Thanks for volunteering to take the "bull by the horns" on this one Dan. It is a huge mess, prompted by misunderstandings of personnel in device manufacturers, but worst of all by NB auditors. I would hope that the auditors are better trained by the Notified Bodies, but I guess I am overly optimistic!
Of course the problem started with the EU regulators failing their obligations on harmonizing standards, which was aggravated by the imposition of unrealistic deadlines of the new regulations, which were incomplete, along with the supporting mechanisms when released. So the blame can be shared. But this mess needs to be cleaned up. There is not enough time in my estimation, if the EU markets are not to be impacted by these unfortunate decisions.
Keep up the good work in your efforts on the EU Regulations, your postings have been very thoughtful and most helpful!
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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com------------------------------
Original Message:
Sent: 03-Feb-2021 18:00
From: Dan O'Leary
Subject: Standards applied - harmonised version or latest version?
This topic is a recurring event and is, I suspect, the most frequently occurring device topic.
I write, because the question mystifies me. I intend to offer my thoughts in simple terms, mostly avoiding technical issues.
The overarching issue for medical device manufacturers to make the "best" devices possible. Here "best" means safe, effective, etc.
The overarching issue for medical device regulators is to ensure the manufacturers make the "best" devices possible. The whole reason, in the EU, for the shift from the directives to the regulations is to help ensure the "best" devices possible. The EU view is that the directives didn't provide the necessary requirements and that the regulations provide the necessary structure.
Device manufacturers typically rely on standards to help assure the "best" approach. Current standards provide the necessary information to implement the "best" approach.
The EU set up a system to help protect device manufacturers, the harmonized standards. In this system, the harmonized standards are voluntary, but if implemented provide a "presumption of conformity" that includes legal protection for the manufacturer.
There is an implicit assumption that the harmonization process would keep up with the current standards so, perhaps with some minor lag, the current standards and the harmonized standards align. In addition, the harmonization process includes a phase-out period for older standards.
So far so good. Harmonized standards align with current practice, devices are "best", manufacturers have legal protection, and older versions of standards fade away.
There are, unfortunately, (at least) two problems.
First, the harmonization process has failed. Many standards harmonized to the MDD, AIMD, or IVDD have been obsolete for years. In practice, this is not a problem, because using harmonized standards is voluntary. A device manufacturer should move to the current standard.
Second, there are Notified Bodies, that seem to require manufacturers to use only harmonized standards, not current standards. Cast in a different view, these NBs require that the devices are NOT the "best", but must lag behind.
Forever the optimist, I don't believe that there is an NB under either the directives or the regulations that has an official position that requires the use of only harmonized standards. However, I expect that individual auditors write invalid nonconformances in this area. A valid nonconformance states both the requirement and how the auditee failed to meet. Since there is no requirement to use a harmonized standard, there could not be a valid nonconformance.
I suggest two actions.
First, RAPS should collect and publish each NBs policy statement on the use of harmonized standards for the three directives and the two regulations.
Second, collect, unofficially, cases in which an auditor wrote a nonconformance outside the NBs policy for the use of a harmonized standard.
For the second action, please send me, through RAPS, the statement of the nonconformance and the name of the NB. I would like the full statement of the nonconformance. I'll collect them, summarize them, and provide reports. A report will not include the company name, auditor's identity, or similar identification. It would identify the NB.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 01-Feb-2021 17:23
From: Anonymous Member
Subject: Standards applied - harmonised version or latest version?
This message was posted by a user wishing to remain anonymous
Hi All,
In regards to the list of standards applicable to a particular type of medical devices, it is not unusual that the harmonised version is far earlier than the latest version. For instance, as per Commission Implementing Decision (EU) 2020/437 of 24 March 2020, BS EN ISO 11607-1:2009 is harmonised however in BSI shop the current version is shown as BS EN ISO 11607-1:2020.
I understand that the manufacturer may prefer to use and quote the latest/current version of standards in their technical documentation to: (1) demonstrate their commitment to conform to the highest level of requirements; and (2) minimise the risk of having to carry out additional work when the new version becomes harmonised at a later date (especially if they are considering all the new requirements as part of a bigger project). However, in reality, it is the harmonised version that demonstrates conformity to EU legislation, e.g. MDD, IVDD etc. The manufacturer may be questioned by their notified body why they've not used the harmonised version instead.
I am wondering what are the experts' views on this, and what's the common practice in the industry please?
Many thanks in advance.