MEDICAL DEVICE, the OBL or OEM contract clauses

Production outsourcing and legal contract OBL or OEM: which clauses are needed?

On September 2013, the UE Commission has issued 2 legal provision, aiming at enforcing and uniforming the Notify Body control activity:

Commission Implementing Regulation UE No 920/2013 of 24 September 2013on the designation and supervision of notified bodies
Commission Recommendation of 24 September 2013 ?on the audits and assessments performed by notified bodies in the field of medical devices

In particular, the Recommendation includes very important rules concerning Notify Body’s controls in case of production outsourcing

These rules especially focus on the manufacturer’s duties in outsourcing production.

The main ones are:

Notify Body

- have to account as critical subcontractors not only direct suppliers but also suppliers of suppliers (subsuppliers), or even suppliers further down the supply chain;

- can sign arrangements with manufacturers only when the NB receives access to all critical documents from the subcontractors and thus to all sites where the devices are produced, regardless of the length of the contractual chain between the manufacturer and the subcontractor or supplier.

Otherwise, the manufacturer must:

(a) fulfil their obligations themselves regardless of any partial or total outsourcing of the production via subcontractors or suppliers;

(b) fulfil their obligation to have at their disposal the full technical documentation and/or of a quality system by referring to the technical documentation of a subcontractor or supplier and/or to their quality system;

(c) integrate the quality system of critical subcontractors and of crucial suppliers with their quality system;

(d) control the quality of services provided and of components supplied and the quality of production thereof regardless of the length of the contractual chain between the manufacturer and the subcontractor or supplier.

Therefore, the Notify Body will check that the contract between the manufacturer and the supplier complies with the provisions above described.

Consequently the current contracts have to be redraft in according to the same provisions.