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News and Views June 2017

  • One-year anniversary of the clinical evaluation guideline MEDDEV 2.7/1 rev 4 
  • New French notification requirements for risk class III products and implantable medical devices
  • Cooperation MDSS with Implantex PTE. LTD – Registration in Asia


One-year anniversary for the clinical evaluation guideline MEDDEV 2.7/1 rev 4
In some cases no mercy was shown in regards to the clinical evaluation of products with applying the clinical evaluation guideline MDDEV 2.7/1 rev4 for existing products.  
It is understandable if there is a new product that it should fulfill the new requirements.  However, products already being on the market for several years have been measured early on to same requirements.  The guideline provides for the timeline when a next evaluation should take place for a device and with a solid quality system a notified body would have the freedom for individual reviews and timelines taking the risk class of the product into consideration and with that working with the manufacturer to identify the right timing for an update for those products.  

The audit takes place on a regular schedule and a review of the clinical evaluation may be anticipated by the notified body.  It is less predictable and plannable should your product or company be inspected by the competent authority.  During the inspection competent authorities check the clinical evaluation also in particular for risk class I devices since no notified body will check those.  

The recommendation is that after one year of existence of the guideline the clinical evaluation should be in its final stages for almost all products and/or it is planned accordingly.  The new MDR requirements may already be taken into consideration.  This also applies in particular for risk class I products.  Should a manufacturer come to the conclusion that this does not apply then even that must be solidly documented!


New French notification requirements for risk class III products and implantable medical devices
With the decree no. 2016-1716 of 13 December 2016 the French authority is asking for additional information with the notification of risk class III products and implantable medical devices. 
The Decree shall become effective on July 1st, 2017 and refers to the obligation of submitting the summary of the characteristics for those devices before being put into service on the French national territory.  MDSS has prepared the translation in English of the Decree (certainly not an official one, always refer to the original law), which can be found on our website here.

MDSS would be happy to take over the task to submit the information on your behalf. We have inquired with the authority whether these new requirements apply to products MDSS has already notified and if updates need to be performed.  Unfortunately we have not received an answer from the authority. In general the interpretation of such a wording in Europe is that the law must be applied for each product.  Therefore, with the next device, which is being put into service in France, the new additional information should be available, even with a valid current registration in place.

Please consult the FAQ file published on ANSM website in relation to the newly issued Decree. An English version (unofficial translation performed by MDSS) can be found on our website here.
MDSS offers to submit the additional information. Should you need support with compiling the information, please let us know. Our initial review shows that the information would be readily available in your technical file/design dossier.  It is a matter of extracting the right information.


Cooperation MDSS with Implantex PTE. LTD – Registration in Asia
Implantex Pte. Ltd. (www.implantex-meditech-consulting.de) is a strategic consulting and regulatory advisory company for the medical devices, life sciences and healthcare industry, incorporated in Singapore. They help medical device; life science and healthcare companies understand and succeed in a very complex and dynamic marketplace.

Furthermore, Implantex Pte. Ltd. supports clients with medical device registrations, local in country representation, quality system compliance, reimbursement consulting, due diligence, partner and distributor search, distributor management and training and education in the field of medical device in the following countries:

Singapore, Malaysia, Indonesia, Thailand, Australia, Philippines, India, Pakistan, Afghanistan, Sri Lanka, Bangladesh and Nepal.

In addition, they offer medical device companies their market entry through their company pool as a cost effective method to enter new markets.


Your MDSS Team