Although experts focus mainly of the impact of the Regulation (EU) 2017/745 (MDR) on the activities of companies involved in medical devices, the notified bodies have already been involved in the various changes and they will be increasingly involved in the future.
Notified bodies will not only have to be prepared to carry out inspections and assessments in accordance with the MDR requirements, but they also have to be designated to be allowed to perform the conformity assessments and issue the CE certificates according to the MDR.
Many notified bodies have already started the procedure for obtaining the MDR designation, in order to be able to issue CE marks compliant with the regulation within the date of MDR full application on 26th May 2020.
However, the designation process is very long and complex; as of February 2020, only 3 months before the entry into force of the new regulation, only the following notified bodies have been designated:
|BSI Assurance UK Ltd||United Kingdom|
|BSI Group The Netherlands B.V.||Netherlands|
|DARE!! Services B.V.||Netherlands|
|DEKRA Certification B.V.||Netherlands|
|DEKRA Certification GmbH||Germany|
|DNV GL Presafe AS||Norway|
|IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.||Italy|
|MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH||Germany|
|National Standards Authority of Ireland (NSAI)||Ireland|
|TÜV Rheinland LGA Products GmbH||Germany|
|TÜV SÜD Product Service GmbH Zertifizierstellen||Germany|
A complete and constantly updated list of MDR designed notified bodies can be found on NANDO database.
To date, the number of notified bodies is very limited, and this can be a critical bottleneck for companies that need to mark their products in accordance with regulation 2017/745.
However, in addition to a continuous monitoring of the situation, there are activities that manufacturers can perform to carry on with the activities and to be prepared.
For example, it is highly suggested to conduct a gap analysis on the technical files to understand which activities must be planned; it is recommended to work on the quality system to understand how and where this must be updated to cover the new requirements and obviously it would be optimal to make adequate training on the new regulation to the staff involved in medical device activity.
Regulatory Pharma Net is at your disposal to offer you support to manage the transition from the current directive to the new regulation.