Medical  Device   &    QA  Consultancy / Services

GUIDANCE ON COMPLIANCE with the REVISED MEDICAL DEVICE DIRECTIVE

The changes can be summarised as follows;

Clinical Data in the form of a CER (Clinical Evaluation Report) required for all class of device.

Updated ERC (Essential Requirements Checklist) covering amongst other things, Usability

Risk Analysis results to be supplemented by Usability requirements.

Some devices have been reclassified into a higher category

These two Documents added 22nd JULY 2009:

 INTERTEK more detailed information on the changes

INTERTEK a form that will help us identify any change to the classification of your device

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Client’s Update – June 2009

1               EUROPEAN MEDICAL DEVICE DIRECTIVES

European Commission issues interpretation of Directive 2007/47/EC

The European Commission has issued an interpretative document (dated 5 June 2009) of Directive 2007/47/EC (which amends the Medical Devices Directive MDD 93/42/EEC and the Active Implantable Medical Devices Directive AIMDD 90/385/EEC). Download it here.

As you are probably aware, EU Directive 2007/47/EC modifies the Medical Devices and Active Implantable Medical Devices Directives, and must be applied starting 21 March 2010. The European Commission guidance indicates that on 21 March 2010 medical devices placed on the market at that time must comply with Directive 2007/47/EC. This clarifies a point that was not clear in Directive 2007/47/EC. (2007/47/EC does not amend the In Vitro Diagnostic Devices Directive IVDD 98/79/EC.) If you need a refresher on the changes made by 2007/47/EC to 93/42/EEC, read Emergo Group's brief overview. 

The newly published guidance document discusses five topics:

• Compliance of medical devices with the new requirements;
• Evaluation by Notified Bodies according to the new requirements;
• Certificates issued prior to 21 March 2010;
• Consultation of authorities responsible for pharmaceuticals; and,
• Overlap with the Machinery Directive.

After 21 March 2010, medical devices placed on the European market or put into service, must conform with the (new) requirements of the revised directives. This is applicable to each individual device. The terms “placing on the market” and “putting into service” are defined in the directives. Further, products already lawfully on the market or put into service prior to 21 March 2010 can continue to be marketed. (As an example, an ultrasound machine at a facility in The Netherlands placed there prior to 21 March 2010 can remain there.)

Compliance before 21 March 2010, is voluntary. However, if a manufacturer’s devices are compliant before that deadline, the Declaration of Conformity for the medical device should document the compliance with the Directive and include the text: “as amended by Directive 2007/47/EC.” And, if a Notified Body is involved in issuing the CE Marking for the medical device, the Notified Body must have verified compliance with Directive 2007/47/EC, before the Declaration of Conformity reflects compliance with Directive 2007/47/EC.

To reiterate, by 21 March 2010, manufacturers’ devices must be compliant with the modified Directive (Directive 2007/47/EC). Declarations of Conformity issued after 21 March 2010 are presumed to be compliant to the MDD and AIMDD as amended. And, any Notified Body assessments (renewal or delivery) which occur after 21 March 2010 must consider the (new) requirements of the revised directives. Medical devices whose classification was modified as a result of Directive 2007/47/EC (see changes to Annex IX, Classification Criteria MDD 93/42/EEC) must  have obtained a new certification if it is placed on the market or put into service after 21 March 2010.

Beginning on 21 March 2010, Notified Bodies can no longer issue unlimited CE marking certificates (MDD 93/42/EEC Annexes V and VI plus AIMDD 90/385/EEC Annex V) which will be limited to a maximum of five years. Also, prior to 21 March 2010, existing unlimited certificates need to be reissued with a limited validity that has considered Directive 2007/47/EC.

If your conformity assessment involved a Notified Body, we would strongly recommend that you discuss the status of your current CE marking certificates and the provisions of Directive 2007/47/EC and this document with your Notified Body. If there are questions about Directive 2007/47/EC or compliance of your devices with the directives, please consider contacting us!

2               FROM THE NOTIFIED BODY

This is typical of letters being sent out from Notified Bodies, this is from Intertek/AMTAC

Dear Valued Client

On this occasion, we are writing to advise you about a change that we are implementing concerning the time allocation for on-site audits and technical file reviews. The need for this change is brought about by the implementation of Medical Device Directive (Amendment Directive) 2007/47/EC which has an effectivity date of March 2010. The Amendment Directive introduces the requirement for thorough technical file review(s) to be included as part of the evaluation of conformity process. In order to reduce risk & to support our Client base to demonstrate compliance at the appropriate time we need to address the necessary changes now.

When determining the amount of on-site audit time we follow certain mandatory guidance and this is mostly influenced by the number of employees on site. Until now it was implied that a portion of this on-site time is allocated to the examination of technical files, however judgements from EU Competent Authorities which have lead to the amendment to the Medical Device Directive have determined that on a wide scale, the shared allocation of on-site management systems audit time will not meet the expectation & technical focus of the amended Directive. Amtac support that there is a greater added value to our Clients systems if the on-site time is spent auditing the organisation's processes in a practical way. This means seeing the processes in action and speaking to the personnel that perform them.

The advantage with going through a review early is that you will get feedback on whether you have addressed all of the new requirements and in an appropriate way.

In order to ensure that the appropriate level of technical file review activity is performed whilst at the same time maintaining the effectiveness of the on-site audits, we propose to carry out technical file reviews as an off-site activity. During each on-site visit the auditor will select existing files for review, using the same criteria that are currently applied (viz. highest risk class and amount of changes since the last audit). Arrangements will then be made for the files to be available to the auditor for review shortly after the audit has taken place. This will be a chargeable activity with an expected time requirement of four hours per file (minimum) and up to one day.

With the revised Medical Device Directive, we also need to determine if any special assessment activity is required and, if so, plan to have this activity completed before the March 2010 deadline.

3               RECAST OF THE MEDICAL DEVICE DIRECTIVE

At a recent Notified Body conference the opinions were put forward as to the reasons why a “recast” is necessary. Some of these were given as;

• Simplification of the current system, i.e. merge 2 directives.
• Improvements in the safety of medical devices.
• Improve harmonization, qualifications, consistency, transparency and responsibilities of Notified Bodies.
• Improve and make clinical investigations more consistent.
• Improve vigilance system and make it consistent across the EU.
• Integrate proposals from the Global Harmonization Task Force.
• General reinforcement of the regulations and creation of a legal framework

Timing suggested is;

• Reflection on issues and policies;    2009
• Impact assessment    2010
• Prepare legal draft,      late 2010
• Legislative procedure and EU Parliament;     2011..