By: Ludger Möller

News and Views

January 2010

Content

Overall review of the recent market surveillance
MDSS website caution statement
Updated Guidelines
1. MEDDEV for Vigilance
2. MEDDEV for Clinical evaluation
3. MEDDEV for Borderline products
Comments

Dear valued Client

The team of MDSS wishes all our clients and all other readers of the news and views a Great New Year.

MDSS again is planning various occasions to be personally accessible for its clients. Please check the MDSS website (www.mdss.com) for any details. The next opportunity to meet MDSS is the MD&M in Anaheim US from February 9 to February

Overall review of the recent market surveillance

The end of 2009, as we see it, was the turning point of the European regulatory environment. It seems that the authorities are waking up. We noted the following:

• Reviews of a certain type of products industry wide all over Europe (review of actual product samples, labeling and technical files).
• Feedback during the initial notification of products (review of risk classification but also a limited technical file review)
• Additional registration in other countries bestowed upon the manufacturer (see Italy)
• Stricter review of incident notification in certain countries (requests for risk and root cause analysis)
• Stricter review of Field Safety Corrective Action (details requested country by country)

The overall issue we noted with the increased surveillance is that the concept of the “relevant” or “leading Competent Authority” (CA) are not applied and as it seems there are no efforts to harmonize the surveillance.

MDSS website caution statement:

The increase in market surveillance fits nicely with the update of the directive. In an earlier issue of the News and Views we made you aware of the rapid updates that occur in regards to MDD related documents e.g. MEDDEV documents. Information and guidance provided is based on the official publication of the European Union and therefore it is the nature to provide only subsequently the information. Due to the importance of the changes please always refer to the official European Commission website for the latest information (http://ec.europa.eu/enterprise/sectors/medical-devices/index_en.htm) and contact MDSS for any guidance directly.

Update Guidelines

The guidelines need to be adjusted to reflect the new directives. A lot of changes will occur now. Please check back with the Commission website on a regular basis (http://ec.europa.eu/enterprise/sectors/medical-devices/documents/guidelines/index_en.htm) where you will find the guidelines.

1. MEDDEV for Vigilance:

The Guideline on a medical devices vigilance system was updated to revision 6 (MDDEV 2.12-1 rev 6 December 2009). (http://ec.europa.eu/enterprise/sectors/medical-devices/files/meddev/2_12_1-rev_6-12-2009_en.pdf). Only the incident report form was changed. The main changes are:

• Does the incident represent a serious public health threat?
• Implant and Explant dates for implanted medical devices or
• Alternatively the implantation duration
• Number of similar incidents.

The form is provided as a word document and can be found on the European Commission website under section 2.12 Market surveillance, "Manufacturer Incident Report": http://ec.europa.eu/enterprise/sectors/medical-devices/documents/guidelines/index_en.htm

MDSS will only use this form. Please update your procedures to change the reference even though this aspect may not be related to your product. It certainly will show that your quality system is able to adjust quickly to those aspects, which is important for the Notified Body during the quality system review.

2. MEDDEV for Clinical investigation, clinical evaluation

The guideline clinical evaluation was significantly updated with its latest revision (MDDEV 2.7.1 Rev.3, December 2009). (http://ec.europa.eu/enterprise/sectors/medical-devices/files/meddev/2_7_1rev_3_en.pdf). In Annex F it provides a checklist. We strongly recommend filling out the checklist for two reasons:
1. Most certainly to check the compliance whether all aspects of the clinical evaluation have been taken into consideration and
2. For the notified body to make the review easier for them and to save their resources since it may become costly if the Notified Body feels obligated to utilize this checklist during the technical file review.

3. MEDDEV for Borderline products

The guideline borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative (MDDEV 2.1/3 rev 3) was updated. (http://ec.europa.eu/enterprise/sectors/medical-devices/files/meddev/2_1_3_rev_3-12_2009_en.pdf). This update was in particular needed due to the update of the directive.

Comment:

We strongly recommend controlling the guidelines with your quality system under external documents. Keep in mind that the guideline are not laws but in most cases provide a good interpretation of the regulation. Another aspect, which should be kept in mind, is that there may be national differences to the guideline recommendation which must be taken in to consideration in case those differences are implemented with the national laws.

We hope that the regulatory updates will not disrupt your business and wish you a successful 2010.

Best regards,

Ludger Möller
President

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