Newsletter March 2015
We are happy to share with you the latest news: MEDCERT has successfully accomplished his re-accreditation. Therewith, after over 20 years on the market, we still remain Notified Body for the Directive 90/385/EEC and the Directive 93/42/EEC and Certification Body for ISO 13485.
On this occasion we would like to say “thank you” to the whole MEDCERT-Team for the exceptional performance. Congratulations to us all!
We are pleased to announce that MEDCERT opened its new subsidiary in Boston, US!
MEDCERT, as a Notified Body, has been successfully active in the market for over 20 years. After opening the branches in China and Malaysia, we are happy to continue our expansion and strengthen our presence also in the American market. Thanks to the own local staff we will be able to respond quickly to the needs of our American customers.
In charge of our subsidiary in the US is Ms Tina Lochner. Ms Lochner is a seasoned auditor and product expert with more than 10 years of experience with Notified Bodies primarily in North and South America and many years in the medical, biotechnology and pharmaceutical industry.
Currently we are building up our team and looking for a qualified support – if you are interested in working for MEDCERT LLC as an external auditor, we would be happy to hear from you.
Please find below the contact details of Ms Lochner:
1st Floor WeWork Fort Point
51 Melcher Street
Boston, MA 02210
Mobile: +1 202 674 7239
We look forward to your inquires!
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 EMERGO Survey among Medical Device Industry was conducted in December 2014 to January 2015. In the survey participated over 5,400 respondents. The survey gives an industry outlook for 2015 and, among others, presents opinions about the challenges on the regulatory approval processes and markets.
For the results of the survey please go to: Outlook for the medical device industry in 2015.
The NBOG- Notified Bodies Operations Group has published two new guidelines:
“Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System” and “Renewal of EC Design-Examination and Type-Examination Certificates: Conformity assessment procedures and general rules”.
You can find the guidelines under:
- Renewal of EC Design-Examination and Type-Examination Certificates: Conformity assessment procedures and general rules
- Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System
The Netherlands government compered the market authorization procedures of the USA and Europe and came to the conclusion, that the basic concept of the legislation is similar.
In both systems, the effort to obtain market authorization increases with the perceived risk of a device. The market authorization can be easier claimed for those devices, for which the equivalence to an existing device can be claimed. Furthermore, in both systems, the market access of lowest risk class devices is in the responsibility of the manufacturer.
Even if there are some differences between both systems, it cannot be stated, that one system will lead to a different level of quality and safety than the other.
The complete comparison (in English) is available under: Comparison of market authorization systems of medical devices in USA and Europe.
The China Food and Drug Administration has issued two important documents. The first document is a revised good manufacturing practice (GMP) guideline, which will apply from March 1, 2015. The second document is a complete new guideline on good supply practice (GSP). The GSP rules have been in effect since December 2014.
The new requirements are an important part of China’s regulatory framework for medical devices. They are intended to strengthen the supervision and management of medical device manufacturing and distribution, standardize quality management and distribution behaviors, and further ensure the safety and effectiveness of medical devices.
- CFDA announcement: CFDA issues Good Manufacturing Practice for Medical Devices
- CFDA announcement: CFDA issues Good Supply Practice for Medical Devices
Three out of the five medical device notified bodies in Switzerland have either closed down or plan to do so by the middle of this year. This is a result of more stringent requirements for the monitoring of the Notified bodies, started in 2013 as part of measures to improve device safety adopted by the European Commission after the Poly Implant Prothése (PIP) breast implant affair. The intensified market surveillance has resulted in certain Notified Bodies in Switzerland and Europe deciding to discontinue their medical device certification activities.
In this case also the medical device certificates lose their validity, when the designation of the Notified Body expires. This have big implications for manufacturers.
Swissmedic explains that if a notified body decides to discontinue working, then it has to inform its customers about this and also define an appropriate transitional period and follow-up solutions. Nevertheless, the primary responsibility for ensuring that a medical device conforms to the relevant national and international laws rests with the manufacturer. Companies affected by closing down of notified bodies can approach any other notified body, provided the notified body is designated for the process and product category in question. A list of all Notified Bodies entitled to issue EC certificates in the medical device sector are listed in the EC’s NANDO database with their scope.
More information under:
- Swissmedic Announcement – Intensified surveillance of medical devices – supplementary information
- NANDO database
The Saudi Food and Drug Authority has issued new guidance on labelling of medical devices. The guidance applies to medical device manufacturers, authorized representatives, importers and distributors.
To obtain the Saudi MDMA – Medical Device Marketing Authorization, a device should comply with one of the following relevant regulatory requirements applicable in one or more of the jurisdictions of Australia, Canada, Japan, the USA and the EU/EFTA, and with provisions specific to Saudi Arabia, including those concerning labelling and conditions of supply and/or use. The SFDA reserves the right to request evidence when labelling includes a symbol/logo (eg CE Marking) used by another jurisdiction to indicate the device complies with the relevant regulations of that other jurisdiction.
Among others, the list clarifies that in cases where dual-language labeling is not available or possible for lay-use devices, labeling should be provided in Arabic and the labelling information must include the country of origin.
A full list of labeling requirements is available in the SFDA guidance document under: SFDA – Guidance on labelling requirements for medical devices.