MT Promedt Consulting GmbH is a Germany-based regulatory consultancy providing analytical and strategic services to the international health care industry (Medical Devices, In-vitro Diagnostics, Pharmaceuticals and Biotechnology). From product development to marketing, we provide 'hands-on' assistance in order to gain fast implementation of applicable legal requirements and to attain CE certification and international approvals in a cost effective manner and within a clear period of time.
The services routinely provided, include:
- International Product Registrations
- Establishing Quality Management Systems according to EN ISO 13485, cGMP
- Product Safety Testing Strategies
- Clinical Trial Services/Acting as the Legal Representative
- Expert Reporting for Extractables/Leachables and Biocompatibility
- Preparation/Update of Technical Documentations, Risk Management and Usability Files
- Clinical Evaluation, Follow-Up Reports/Post Market Surveillance Reports
- Acting as the European Authorized Representative
To our valued customers
In the following you can find a summary of important new information, regulations and new requirements for medical device manufacturers as well for in vitro diagnostic manufacturers in the last months, sorted by region and date:
Global Harmonisation Task Force (GHTF)
GHTF finalizes QMS guidance on corrective/preventive actions
The Global Harmonization Task Force has issued guidance on ways to measure, analyze and carry out improvements within medical device manufacturer quality management systems in relation to corrective action for non-conformities or preventive action for potential non-conformities of systems, processes or products (1).
The guideline makes it clear that the manufacturer is responsible for the implementation and maintenance of a QMS, which would enable the company to provide safe and effective medical devices meeting customer and regulatory requirements.
1. GHTF, Quality management system –Medical Devices – Guidance on corrective action and preventive action and related QMS processes (GHTF/SG3/N18:2010), Posted online 19 November 2010: www.ghtf.org/documents/sg3/sg3_n18.pdf
International Standard on GCP
Revised ISO standard on GCP for medtech trials ushers major changes
The much-awaited, revised international standard on good clinical practice requirements for medtech clinical investigations has been published by the International Organization for Standardization (1). The standard, ISO 14155:2011 (Clinical investigation of medical devices for human subjects - Good clinical practice), replaces two earlier versions of the document, namely: ISO 14155-1:2003 (Clinical investigation of medical devices for human subjects - Part 1: General requirements); and ISO 14155-2:2003 (Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans). Compared to the 2003 version, the revised standard contains some major changes, especially with regard to the definitions of safety and device deficiencies.
1. ISO 14155:2011, Clinical investigation of medical devices for human subjects - Good clinical practice, published 1 February 2011: www.iso.org/iso/catalogue_detail.htm?csnumber=45557
2. WMDO, Webinar on "The Hidden Challenges of the New ISO 14155 Requirements, 2 February 2011, www.wmdo.org/downloads/index.php?option=com_rsform&formId=9&Itemid=99999
Japan & Switzerland to exchange regulatory information
Japan’s Pharmaceuticals and Medical Devices Agency and its Pharmaceuticals and Food Safety Bureau have signed a “statement of intent” to share confidential data on medical devices and pharmaceuticals with Switzerland’s regulatory authority, Swissmedic (1,2).
This will allow Swissmedic and the Japanese regulators to exchange information on subjects including medical device recalls, quality defects and clinical trials. The aim is to identify risks at an early stage, enabling the authorities to take rapid action.
The Swissmedic has already concluded similar co-operation agreements with the authorities in New Zealand, Singapore, Canada and Australia, and the US. Japan has already confidentiality agreements in place with the UK, Singapore, the EU, Canada and the US.
1. Confidentiality Arrangement Statement, signed 7 November 2010 (posted on 26 November 2010): www.pmda.go.jp/english/international/pdf/arrangements/swissmedic-japan.pdf
2. Swissmedic press release, 8 November 2010:
EU issues new MEDDEV guides on clinical investigations and SAE reporting
The European Commission has issued two much-awaited MEDDEV guidelines – one on clinical investigations and the other on the reporting of serious adverse events that take place during clinical investigations (1).
The commission's guidance explains when a clinical investigation should be undertaken for a medical device to demonstrate compliance with the relevant essential requirements and the general principles of clinical investigations involving medical devices.
The commission's second guideline defines SAE reporting modalities and includes a summary tabulation reporting format5. The guideline covers all pre-market clinical investigations conducted with non-CE marked devices and CE-marked devices used outside their intended use.
The guideline only applies to pre-market clinical investigations that started prior to 21 March 2010 (when the new requirements came into place) and continued after that date. The implementation of Directive 2007/47/EC is not retrospective to SAEs that occurred prior to the 21 March deadline.
1. Guidelines on Clinical Investigation: A Guide for Manufacturers and Notified Bodies, MEDDEV 2.7/4, 13 December 2010: http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_7_4_en.pdf
2. Clinical Investigations: Serious Adverse Event Reporting Under Directives 90/385/EEC and 93/42/EEC, MEDDEV 2.7/3, 13 December 2010:
3. SAE Reporting form, 13 December 2010:
4. Eucomed NewsHub, CIE Working Group finalizes proposal for Guidance on Reporting SAEs during Clinical Studies, November 2010: http://whatsnew.eucomed.org/2010/11/cie-working/
EU borderline products manual updated to clarify classification issues
The European Commission has updated its borderline products manual to reflect its position on the classification of two new products: non-corrective contact lenses with a medical purpose; and pre-transfusion confirmatory tests1.
The manual, which reflects case-by-case opinions of the commission's working group on borderline products and classification, was last updated in July 2010. Borderline products in the medical device area are those for which it is not clear from the outset whether they should be classified as medical devices of one type or another.
1. European Commission, Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, Version 1.8: http://ec.europa.eu/consumers/sectors/medical-devices/files/wg_minutes_member_lists/version1_8_borderline_en.pdf
New EU standard ISO/IEC 62366 referring to Usability of Medical Devices must be followed by manufacturers
The standard ISO/IEC 62366 referring to the Usability of Medical Devices has been harmonized and is in force since March 2010 already. ISO/IEC 62366 is a process-based standard that requires from manufacturers to adopt a user centred design process that spans the design and development life cycle of the device. To comply, manufacturers must implement a usability management process. This process should be documented in detail in a Usability File which will be checked and controlled by Notified Bodies. We will provide more information on the implementation of this standard in a separate special newsletter.
1. ISO/IEC 62366:2007. Medical devices - Application of usability engineering to medical devices.
Canada finalizes guide on interpretation of significant changes to medical device
Health Canada has finalized changes to its guidance on the interpretation of significant changes to medium- and high-risk medical devices (Class III and IV) to help manufacturers decide whether the proposed changes require the submission of a license amendment application prior to introducing the device on the market (1). The finalized document comes into effect on 1 April and will replace the existing guidance on the topic (2), which has been in place since March 2003. Major changes include updated examples of "significant changes" and a restructuring of the guidance for additional clarity.
1. Health Canada, Consultation on Draft Guidance Document, 13 October:
2. Health Canada, Draft Guidance Document - Preparation of the Summary Technical Documentation (STED)-based Class III and Class IV Premarket Medical Device Licence Applications, 13 October 2010:
US FDA clears first diagnostic imaging review app for iPads and iPhones
The US Food and Drug Administration has cleared for the first time a mobile diagnostic imaging review application for use on the iPad and iPhone manufactured by Apple (1).
The Mobile MIM application, which is made by Cleveland, Ohio-based MIM Software, was cleared under the agency's 510(k) regulatory process for viewing, and making medical diagnoses based on, images from CT, MRI and nuclear medicine technologies, including PET. The Mobile MIM application is already CE marked and available in Europe, Asia-Pacific, the Middle East, and some Latin American and Caribbean countries (2).
1. FDA press release, 4 February 2011:
2. MIM Software, accessed 7 February 2011: www.mimsoftware.com/products/iphone
Australia explains process for application audits of IVD submissions
Australia's Therapeutic Goods Administration has issued a detailed note explaining which in vitro diagnostic applications for inclusion in the Australian Register of Therapeutic Goods are subject to application audits on a mandatory and random basis, and what this process involves (1).
Where the regulation requires a mandatory application audit of an IVD submission, the TGA will charge an assessment fee. If the fee is not paid within the specified time frame the sponsor will need to reapply to include the IVD in the ARTG and pay any fee associated with a new application.
1. TGA, Application audit (technical file review) of IVD medical device applications, 14 February 2011: