Medical Newsletter
TÜV Product Service Medical Testing Times : July 2008
This is the second edition of the 2008 ‘Medical Testing Times’ from TÜV Product Service. This newsletter is designed to keep you informed about changes within the industry – updates to requirements, new services we offer, events we are exhibiting at and other relevant news. For more information on any of the stories please email us at: info@tuvps.co.uk
TÜV Product Service recruits a new Medical Device Auditor
Etienne Lombard joined the Medical and Health Services team at the beginning of June with 26 years experience in the medical device and pharmaceutical industry including 24 years with Baxter Healthcare. Etienne has degrees in both chemistry and in management and has worked in various roles including in a Laboratory, Regulatory Affairs, Quality Assurance and in Senior Management.
Etienne is currently undergoing the comprehensive TÜV training programme and will take on the responsibility of a Lead Notified Body Auditor for some of our customers manufacturing plastic, liquid and pharmaceutical like devices.
Reminder on changes to ISO 13485; EN46003 withdrawn; de-coupled from ISO9001
In February 2008 the standard EN ISO 13485:2003 was replaced by the standard EN ISO 13485: 2003 / AC: 2007. The core requirements within ISO 13485: 2003 remain unchanged, but presumption of conformity with the various annexes within the Medical Devices Directive (MDD) have changed. The ISO 13485 standard allows certain clauses to be excluded even if these are applicable to a company so long as the regulatory conformity assessment routes within the MDD allow this. The most common example of this is for companies manufacturing class 2a devices to exclude design and follow annex V of the directive rather than annex II. The standard EN 46003 was not withdrawn when EN 46001 and EN 46002 were replaced, but this is now going to be withdrawn and replaced by the new EN ISO 13485: 2003 / AC: 2007. The following shows the application and exclusions of the new standard. Please note that module E (replacing EN 46003) only allows three subclauses of the standard to be excluded.
Application:
- EN ISO 13485: 2003 / AC: 2007 replaces the standards EN 46003:1999, EN ISO 13485:2000 and EN ISO 13488:2000
- The new standard can be used for the implementation of quality management systems based on modules D, E and H (as defined in 93/465/EEC):
o Module D is the basis for
§ Annex V of 93/42/EEC
§ Annex 5 of 90/385/EEC, and
- Annex VII of 98/79/EC.
o Module E is the basis for
- Annex VI of 93/42/EEC
o Module H is the basis for
§ Annex II of 93/42/EEC,
§ Annex 2 of 90/385/EEC, and
- Annex IV of 98/78/EC
Exclusions:
· The following exclusions are allowed:
o Module D: Subclause 7.3 of EN ISO 13485
o Module E: Subclauses 7.3, 7.5.1 and 7.5.2 of EN ISO 13485
o Module H: no exclusions
IEC EN 60601-1 3rd Edition
After nearly 20 years feeling comfortable with the second edition of 60601-1, our peace has been shaken by the publication of the 3rd edition in 2005/6.
At the time of writing, this standard has not been harmonised by being cited in the Official Journal, but this is expected soon, and at the same time we expect the transition time to be clarified. Our advice to industry is to start working on compliance to the new standard now. The first country to accept the 3rd edition was Canada and their transition time ends in December of this year from which time the 3rd edition will be mandatory.
Much has changed since 1988. We shall have to get used to a new clause numbering system and layout, to a raised profile of risk management, new leakage current concepts, more specific electrical component and mechanical requirements, plus much more.
There are still some familiar bits, at least the colours of indicator lamps have not changed!
As is the long-standing policy of the IEC, the standard is supported and explained by a comprehensive Guidance and Rationale section of over a hundred pages.
Certain collateral standards (the 60601-1-x range) have been incorporated into Part 1, Programmable Electrical Medical Systems (previously 60601-1-4) with greater reliance on Risk Management to ISO 14971 and Medical Electrical Systems (previously 60601-1-1). EMC requirements remain in the collateral standard (60601-1-2), but discretion as to whether or not they shall be applied depends on a risk management approach (60601-1 3rd edition clause 17). Time and experience will tell how satisfactory this approach is and how appropriate from a regulatory standpoint.
TÜV Product Service is able to help manufacturers with 3rd edition queries and will post updates on the harmonisation process and transition arrangements as soon as the position becomes known.
Changes to EN 980
The EN980 standard “Symbols for use in the labelling of medical devices” was revised in July 2008. The advantage for manufacturers in using symbols is that it reduces the length of multi-lingual instructions for use and labelling.
The biggest change is that Clause 5 (Symbols in Use) has been greatly expanded to include a total of 29 symbols, up from 12 previously. These 29 symbols can now be used "without explanation in the information supplied by the manufacturer." This means too that they do not need translation.
A topic of much discussion in recent years has been re-sterilization – can be or can’t, should or shouldn’t. There is now a clear symbol indicating Do Not Re-sterilize.
There is still an overlap in the meanings of a triangle containing an exclamation mark (caution, consult instructions for use) and an open book with the letter “i” on the right hand page (consult instructions for use). This overlap is acknowledged in the new standard.
Symbols that were previously in Clause 6 and needing explanation and translation (if required) have been moved to Clause 5 and can now be used without them.
There are three new symbols in Clause 6:
6.2 Contains or Presence of Natural Rubber Latex;
6.3 Do not use if package is damaged, and
6.4 Sterile fluid path.
These need explanation in the accompanying information and translation if required.
Annex A gives useful examples of how the symbols could look in a typical application.
Annex B (which is informative and not normative) needs to be read carefully as it contains guidance on negative and prohibition symbols. (Do not..., does not contain..., is not....). The main point is that it is not recommended to place diagonal lines or Xs over symbols which appear in this standard (unless they already have them). In other words, use the given symbols as shown and without modification.Successful Open Day at Head Office in Fareham
At this year’s Open Day at Octagon House on the 4th June, guests were able to tour our state of the art testing facilities and listen to many different presentations on relevant technical topics, while at the same time enjoying a boat trip and buffet lunch around the Solent. This year the seas were calm and the Princess Caroline set sail from Southampton and over to the Isle of Wight. We had a very successful day and it was enjoyed by all who attended.
Upcoming Events
Norman Richardson will be speaking on “Changing Conformity Assessment Requirements for the MDD” on the first day of the Medtec Ireland conference (24-25 September) in Galway. See link below for further details: http://www.devicelink.com/expo/medtire08/
Past Events
Henry Sibun and Angus McLean attended the Medical Innovations Forum on the 25th June, chairing a round table discussion on Risk Management for Medical Device Manufacturers.
Henry Sibun chaired the first day and spoke at the Informa Life Sciences’ ‘Medical Device Summer School’, on 16th – 18th July in Cambridge.
Useful Links
Standards Harmonised against the Medical Devices Directive:
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html>
Guidance documents from the European Commission:
http://europa.eu.int/comm/enterprise/medical_devices/index_en.htm
