Hi!
New to this forum, found a lot of useful info by searching but nothing specific to our issue.
Case study: Recently established small family business, primarily focused on distributing a Class IIa medical device in Scandinavia. The product is certified according to MDD until 2024 and thus is a legacy device, currently marketed in other member states. According to the MDCG 2021-25 Guidance on legacy devices, most of the MDR regulations don't apply to distributors of legacy devices, in particular the Article 16 regulations. However, the manufacturer is currently working on the MDR re-certification of the device and thus we as distributors would also be required to follow the complete MDR regulations within about 2 years.
According to the MDR Article 16(4) and MDCG 2021-23 on the certification of distributors:
"... Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributor or importer complies with the requirements laid down in paragraph 3."
This seems like a pretty big change in the MDR that distributors will need product-specific certification regarding their quality management system, issued by a Notified Body. Has anybody had any contact with a Notified Body about this process?
How about all you manufacturers out there? Has this come up in your discussions with your distributors?
Any and all comments are welcome!
New to this forum, found a lot of useful info by searching but nothing specific to our issue.
Case study: Recently established small family business, primarily focused on distributing a Class IIa medical device in Scandinavia. The product is certified according to MDD until 2024 and thus is a legacy device, currently marketed in other member states. According to the MDCG 2021-25 Guidance on legacy devices, most of the MDR regulations don't apply to distributors of legacy devices, in particular the Article 16 regulations. However, the manufacturer is currently working on the MDR re-certification of the device and thus we as distributors would also be required to follow the complete MDR regulations within about 2 years.
According to the MDR Article 16(4) and MDCG 2021-23 on the certification of distributors:
"... Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributor or importer complies with the requirements laid down in paragraph 3."
This seems like a pretty big change in the MDR that distributors will need product-specific certification regarding their quality management system, issued by a Notified Body. Has anybody had any contact with a Notified Body about this process?
How about all you manufacturers out there? Has this come up in your discussions with your distributors?
Any and all comments are welcome!