EU Medical Device Regulations

1) The first thing you need is to get a qualified PRRC (person responsible for regulatory compliance). Usually, it is the same person as the management representative as defined by ISO 13485. However, this can be sub-contracted to a qualified consultant. Follow to MDCG documents as per link here on guidance of implementation for EU MDR. This can be downloaded here: Guidance – MDCG endorsed documents and other guidance (europa.eu)

2) Next you need to classify your device in accordance to Annex VIII of Medical Device Regulation (MDR). You can get the latest copy from the European commission website link above. 

3) Developed a Quality Management System (QMS) according to ISO 13485. If you are class I self-certified product, there is no need to get audited by a Certification Body (Such as TUV, BSI, SGS etc). The reason why you want to develop a QMS first before doing up technical documentation is because you can start documenting your specifications, design inputs, outputs in an orderly and official manner. This is to prevent the need to do retrospective documentation after the design of your product is completed.

4) Developed the technical file according to Annex II and III of MDR. You can visit here to see how can do the General Safety and Performance Requirements. The format is slightly different from the Essential Requirement checklist from the old MDD. Visit here for layman explanation on the requirement for technical fie. Visit here to see the mistakes to avoid when drafting the clinical evaluation report (CE). Please note CER is not that simple to pass CE requirements anymore under MDR and Meddev 2.7.1 Rev 4. Even experience regulatory personnel may need to seek experienced clinical writers to review or draft the CER for the manufacturer. Click here to see other mistakes to avoid when transiting from MDD to MDR.

Also remember to get your Unique Device Identifier (UDI) from organization like GS1. See here to see UDI implementation timeline. Also, you would need to select your conformity assessment route. Most companies would choose Annex IX as the default. Again, this is not needed for Class I self-certified product. 

5) Draft the EU DOC (Declaration of Conformity) before the external audit. This is needed because the EC REP or Notified Body usually wants to see how you draft the EC DOC. Click here to see an example.

6) Appoint an EC REP/ EU Authorised Representative if the manufacturer does not reside in EU.

7) Get audited by Notified Body. If you are class I self-certified product, there is no need to get audited by a Notified Body (Such as TUV, BSI, SGS etc). Usually for the first time, manufacturers get ISO 13485 certificate before getting CE certification. However, some manufacturers prefer to get both at the same time. For annual surveillance audit, manufacturers prefer to use one service provider to do the external audit to prevent multiple audits in one year. 

8) So now you have the UDI, CE Cert and EC REP, the Manufacturer can now do medical device registration via EUDAMED via this link: MDR-Eudamed – Welcome to EUDAMED (europa.eu)! 

Actor registration guidance can be found here: https://health.ec.europa.eu/medical-devices-eudamed/actor-registration-module_en 

UDI Device registration guidance can be found here: https://health.ec.europa.eu/medical-devices-eudamed/udidevices-registration_en  After this step you can now launch your product in EU and claim that your Medical Device has CE Marking!