Newsletter No 14 May 2020

Subject: Timeframes for announcements – how is the current situation?
Introduction:
When the news was released that the MDR was postponed by the European Union, it meant for most companies that they would have more time to improve or better update their processes. But does postponement of MDR mean that the processes given by the MDD and the national laws are still in service? We received some questions from colleagues working in special departments about the current situation for the timeframes for announcements of incidents.

Current Situation in European Countries:
MDD
The situation in some European Countries needs a closer look. Before the MDR was released, the MDD defined the requirements. Article 10 defines only possible reasons for an incident:
(a) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(b) any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in subparagraph (a), leading to systematic recall of devices of the same type by the manufacturer.

The detailed information about timeframes was left to the local national laws which should define the timeframes for a possible announcement more precisely. But now the problem arises, how to manage if a product is registered in more than one European Country. What should be done and what actions should be taken if a product is registered in different countries with different timeframes. These differences were a significant challenge to every person working with safety topics.

So, for some countries, including Germany, most of the incidents had to be announced within 30 days after becoming aware of the problem. But this does not mean, that we have to expect the same timeframe in Switzerland or in the UK. Furthermore, adding to this confusion was that every national authority provided their own timeframe within the announcement form. When opening and downloading the form the national timeframes are provided in the form itself.
So far so good, but if an incident would need an extremely detailed examination (e.g. a class III cardiac stimulator) in some countries the given timeframe was often insufficient. As a possible solution sometimes, semi-finished reports were provided to meet the timeframe and the complete examination report was sent later. The acceptance of this falls under the national authorities.

A longer timeframe has the advantage that an entire investigation could be performed in more detail. This long timeframe also contains the hazard of stalling and endangering more patients and users. The second disadvantage is the imprecise definition of the reasons for an incident. So there was a need for more precise and detailed definitions. Often death of a patient was used to trigger an announcement (MDD Article 10: might have led to the death of a patient or user or to a serious deterioration in his state of health), but this often may not cover medical devices of Class I and IIa sometimes also Class IIb. The wording: serious deterioration in his state of health was also not helpful. Is a less allergic reaction caused by Nickel and Chromium in brackets a deterioration in his state of health?

MDR
When the MDR was released it contained a more precise definition of an incident.
So article 2 (Definitions) gives us the following definitions referring to incidents.
(57) ‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device;

(58) serious adverse event’ means any adverse event that led to any of the following:
(a) death,
(b) serious deterioration in the health of the subject, that resulted in any of the following:

• (i) life-threatening illness or injury,
• (ii) permanent impairment of a body structure or a body function,
• (iii) hospitalisation or prolongation of patient hospitalisation,
• (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
• (v) chronic disease,

(c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect;

(64) incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect;

(65) serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following:
(a) the death of a patient, user or other person,
(b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health,
(c) a serious public health threat;

(66) ‘serious public health threat’ means an event which could result in imminent risk of death, serious deterioration in a person’s state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time;

Please take a very close look to the wording and find that not the incident itself is a reason for an announcement but also the possibility that such serious adverse event may have occurred. This will cause a twilight zone of wild guesses of what had been if………? Our example with the less allergic reaction caused by Nickel and Chromium in brackets is still unclear because we need to ask if someone could avoid this allergic reaction by using a much more expensive material? As a rationale of this definition in cases of incidents and announcement please imagine a worst case scenario to cover this.

Timeframe
Let´s take a look on the timeframes given by the MDR. They are now extreme short and related to the whole European Union instead of only one country. So the MDR covers the problem of national timeframes. The Article 87 defines the timeframes for incidents:

3. Manufacturers shall report any serious incident as referred to in point (a) of paragraph 1 immediately after they have established the causal relationship between that incident and their device or that such causal relationship is reasonably possible and not later than 15 days after they become aware of the incident.

4. Notwithstanding paragraph 3, in the event of a serious public health threat the report referred to in paragraph 1 shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of that threat.

5. Notwithstanding paragraph 3, in the event of death or an unanticipated serious deterioration in a person’s state of health the report shall be provided immediately after the manufacturer has established or as soon as it suspects a causal relationship between the device and the serious incident but not later than 10 days after the date on which the manufacturer becomes aware of the serious incident.

Timeframes like this make it hard to provide a serious investigation to the national authorities. Any announcement will carry the risk of false incident sent to the national authorities due to the extreme lack of time. In such a case please check as best as possible. If we compare the requirements of the MDR with the requirements of a referring national law we´ll find the following differences:

As a conclusion, reviewing this table we see that national laws may defines timeframes which are wider or more imprecise than the MDR. Considering that the MDR is in force since 2017 and “overruling” any national laws the timeframes of the MDR are valid. The MDR requires the European Countries to provide additional laws, but the status is not clear today. E.g. German national laws are still valid, but the MDR prevails on the German national laws. This situation is the same in all European Countries nowadays. So any announcement of an incident should follow the MDR timeframes and definitions. In case some national laws offers a shorter or better defined timeframe this needs to be discussed after the release of the law.

Transition period between MDD and MDR
As you see, the transition period between MDD and MDR contains a lot of uncertainties especially in the regulatory parts. STS group takes the requirements of the MDR very seriously and tries to shed some light into the twilight zone of interpretation. This was done by a full transparency policy and a successful cooperation with National Authorities and Notified Body.

This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”.
We are already today all dependent on an effective cooperation. For the MDR implementation, we require even a closer collaboration in order to ensure we all can deliver safe supply to hospitals and patients in the future. We are confident we will be able to continue to supply health care competently on customized surgical procedure sets and small kits.
The next MDR Newsletter will be issued in June.

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