Under the EU-MDR, the answer is no.Art. 52(7) says, "Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III."Because these devices don't use Annex IX, X, or XI there is no NB to issue an EU quality management system certificate.I'm making the assumption that such a certificate would include the new version of EN ISO 13485 that would have been issued to support the new regulations.
My answer is in two parts. First, implement a QMS that satisfies the requirements of Art. 10(9). There are many things required in ISO 13485:2016 that are not in Art. 10(9). Similarly, there are many things in Art. 10(9) that are not in ISO 13485:2016. A review of CEN/TR 17223:2016 will convince you that an ISO 13485:2016 QMS will fall far short of the EU-MDR requirements.Second, to whom would you demonstrate your QMS? Nobody will audit you (with one rare exception), so there is nobody to ask for an ISO 13485:2016 certificate. The rare exception is that the competent authority can audit you. However, they should not ask for the certificate because it is not a requirement.You must maintain the technical document on your products as required by Annex II and Annex III. There is no NB to audit it. However, your Authorized Representative will review your technical documentation and should point out any discrepancies. (The AR will have a Person Responsible with the required competence to conduct the review.)
Ed,I'm in total agreement.Such Class I devices, however, are a special case. They don't require an NB and they don't require conformity assessment using Annex IX, annex X, or Annex XI.A harmonized standard is not a requirement, even if they were to exist. Some NBs require harmonized standard implementation and some do not for the MDD. Leonard Eisner recently commented on the issues this raises with standards in the IEC 60601-1 family. It will be interesting to see their position on May 26, 2020.A manufacturer of such a Class I device must complete the CE Mark process by May 26, 2020. The Article 120 transition does not apply. However, such a manufacturer does not have to implement ISO 13485:2016 as the QMS for those devices.
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
email@example.com+1 301 770 2920
JoinMy RAPS DashboardLearn More