessment for medical devices is going to come into effect in the third quarter of 2015. This is three months later than the date signalled in summer 2014, which was already a year behind the original-planned entry-in-force date of July 2014.
The new conformity assessment system includes new technical regulations related to medical devices, IVDs and active implantables. The devices whose certificates of approval would expire before the new system takes effect may still be put in circulation (post-certificate expiry) until the end of their shelf life. This is provided they were manufactured and were already being put into use during the period of their registration.
MEDCERT was informed about a fake MEDCERT-certificate, which circulates on the market. Please note that this certificate was not issued by MEDCERT and is not valid or legally binding.
The fake certificate can be viewed here:
