Important information for our clients in the area of medical devices
As of August 2014, recommendation 2013/473/EU of the EU Commission
The PIP scandal damaged the trust of patients, doctors and the general public in medical devices. As a result of this situation, and in order to improve the safety of medical devices, the European Commission made recommendations on 25 Sept. 2013 for cooperation between the notified bodies and the manufacturers of medical devices. It is hoped that the implementation of these recommendations will restore the faith of patients, doctors and the general public in the medical device industry. Recommendations were made for the performance of unannounced audits of medical device manufacturers, and where appropriate also of their suppliers/subcontractors, and for product evaluations. The Commission is issuing no new requirements relative to the current legal situation. It considers the recommendation an interpretative clarification for the implementation of the existing Medical Devices Directive.
TÜV NORD CERT and other renowned notified bodies will be following the recommendations of the EU Commission. Procedures and regulations for the performance of planned, unannounced audits and inspections of product samples are currently being implemented within the framework of conformity assessment and monitoring procedures. Furthermore, TÜV NORD CERT and other notified bodies in Europe have also signed a code of conduct (www.team-nb.org). The aim of the voluntary initiative is to improve the implementation of European regulations, and to harmonise the requirements for medical device manufacturers.
Important: Only manufacturers that produce products in categories I sterile, I with measurement function, IIa, IIb and III, are affected by the performance of unannounced audits and where appropriate testing of product samples. The performance of unannounced audits and where appropriate testing of product samples are necessary, amongst other things, in order to ensure maintenance of certification and the conformity of the medical device. The implementation of the recommendations is an organisational challenge not only for the relevant manufacturers, but also for the notified bodies. All relevant manufacturers must permit their notified bodies access to the company/production facilities and products at all times.
All customers are required to inform the notified body in writing, at the latest by the end of the 2nd calendar week of a current calendar year, regarding the times of business closures/operational holidays during the current calendar year. Changes in the planning during a year must likewise be reported immediately in writing. This also includes critical suppliers. (Source: Federal Gazette official section 15.06.2016 B4, point 4.4) If the OEM (original equipment manufacturer) at multiple PLM (private label manufacturers) has already been subjected to an UAA (unannounced audit) by another notified body, the assessment report can be accepted by TÜV NORD CERT, provided that we have been informed of this in advance. Here you can find the form sheet for notification of production-free times. The notification should be sent to email@example.com.
What can you do now in preparation? Our recommendation: Review your contracts with your suppliers and subcontractors to ensure that they are preparing for the recommendations of the EU Commission. Prepare corresponding action plans for the performance of unannounced audits and define responsibilities in advance.
This information is also intended for our DIN EN ISO 13485 customers. Even if you are not currently affected, but may be planning the market launch of a product in class I (S/M), you should take the aforementioned recommendations of the EU Commission into consideration when implementing a new product.