Europe Rules and Challenges of one of the largest markets

qtec group I qtec EuRep I qtec Services I qtec Consult I qtec Academy

Europe – Rules and Challenges of one of the largest markets for medical devices


Agenda:

Ways to bring products/ materials

into the european market

Future requirements for supplier of

products/ raw materials

Requirements for manufacturer of

medical devices from may 2021

Economic Operator – Requirements

and Interfaces

Authorized Representatives as your

new best friend

Conclusion



Many roads lead to Rome…

two to the european market

as a producer for a medical device-manufacturer within the european market

Means: it`s not your name or your brand on the device and you’re not responsible for CE marking


As a producer you must:

• grant your customer full access to the product documentation:

• drawings

• suppliers

• production information: validation/ qualification documentation of your processes

• grant access for notified bodies also for unannounced audits

• ensure that your customer is informed before you make any changes to your processes (including the supply chain)


Premier class…

Manufacturer of medical devices

person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark


DevelopmentConformity Assessment

CE marking Market Entry

Post-Market Surveillance

✓ Technical Documentation according to Annex II and III of the MDR

✓ In all cases other than class I* involvement of a notified body for conformity assessment including audits and assessment of technical documentation

✓ PRRC: Person responsible for regulatory compliance which is qualified to ensure compliance within your company located at your site

✓ Authorized Representative located within the EU*(non-sterile, no measuring function, no re-usable surgical instrument)


Economic operators

The team for your market and compliance success


Manufacturer

Importer

Distributor

Distributor

Distributor

Importer

AuthorizedRepresentative

Manufacturer: own brand, own name = full responsibility

Authorized Representative: is assigned by the manufacturer and „act on the manufacturer's behalf in relation to specified tasks” = the mandate

Importer: places a device from a third country on the Union market;

Distributor: person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service


How the Authorized Representative becomes the manufacturers new best friend

And why you should choose your partner very carefully


As a manufacturer you are responsible for:• establish a risk management system according to EN ISO 14971• conduct a clinical evaluation in accordance with the MDR• draw and keep up to date a technical documentation in accordance with Annex

II and III of the MDR• draw up a Declaration of Conformity and affix the CE marking on the device• comply with the requirements on UDI labeling and registration• assign an authorized representative for all of the devices• implement a quality management system (EN ISO 13485)• Implement and keep up to date a post-market-surveillance system and a system

for reporting and recording of incidents, field safety and corrective actions and for trend reporting

→ You cannot hand over any of these responsibilities to a third party

Need help? With the post-market-surveillance thing, the communication to notified bodies and competent authorities?


What the Authorized Representative must do:

✓ Check on your technical documentation, your Declaration of Conformity and your chosen conformity assessment route

✓ Store a copy of your technical documentation to provide it to competent authorities

✓ Check on your registration obligations

✓ Forward information from the market to you

✓ Cooperate and communicate with the notified bodies and competent authorities in case of any incident or report from the market

✓ Terminate the mandate if you act contrary to your obligations


What the Authorized Representative can do for you:

✓ Identify and close GAPs in your technical documentation

✓ Guides you with the most suitable conformity assessment route and the communication with the notified body

✓ Guide you through the respective national registration obligations

✓ Gather actively information from the market for your post-market-surveillance system

✓ Support you in case of incidents or problems with the national competent authorities

✓ Provide you with updates on new european or national regulatory requirements

✓ Make sure you have always the current and valid standards and guidance's available


Summary:

• Much higher stakes for medical device manufacturers from may 2021 – countdown is running

• Post-Market-Surveillance and registration obligations also for legacy devices

• More requirements for documentation and labeling of devices

• New classification rules for devices and additional procedures for conformity assessment

• Full responsibility of manufacturers for the complete technical documentation, supply chain and subcontractors



• Full Service Authorized Representative

• Qualified PRRC• Member of the qtec group

• Over 60 + compliance, regulatory and design control experts

[email protected]

mailto:[email protected]

Documents

Europe Rules and Challenges of one of the largest markets