Medical Device Regulations - Update

On the 19^th of June 2015, the Council agreed the substance of its negotiating stance on two draft regulations aimed at modernizing EU rules on medical devices and in vitro diagnostic medical devices. This is a step towards providing the presidency with a mandate to start talks with the European Parliament with a view to reach an agreement as early as possible.

The two draft regulations on medical devices cover a wide range of products, from sticking plasters to hip replacements, pacemakers and laboratory tests for assessment of medical interventions.

The main objective of the two draft regulations is to ensure that medical devices are safe. This would be achieved by strengthening the rules on placing devices on the market and tightening surveillance once they are available.

"We are pleased that under the Latvian presidency major progress could be achieved to strengthen the rules on medical devices. Today's agreement is a decisive step forward to improve patient safety and strengthen European competitiveness. Further work both within the Council and between the Council and the European Parliament is, however, needed to ensure that the benefits of the new rules are put into practice", said Guntis Belēvičs, the Latvian minister for health and President of the Council.

Topic	Council position on 19 June 2015:
Post-market surveillance, vigilance and market surveillance	The council has carried out a substantial rewrite of Chapter VII on post-market surveillance, vigilance and market surveillance. It has added explicit provisions on manufacturers' responsibilities for the clinical follow-up of the quality, performance and safety of devices placed on the market. It also increases the powers of competent authorities, for example, by stating that 'where necessary, a competent authority may intervene in a manufacturer's investigation or initiate an independent investigation' and in terms of powers following risks identified following the analysis of vigilance data. In particular it requires competent authorities to allocate a sufficient number of competent human and material resources needed to carry out market surveillance activities. It also advices manufacturers 'not to play down the level of risk' in field safety notices and provides details on how co-ordination between competent authorities should work in the analysis of incidents.
Qualified Person (QP)	Agreement with the parliament that the phrase 'person responsible for regulatory compliance' should replace the term 'qualified person'. In the case of the Council, the phrase it uses is person responsible for regulatory compliance activities. Clarification that the QP shall ensure that the post-market surveillance obligations are complied with. In the MDR proposal is required that medtech companies should have a qualified person (QP) within their organization who will oversee regulatory compliance. The Council has also amended the commission's text so that micro and small enterprises are exempt from having a QP person in-house; instead, these small business will be expected to have a regulatory consultant on contract.
UDI	Commission should endeavor to promote interoperability different UDI assigning entity systems with a view to minimizing financial and administrative burdens for economic operators and health institutions. UDI should be applied to device and higher levels of packaging (but not including shipping containers). Core data elements in UDI database to be available to public free of charge.
UDI timing	UDI must be affixed to devices by the following time limits after the date of applications of the Regulation: - Implantable an Class III devices: Within 1 year - Class IIa and IIb devices: Within 3 years - Class I devices: Within 5 years
Clinical evaluation and clinical investigations	The draft regulations provide also for strengthened provisions on clinical investigation with a view to increase the availability of reliable clinical data on medical devices. The Council focused its efforts in particular on the protection of those undergoing clinical trials. The Council has agreed substantial amendments to the wording concerning clinical evaluation and clinical investigations. For example, there is a new definition of clinical evaluation as 'A systematic and planned process to continuously generate, collect, analyze and assess' the clinical data tot verify the safety and performance of a device when used as intended by the manufacturer. It also expands the definition of clinical evaluation in Article 49 and introduces the concept of manufacturers having the option to consult an expert panel prior its clinical evaluation or clinical investigation as well as mandatory clinical investigations for Class III devices. It offers a much clearer explanation than before of where clinical investigations may not be necessary for Class III devices depending on whether the device in question has been designed by modifications of a device by the same or another manufacturer. It also lists 9 prerequisite conditions in Article 50 (5) for when clinical investigations can be carried out.
Devices manufactured and used in a single health institution	The Council lists a series of conditions that should be met if such devices are to escape the requirements of the regulation. In its view, member states retain the right to restrict manufacture and use of such devices and to inspect activities of health institution.
Common Technical Specifications	New being referred to as Common Specifications by the Council.
Devices incorporating medicinal product or composed of certain substances (Rule 21)	The Council has completely rewritten the classification rule for devices composed of substances or combinations of substances that are intended to be 'introduced into the human body via a body orifice, or applied on skin' (having deleted the phrase 'ingested, inhaled, or administered rectally or vaginally'). The new proposals foresee a distribution of relevant devices throughout the risk classes, rather than all placed in class III as with the European Commission's text.
Quality management System (QMS)	The Council places greater emphasis and more details on what QMS responsibilities should involve. This is a new key focus.
Insurance	Manufacturers should consider taking out appropriate product liability insurance (PL) or arranging for an equivalent financial guarantee to cover the costs associated with defective devices. An article (Article 50d) is also included for damage compensation for patients from participating in clinical investigations.
Software	The Council does not think that stand-alone software should be considered an active device.
Authorized Representatives (AR's)	The Council wants AR's to be given far greater responsibilities, including that the AR 'shall be legally liable for defective devices'.
Importers	More responsibilities for importers: include checking the device is registered electronically and adding details to registration. Also, obligation to check registration includes details on the AR. Obligation to cooperate with the manufacturer, AR and competent authorities to ensure the necessary corrective action to bring device into conformity, or to result in its withdrawal or recall.
Distributors	Again, more responsibilities for distributors. These include having to keep a register of complaints, of non-conforming products and of product recalls and withdrawals and to keep the manufacturer, and where available the AR, informed of such monitoring.
Implant card	Concept of implant card to be scrapped and replaced with 'information to be supplied to the patient with implanted device', covering aspects including UDI as well as the name, address and URL of the website of the manufacturer.
Compatibility and interoperability	Council has included new definitions of these terms, and included software compatibility and interoperability.
Nomenclature	Commission should ensure that a medical device nomenclature shpuld be available free of charge to manufacturers - and also other stakeholders, where reasonably practical.
Aesthetic products	The Council has significantly expanded the details of those products that would fall into the list of what it now describes as 'List of groups of products without an intended medical purpose'. It has also added equipment 'intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain'.

Placing on the market

Unlike pharmaceuticals, medical devices and in vitro diagnostic medical devices are not subject to pre-market authorization. Instead, they undergo a conformity assessment to establish whether they meet the applicable standards before they are placed on the market. Depending on the risk posed by a product, the assessment may involve a so-called notified body. This is an independent body with specific expertise for certain types of medical devices which assesses whether these medical devices meet the relevant standards.

The Council further tightened the rules for the designation of notified bodies, for the monitoring of their assessment activities by national competent authorities and for co-operation of those competent authorities. The new rules would also give notified bodies the right and duty to carry out unannounced factory inspections.

Post-market surveillance

The Council added explicit provisions on manufacturers' responsibilities for the follow-up of the quality, performance and safety of devices placed on the market.

More transparency for patients

The draft regulations seek to provide patients more transparency on the available devices, and increase their traceability.

Patients who are implanted with a device would be given key information on the product, including any precautions which might need to be taken. Manufacturers of high-risk devices would have to make publicly available a summary of their safety and performance, with key elements of the clinical data.

Increased traceability

Manufacturers of medical devices would have to fit their products with a unique device identification to ensure traceability. Manufacturers and importers of both categories of products would have to register themselves and the devices they place on the EU market in a central database. An EU portal would be set up where manufacturers would have to report serious incidents and corrective actions they have taken to reduce the risk of recurrence. The Council took particular care to ensure that the traceability and identification rules can be implemented in practice.

Next steps

The agreement on the substance of the Council's negotiating stance will allow the next presidency to take contact with the European Parliament to prepare negotiations between the two institutions. Once the Council has finalized some outstanding technical work concerning the preamble of the two draft regulations, negotiations between the institutions will be able to start.