EU Commission Implementing Regulation No. 920/2013 establishes a new framework for the designation and supervision of Notified Bodies operating under the EU’s Medical Device Directive and the EU’s Directive for Active Implantable Medical Devices.
Procedure for the initial designation of new Notified Bodies
Designation now requires a thorough assessment and an on-site evaluation, conducted by the designating authority in the EU member state, where the conformity assessment body is established, designating authorities of two other member states, and the EU Commission.
Extensions and renewals of existing Notified Body designations
Designations are valid for five years. Existing designations exceeding five years or designations without a stated validity period must be renewed by the end of 2016. This requires the same assessment and on-site evaluation applicable to new applicants.
Notified Bodies must have internal experts with suitable experience and knowledge
The Commission will assess the qualifications of Notified Body personnel who conduct conformity assessments to ensure that they have the required experience and knowledge. This will address functional areas such as auditing, product evaluation/testing and design dossier/file reviews, device technologies, and focus areas such as biocompatibility, sterilization, materials of animal origin and clinical evaluation. If the Notified Body uses subcontractors and external experts, the Notified Body must have internal resources sufficient to verify the appropriateness and validity of expert opinions.
Surveillance and monitoring of Notified Body activity
Notified Bodies are now subject to formal reviews, including file reviews, on-site assessments, including on-site unannounced audits and observed audits. Notified Bodies with more than 100 clients will be evaluated at least once every 12 months, all others will be evaluated at least once every 18 months.
Investigation of the competence of Notified Bodies
The EU Commission can initiate investigations when the competence of a Notified Body is questioned. When a Notified Body no longer meets the requirements, the Commission can ask a member state to take corrective action, including the removal of Notified Body designation.
Steps Medical Device manufacturers can take to minimize disruptions
These changes are likely to result in a number of Notified Bodies losing their status, thereby reducing the overall number of Notified Bodies qualified to assess Medical Devices. Particularly at risk are Notified Bodies that do not have internal experts with the experience and knowledge needed to fulfill the requirements for designation. Medical Device manufacturers should consider taking the following steps to reduce the risks associated with these changes:
Evaluate your anticipated need for Notified Body services during the next three to five years by developing a schedule of new Medical Devices that will require approval. Include an analysis of the technologies involved and to what extent these are in the Commission’s focus areas including novel, invasive and implantable devices.
Conduct an evaluation of your current Notified Body to determine whether it can effectively handle your current and anticipated assessment needs, particularly with respect to the extent of internal competence of reviewers and assessors. Ask if they are willing to invest in additional internal experts if gaps exist relative to their current product and service areas.
Discuss your anticipated needs with your Notified Body representative to confirm your evaluation, and to identify possible options that meet your product development timetable.
If you have doubts about your current Notified Body, initiate discussions with other qualified Notified Bodies to identify and evaluate possible alternatives.
TÜV SÜD Product Service GmbH is the world’s largest EU Notified Body for Medical Devices and has the most experienced and most knowledgeable staff of internal experts covering the broad range of review and assessment services that we offer to clients in virtually all Medical Devices product areas.